Trial Outcomes & Findings for MM-398 (Nanoliposomal Irinotecan, Nal-IRI) to Determine Tumor Drug Levels and to Evaluate the Feasibility of Ferumoxytol Magnetic Resonance Imaging to Measure Tumor Associated Macrophages and to Predict Patient Response to Treatment (NCT NCT01770353)

NCT ID: NCT01770353

Last Updated: 2019-11-27

Results Overview

Two tumour biopsies were collected 72 hours after the first MM-398 IV infusion during Cycle 1 of the MM-398 Treatment phase of the Pilot phase for determination of tumour levels of irinotecan and SN-38 (an active metabolite). The lesions selected for biopsy were based on the results of the FMX-MRI obtained on Days 1, 2 and 4 of the FMX phase, and were collected from a previously non-biopsied lesion. The first core biopsy was taken in the region of the tumour that showed the greatest signal change on either the T2 or T1 sequences, based on FMX-MRI. The second core biopsy was taken from the region that showed the least signal change based on FMX-MRI, avoiding areas of necrosis.

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 45 participants
• Primary outcome timeframe: At Cycle 1 Day 4 in the Pilot phase.
• Results posted on: 2019-11-27

Participant Flow

Six study centres in the United States recruited subjects into this Phase 1, 2-phase, non-comparative, open-label study. Each phase consisted of 4 stages: screening, ferumoxytol (FMX) treatment, irinotecan liposome injection (MM-398) treatment and follow-up (30 days after last dose).

Subjects with solid tumours were recruited to the Pilot phase. Subjects with locally advanced or metastatic breast cancer (BC) were recruited to the Expansion phase which consisted of 3 cohorts dependent on BC tumour sub-types and the presence of active brain metastases. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.

Participant milestones

Measure	Pilot Phase: FMX Then MM-398 FMX phase: Subjects received a single bolus intravenous (IV) injection of 5 milligrams per kilogram (mg/kg) FMX (up to 510 mg) on Day 1. Subjects underwent FMX magnetic resonance imaging (MRI) scans and pre-MM-398 treatment biopsies on Days 1 to 4. MM-398 Treatment phase: Within 7 days of the FMX infusion, subjects received up to 70 milligrams per square metre (mg/m\^2) MM-398 free base equivalent (FBE) (Cycle 1 Day 1 \[C1D1\]) administered as an IV infusion over 90 minutes, repeated every 2 weeks until disease progression, unacceptable toxicity or withdrawal of consent.	Expansion Phase: FMX Then MM-398 FMX phase: Subjects received an IV infusion of 5 mg/kg FMX (up to 510 mg) administered over a minimum of 15 minutes on Day 1. Subjects underwent FMX-MRI scans and a pre-MM-398 treatment biopsy on Days 1 to 2. MM-398 Treatment phase: Within 7 days of the FMX infusion, subjects received up to 70 mg/m\^2 MM-398 FBE (C1D1) administered as an IV infusion over 90 minutes, repeated every 2 weeks until disease progression, unacceptable toxicity or withdrawal of consent. Cohort 1: Oestrogen receptor (ER) and/or progesterone receptor (PR)-positive BC and human epidermal growth factor receptor 2 (HER-2) negative BC. Cohort 2: Triple negative BC (TNBC). Cohort 3: BC with active brain metastasis.
Overall Study STARTED	15	30
Overall Study Received FMX	15	30
Overall Study Received FMX and MM-398	13	29
Overall Study COMPLETED	9	18
Overall Study NOT COMPLETED	6	12

Reasons for withdrawal

Measure	Pilot Phase: FMX Then MM-398 FMX phase: Subjects received a single bolus intravenous (IV) injection of 5 milligrams per kilogram (mg/kg) FMX (up to 510 mg) on Day 1. Subjects underwent FMX magnetic resonance imaging (MRI) scans and pre-MM-398 treatment biopsies on Days 1 to 4. MM-398 Treatment phase: Within 7 days of the FMX infusion, subjects received up to 70 milligrams per square metre (mg/m\^2) MM-398 free base equivalent (FBE) (Cycle 1 Day 1 \[C1D1\]) administered as an IV infusion over 90 minutes, repeated every 2 weeks until disease progression, unacceptable toxicity or withdrawal of consent.	Expansion Phase: FMX Then MM-398 FMX phase: Subjects received an IV infusion of 5 mg/kg FMX (up to 510 mg) administered over a minimum of 15 minutes on Day 1. Subjects underwent FMX-MRI scans and a pre-MM-398 treatment biopsy on Days 1 to 2. MM-398 Treatment phase: Within 7 days of the FMX infusion, subjects received up to 70 mg/m\^2 MM-398 FBE (C1D1) administered as an IV infusion over 90 minutes, repeated every 2 weeks until disease progression, unacceptable toxicity or withdrawal of consent. Cohort 1: Oestrogen receptor (ER) and/or progesterone receptor (PR)-positive BC and human epidermal growth factor receptor 2 (HER-2) negative BC. Cohort 2: Triple negative BC (TNBC). Cohort 3: BC with active brain metastasis.
Overall Study Progressive disease	2	1
Overall Study Adverse Event	0	1
Overall Study Protocol Violation	1	0
Overall Study Physician Decision	0	3
Overall Study Clinical deterioration	3	6
Overall Study Toxicity related diarrhoea + progression	0	1

Baseline Characteristics

MM-398 (Nanoliposomal Irinotecan, Nal-IRI) to Determine Tumor Drug Levels and to Evaluate the Feasibility of Ferumoxytol Magnetic Resonance Imaging to Measure Tumor Associated Macrophages and to Predict Patient Response to Treatment

Baseline characteristics by cohort

Measure	Pilot Phase: FMX Then MM-398 n=15 Participants FMX phase: Subjects received a single bolus IV injection of 5 mg/kg FMX (up to 510 mg) on Day 1. Subjects underwent FMX-MRI scans and pre-MM-398 treatment biopsies on Days 1 to 4. MM-398 Treatment phase: Within 7 days of the FMX infusion, subjects received up to 70 mg/m\^2 MM-398 FBE (C1D1) administered as an IV infusion over 90 minutes, repeated every 2 weeks until disease progression, unacceptable toxicity or withdrawal of consent.	Expansion Phase: FMX Then MM-398 n=30 Participants FMX phase: Subjects received an IV infusion of 5 mg/kg FMX (up to 510 mg) administered over a minimum of 15 minutes on Day 1. Subjects underwent FMX-MRI scans and a pre-MM-398 treatment biopsy on Days 1 to 2. MM-398 Treatment phase: Within 7 days of the FMX infusion, subjects received up to 70 mg/m\^2 MM-398 FBE (C1D1) administered as an IV infusion over 90 minutes, repeated every 2 weeks until disease progression, unacceptable toxicity or withdrawal of consent. Cohort 1: ER and/or PR-positive BC and HER-2 negative BC. Cohort 2: TNBC. Cohort 3: BC with active brain metastasis.	Total n=45 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	9 Participants n=5 Participants	25 Participants n=7 Participants	34 Participants n=5 Participants
Age, Categorical >=65 years	6 Participants n=5 Participants	5 Participants n=7 Participants	11 Participants n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants	30 Participants n=7 Participants	41 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	0 Participants n=7 Participants	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	13 Participants n=5 Participants	27 Participants n=7 Participants	40 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) White	14 Participants n=5 Participants	23 Participants n=7 Participants	37 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants

PRIMARY outcome

Timeframe: At Cycle 1 Day 4 in the Pilot phase.

Population: The efficacy evaluable population included all subjects who received at least 1 dose of MM-398.

Two tumour biopsies were collected 72 hours after the first MM-398 IV infusion during Cycle 1 of the MM-398 Treatment phase of the Pilot phase for determination of tumour levels of irinotecan and SN-38 (an active metabolite). The lesions selected for biopsy were based on the results of the FMX-MRI obtained on Days 1, 2 and 4 of the FMX phase, and were collected from a previously non-biopsied lesion. The first core biopsy was taken in the region of the tumour that showed the greatest signal change on either the T2 or T1 sequences, based on FMX-MRI. The second core biopsy was taken from the region that showed the least signal change based on FMX-MRI, avoiding areas of necrosis.

Outcome measures

Measure	Pilot Phase: FMX Then MM-398 n=13 Participants FMX phase: Subjects received a single bolus IV injection of 5 mg/kg FMX (up to 510 mg) on Day 1. Subjects underwent FMX-MRI scans and pre-MM-398 treatment biopsies on Days 1 to 4. MM-398 Treatment phase: Within 7 days of the FMX infusion, subjects received up to 70 mg/m\^2 MM-398 FBE (C1D1) administered as an IV infusion over 90 minutes, repeated every 2 weeks until disease progression, unacceptable toxicity or withdrawal of consent.	Expansion Phase: Cohort 2 Subjects with TNBC. FMX phase: Subjects received an IV infusion of 5 mg/kg FMX (up to 510 mg) administered over a minimum of 15 minutes on Day 1. Subjects underwent FMX-MRI scans and a pre-MM-398 treatment biopsy on Days 1 to 2. MM-398 Treatment phase: Within 7 days of the FMX infusion, subjects received up to 70 mg/m\^2 MM-398 FBE (C1D1) administered as an IV infusion over 90 minutes, repeated every 2 weeks until disease progression, unacceptable toxicity or withdrawal of consent.	Expansion Phase: Cohort 3 Subjects with BC with active brain metastasis. FMX phase: Subjects received an IV infusion of 5 mg/kg FMX (up to 510 mg) administered over a minimum of 15 minutes on Day 1. Subjects underwent FMX-MRI scans and a pre-MM-398 treatment biopsy on Days 1 to 2. MM-398 Treatment phase: Within 7 days of the FMX infusion, subjects received up to 70 mg/m\^2 MM-398 FBE (C1D1) administered as an IV infusion over 90 minutes, repeated every 2 weeks until disease progression, unacceptable toxicity or withdrawal of consent.	Expansion Phase: Cohort 3 Subjects with BC with active brain metastasis. FMX phase: Subjects received an IV infusion of 5 mg/kg FMX (up to 510 mg) administered over a minimum of 15 minutes on Day 1. Subjects underwent FMX-MRI scans and a pre-MM-398 treatment biopsy on Days 1 to 2. MM-398 Treatment phase: Within 7 days of the FMX infusion, subjects received up to 70 mg/m\^2 MM-398 FBE (C1D1) administered as an IV infusion over 90 minutes, repeated every 2 weeks until disease progression, unacceptable toxicity or withdrawal of consent.
Pilot Phase: Tumour Levels of Irinotecan and SN-38 at Cycle 1 Day 4 SN-38	38.1 nanograms per gram (ng/g) Standard Deviation 91.5	—	—	—
Pilot Phase: Tumour Levels of Irinotecan and SN-38 at Cycle 1 Day 4 Irinotecan	4253 nanograms per gram (ng/g) Standard Deviation 3600	—	—	—

PRIMARY outcome

Timeframe: Expansion phase Cycle 1: Pre FMX dose, 1-4 hours post FMX dose, 16-24 hours post FMX dose, 2 weeks Post FMX dose.

Population: The pharmacodynamic evaluable population included all subjects who received at least 1 dose of MM-398 and who had pre-treatment FMX-MRI scan(s) and radiological scans at 8 weeks.

Feasibility of FMX quantitation in tumour lesion was assessed through the acquisition of baseline (pre-FMX dose) and follow-up (post FMX dose) scans of sufficient quality to enable quantitative analysis to be performed. Quality was assessed by summarising scans as adequate for tumour evaluation or suboptimal but for which evaluation was completed for evaluation. Two FMX-MRI scans were taken on Day 1 (pre-FMX dosing) and on Day 2 (16-24 hours post dose) of the FMX phase. One MRI scan was also taken at 1-4 hours post FMX dose (Day 1 of FMX phase) and at 2 weeks post FMX dose (Day 15 of the MM-398 phase). It was possible for a subject to have 2 FMX-MRI scans for the same visit and timepoint corresponding to a scan target location. The number of MRI scan results that were assessed to be adequate or suboptimal at each timepoint are presented.

Outcome measures

Measure	Pilot Phase: FMX Then MM-398 n=7 Scans FMX phase: Subjects received a single bolus IV injection of 5 mg/kg FMX (up to 510 mg) on Day 1. Subjects underwent FMX-MRI scans and pre-MM-398 treatment biopsies on Days 1 to 4. MM-398 Treatment phase: Within 7 days of the FMX infusion, subjects received up to 70 mg/m\^2 MM-398 FBE (C1D1) administered as an IV infusion over 90 minutes, repeated every 2 weeks until disease progression, unacceptable toxicity or withdrawal of consent.	Expansion Phase: Cohort 2 n=5 Scans Subjects with TNBC. FMX phase: Subjects received an IV infusion of 5 mg/kg FMX (up to 510 mg) administered over a minimum of 15 minutes on Day 1. Subjects underwent FMX-MRI scans and a pre-MM-398 treatment biopsy on Days 1 to 2. MM-398 Treatment phase: Within 7 days of the FMX infusion, subjects received up to 70 mg/m\^2 MM-398 FBE (C1D1) administered as an IV infusion over 90 minutes, repeated every 2 weeks until disease progression, unacceptable toxicity or withdrawal of consent.	Expansion Phase: Cohort 3 n=11 Scans Subjects with BC with active brain metastasis. FMX phase: Subjects received an IV infusion of 5 mg/kg FMX (up to 510 mg) administered over a minimum of 15 minutes on Day 1. Subjects underwent FMX-MRI scans and a pre-MM-398 treatment biopsy on Days 1 to 2. MM-398 Treatment phase: Within 7 days of the FMX infusion, subjects received up to 70 mg/m\^2 MM-398 FBE (C1D1) administered as an IV infusion over 90 minutes, repeated every 2 weeks until disease progression, unacceptable toxicity or withdrawal of consent.	Expansion Phase: Cohort 3 Subjects with BC with active brain metastasis. FMX phase: Subjects received an IV infusion of 5 mg/kg FMX (up to 510 mg) administered over a minimum of 15 minutes on Day 1. Subjects underwent FMX-MRI scans and a pre-MM-398 treatment biopsy on Days 1 to 2. MM-398 Treatment phase: Within 7 days of the FMX infusion, subjects received up to 70 mg/m\^2 MM-398 FBE (C1D1) administered as an IV infusion over 90 minutes, repeated every 2 weeks until disease progression, unacceptable toxicity or withdrawal of consent.
Expansion Phase: Impact of the Quality of MRI Scan on Tumour Evaluation Pre-FMX Dose (1): adequate	4 examined scans	3 examined scans	7 examined scans	—
Expansion Phase: Impact of the Quality of MRI Scan on Tumour Evaluation 16-24 hours Post FMX (1): suboptimal	3 examined scans	2 examined scans	4 examined scans	—
Expansion Phase: Impact of the Quality of MRI Scan on Tumour Evaluation 16-24 hours Post FMX (2): suboptimal	1 examined scans	—	—	—
Expansion Phase: Impact of the Quality of MRI Scan on Tumour Evaluation Post FMX Day 15: adequate	0 examined scans	2 examined scans	—	—
Expansion Phase: Impact of the Quality of MRI Scan on Tumour Evaluation Post FMX Day 15: suboptimal	1 examined scans	1 examined scans	—	—
Expansion Phase: Impact of the Quality of MRI Scan on Tumour Evaluation Pre-FMX Dose (1): suboptimal	3 examined scans	2 examined scans	4 examined scans	—
Expansion Phase: Impact of the Quality of MRI Scan on Tumour Evaluation Pre-FMX Dose (2): adequate	0 examined scans	1 examined scans	—	—
Expansion Phase: Impact of the Quality of MRI Scan on Tumour Evaluation Pre-FMX Dose (2): suboptimal	1 examined scans	1 examined scans	—	—
Expansion Phase: Impact of the Quality of MRI Scan on Tumour Evaluation 1-4 hours Post FMX: adequate	4 examined scans	1 examined scans	5 examined scans	—
Expansion Phase: Impact of the Quality of MRI Scan on Tumour Evaluation 1-4 hours Post FMX: suboptimal	2 examined scans	1 examined scans	2 examined scans	—
Expansion Phase: Impact of the Quality of MRI Scan on Tumour Evaluation 16-24 hours Post FMX (1): adequate	4 examined scans	3 examined scans	6 examined scans	—
Expansion Phase: Impact of the Quality of MRI Scan on Tumour Evaluation 16-24 hours Post FMX (2): adequate	0 examined scans	—	—	—

PRIMARY outcome

Timeframe: Expansion phase: C1D2 FMX phase, and every 8 weeks for RECIST assessments from C1D1 until disease progression, unacceptable toxicity or withdrawal of consent.

Population: The pharmacodynamic evaluable population included all subjects who received at least 1 dose of MM-398 and who had pre-treatment FMX-MRI scan(s) and radiological scans at 8 weeks.

FMX tumour uptake was classified as 'low tumour uptake' or 'high tumour uptake', and was determined for 16 to 24-hours post-FMX dosing. The FMX uptake in a subject's lesions was classified using the median of the baseline-corrected FMX values at that timepoint across all subjects. The best radiological overall tumour response to MM-398 from the beginning to the end of the study was assessed using both the Investigator and imaging results per Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1 (Non-central nervous system [CNS] assessments; Cohorts 1, 2 and 3). Tumour response was classified as a Complete Response (CR), Partial Response (PR), Stable Disease (SD) or Progressive Disease (PD). BOR is presented by tumour uptake classification at 16-24 hours post-FMX dose by cohort for the non-CNS RECIST assessment.

Outcome measures

Measure	Pilot Phase: FMX Then MM-398 n=7 Participants FMX phase: Subjects received a single bolus IV injection of 5 mg/kg FMX (up to 510 mg) on Day 1. Subjects underwent FMX-MRI scans and pre-MM-398 treatment biopsies on Days 1 to 4. MM-398 Treatment phase: Within 7 days of the FMX infusion, subjects received up to 70 mg/m\^2 MM-398 FBE (C1D1) administered as an IV infusion over 90 minutes, repeated every 2 weeks until disease progression, unacceptable toxicity or withdrawal of consent.	Expansion Phase: Cohort 2 n=5 Participants Subjects with TNBC. FMX phase: Subjects received an IV infusion of 5 mg/kg FMX (up to 510 mg) administered over a minimum of 15 minutes on Day 1. Subjects underwent FMX-MRI scans and a pre-MM-398 treatment biopsy on Days 1 to 2. MM-398 Treatment phase: Within 7 days of the FMX infusion, subjects received up to 70 mg/m\^2 MM-398 FBE (C1D1) administered as an IV infusion over 90 minutes, repeated every 2 weeks until disease progression, unacceptable toxicity or withdrawal of consent.	Expansion Phase: Cohort 3 n=6 Participants Subjects with BC with active brain metastasis. FMX phase: Subjects received an IV infusion of 5 mg/kg FMX (up to 510 mg) administered over a minimum of 15 minutes on Day 1. Subjects underwent FMX-MRI scans and a pre-MM-398 treatment biopsy on Days 1 to 2. MM-398 Treatment phase: Within 7 days of the FMX infusion, subjects received up to 70 mg/m\^2 MM-398 FBE (C1D1) administered as an IV infusion over 90 minutes, repeated every 2 weeks until disease progression, unacceptable toxicity or withdrawal of consent.	Expansion Phase: Cohort 3 Subjects with BC with active brain metastasis. FMX phase: Subjects received an IV infusion of 5 mg/kg FMX (up to 510 mg) administered over a minimum of 15 minutes on Day 1. Subjects underwent FMX-MRI scans and a pre-MM-398 treatment biopsy on Days 1 to 2. MM-398 Treatment phase: Within 7 days of the FMX infusion, subjects received up to 70 mg/m\^2 MM-398 FBE (C1D1) administered as an IV infusion over 90 minutes, repeated every 2 weeks until disease progression, unacceptable toxicity or withdrawal of consent.
Expansion Phase: Best Overall Tumour Response (BOR) by Tumour FMX Uptake Classification at 16 - 24 Hours Post-FMX Dose High tumour uptake and CR	1 Participants	0 Participants	0 Participants	—
Expansion Phase: Best Overall Tumour Response (BOR) by Tumour FMX Uptake Classification at 16 - 24 Hours Post-FMX Dose High tumour uptake and PR	1 Participants	3 Participants	0 Participants	—
Expansion Phase: Best Overall Tumour Response (BOR) by Tumour FMX Uptake Classification at 16 - 24 Hours Post-FMX Dose Low tumour uptake and CR	1 Participants	0 Participants	1 Participants	—
Expansion Phase: Best Overall Tumour Response (BOR) by Tumour FMX Uptake Classification at 16 - 24 Hours Post-FMX Dose Low tumour uptake and PR	1 Participants	0 Participants	2 Participants	—
Expansion Phase: Best Overall Tumour Response (BOR) by Tumour FMX Uptake Classification at 16 - 24 Hours Post-FMX Dose Low tumour uptake and SD	1 Participants	0 Participants	2 Participants	—
Expansion Phase: Best Overall Tumour Response (BOR) by Tumour FMX Uptake Classification at 16 - 24 Hours Post-FMX Dose Low tumour uptake and Non-CR/Non-PD	0 Participants	0 Participants	0 Participants	—
Expansion Phase: Best Overall Tumour Response (BOR) by Tumour FMX Uptake Classification at 16 - 24 Hours Post-FMX Dose Low tumour uptake and PD	0 Participants	0 Participants	1 Participants	—
Expansion Phase: Best Overall Tumour Response (BOR) by Tumour FMX Uptake Classification at 16 - 24 Hours Post-FMX Dose High tumour uptake and SD	0 Participants	2 Participants	0 Participants	—
Expansion Phase: Best Overall Tumour Response (BOR) by Tumour FMX Uptake Classification at 16 - 24 Hours Post-FMX Dose High tumour uptake and Non-CR/Non-PD	0 Participants	0 Participants	0 Participants	—
Expansion Phase: Best Overall Tumour Response (BOR) by Tumour FMX Uptake Classification at 16 - 24 Hours Post-FMX Dose High tumour uptake and PD	2 Participants	0 Participants	0 Participants	—

SECONDARY outcome

Timeframe: Baseline and every 8 weeks from C1D1 until disease progression, unacceptable toxicity or withdrawal of consent.

Population: The efficacy evaluable population consists of all subjects who received at least 1 dose of MM-398.

PFS was defined as the time in months from first dose of MM-398 to the date of radiologic disease progression by RECIST per Investigator assessment or death due to any cause, whichever occurred first.

The date of progression is defined as the earliest date that an overall tumour response of PD or death was recorded. For subjects who did not have a qualifying progressive disease or death, the date of censoring for PFS was the date when the last valid tumour assessment determined a lack of progression. The PFS assessed by the Investigator was analysed using the Kaplan-Meier method, and the median PFS based on non-CNS assessment is presented.

Outcome measures

Measure	Pilot Phase: FMX Then MM-398 n=13 Participants FMX phase: Subjects received a single bolus IV injection of 5 mg/kg FMX (up to 510 mg) on Day 1. Subjects underwent FMX-MRI scans and pre-MM-398 treatment biopsies on Days 1 to 4. MM-398 Treatment phase: Within 7 days of the FMX infusion, subjects received up to 70 mg/m\^2 MM-398 FBE (C1D1) administered as an IV infusion over 90 minutes, repeated every 2 weeks until disease progression, unacceptable toxicity or withdrawal of consent.	Expansion Phase: Cohort 2 n=10 Participants Subjects with TNBC. FMX phase: Subjects received an IV infusion of 5 mg/kg FMX (up to 510 mg) administered over a minimum of 15 minutes on Day 1. Subjects underwent FMX-MRI scans and a pre-MM-398 treatment biopsy on Days 1 to 2. MM-398 Treatment phase: Within 7 days of the FMX infusion, subjects received up to 70 mg/m\^2 MM-398 FBE (C1D1) administered as an IV infusion over 90 minutes, repeated every 2 weeks until disease progression, unacceptable toxicity or withdrawal of consent.	Expansion Phase: Cohort 3 n=9 Participants Subjects with BC with active brain metastasis. FMX phase: Subjects received an IV infusion of 5 mg/kg FMX (up to 510 mg) administered over a minimum of 15 minutes on Day 1. Subjects underwent FMX-MRI scans and a pre-MM-398 treatment biopsy on Days 1 to 2. MM-398 Treatment phase: Within 7 days of the FMX infusion, subjects received up to 70 mg/m\^2 MM-398 FBE (C1D1) administered as an IV infusion over 90 minutes, repeated every 2 weeks until disease progression, unacceptable toxicity or withdrawal of consent.	Expansion Phase: Cohort 3 n=10 Participants Subjects with BC with active brain metastasis. FMX phase: Subjects received an IV infusion of 5 mg/kg FMX (up to 510 mg) administered over a minimum of 15 minutes on Day 1. Subjects underwent FMX-MRI scans and a pre-MM-398 treatment biopsy on Days 1 to 2. MM-398 Treatment phase: Within 7 days of the FMX infusion, subjects received up to 70 mg/m\^2 MM-398 FBE (C1D1) administered as an IV infusion over 90 minutes, repeated every 2 weeks until disease progression, unacceptable toxicity or withdrawal of consent.
Pilot Phase + Expansion Phase: Median Progression-free Survival (PFS) (Non-CNS Assessment)	1.8 months Interval 1.0 to 3.6	1.9 months Interval 1.1 to 15.1	4.3 months Interval 1.0 to 9.4	3.2 months Interval 0.9 to 26.1

SECONDARY outcome

Timeframe: Baseline and every 8 weeks from C1D1 until disease progression, unacceptable toxicity or withdrawal of consent.

Population: The efficacy evaluable population consists of all subjects who received at least 1 dose of MM-398. Data is presented for Cohort 3 only which included subjects with brain metastasis, and who underwent CNS assessment using mRECIST criteria.

PFS was defined as the time in months from first dose of MM-398 to the date of radiologic disease progression by modified RECIST (mRECIST) criteria (CNS disease; Cohort 3) per Investigator assessment or death due to any cause, whichever occurred first.

The date of progression is defined as the earliest date that an overall tumour response of PD or death was recorded. For subjects who did not have a qualifying progressive disease or death, the date of censoring for PFS was the date when the last valid tumour assessment determined a lack of progression. The PFS assessed by the Investigator was analysed using the Kaplan-Meier method, and the median PFS based on CNS mRECIST assessment is provided for Cohort 3.

Outcome measures

Measure	Pilot Phase: FMX Then MM-398 n=10 Participants FMX phase: Subjects received a single bolus IV injection of 5 mg/kg FMX (up to 510 mg) on Day 1. Subjects underwent FMX-MRI scans and pre-MM-398 treatment biopsies on Days 1 to 4. MM-398 Treatment phase: Within 7 days of the FMX infusion, subjects received up to 70 mg/m\^2 MM-398 FBE (C1D1) administered as an IV infusion over 90 minutes, repeated every 2 weeks until disease progression, unacceptable toxicity or withdrawal of consent.	Expansion Phase: Cohort 2 Subjects with TNBC. FMX phase: Subjects received an IV infusion of 5 mg/kg FMX (up to 510 mg) administered over a minimum of 15 minutes on Day 1. Subjects underwent FMX-MRI scans and a pre-MM-398 treatment biopsy on Days 1 to 2. MM-398 Treatment phase: Within 7 days of the FMX infusion, subjects received up to 70 mg/m\^2 MM-398 FBE (C1D1) administered as an IV infusion over 90 minutes, repeated every 2 weeks until disease progression, unacceptable toxicity or withdrawal of consent.	Expansion Phase: Cohort 3 Subjects with BC with active brain metastasis. FMX phase: Subjects received an IV infusion of 5 mg/kg FMX (up to 510 mg) administered over a minimum of 15 minutes on Day 1. Subjects underwent FMX-MRI scans and a pre-MM-398 treatment biopsy on Days 1 to 2. MM-398 Treatment phase: Within 7 days of the FMX infusion, subjects received up to 70 mg/m\^2 MM-398 FBE (C1D1) administered as an IV infusion over 90 minutes, repeated every 2 weeks until disease progression, unacceptable toxicity or withdrawal of consent.	Expansion Phase: Cohort 3 Subjects with BC with active brain metastasis. FMX phase: Subjects received an IV infusion of 5 mg/kg FMX (up to 510 mg) administered over a minimum of 15 minutes on Day 1. Subjects underwent FMX-MRI scans and a pre-MM-398 treatment biopsy on Days 1 to 2. MM-398 Treatment phase: Within 7 days of the FMX infusion, subjects received up to 70 mg/m\^2 MM-398 FBE (C1D1) administered as an IV infusion over 90 minutes, repeated every 2 weeks until disease progression, unacceptable toxicity or withdrawal of consent.
Expansion Phase: Median PFS for Cohort 3 (CNS Assessment)	3.6 months Interval 0.9 to 9.6	—	—	—

SECONDARY outcome

Timeframe: Baseline and every 8 weeks from C1D1 until disease progression, unacceptable toxicity or withdrawal of consent.

Population: The efficacy evaluable population included all subjects who received at least 1 dose of MM-398.

BOR was defined as the best response by RECIST version 1.1 (Non-CNS assessments) criteria per Investigator assessment, recorded from the first dose of MM-398 until disease progression or the start of new anti-cancer therapy and/or surgery.

Tumour response was classified as CR, PR, SD or PD. Classification of SD required at least 1 assessment of SD at least 4 weeks after starting treatment. Subjects were categorised as not evaluable if there was insufficient data for response classification. The BOR is presented for non-CNS assessments for the Pilot phase and Cohorts 1 - 3.

Outcome measures

Measure	Pilot Phase: FMX Then MM-398 n=13 Participants FMX phase: Subjects received a single bolus IV injection of 5 mg/kg FMX (up to 510 mg) on Day 1. Subjects underwent FMX-MRI scans and pre-MM-398 treatment biopsies on Days 1 to 4. MM-398 Treatment phase: Within 7 days of the FMX infusion, subjects received up to 70 mg/m\^2 MM-398 FBE (C1D1) administered as an IV infusion over 90 minutes, repeated every 2 weeks until disease progression, unacceptable toxicity or withdrawal of consent.	Expansion Phase: Cohort 2 n=10 Participants Subjects with TNBC. FMX phase: Subjects received an IV infusion of 5 mg/kg FMX (up to 510 mg) administered over a minimum of 15 minutes on Day 1. Subjects underwent FMX-MRI scans and a pre-MM-398 treatment biopsy on Days 1 to 2. MM-398 Treatment phase: Within 7 days of the FMX infusion, subjects received up to 70 mg/m\^2 MM-398 FBE (C1D1) administered as an IV infusion over 90 minutes, repeated every 2 weeks until disease progression, unacceptable toxicity or withdrawal of consent.	Expansion Phase: Cohort 3 n=9 Participants Subjects with BC with active brain metastasis. FMX phase: Subjects received an IV infusion of 5 mg/kg FMX (up to 510 mg) administered over a minimum of 15 minutes on Day 1. Subjects underwent FMX-MRI scans and a pre-MM-398 treatment biopsy on Days 1 to 2. MM-398 Treatment phase: Within 7 days of the FMX infusion, subjects received up to 70 mg/m\^2 MM-398 FBE (C1D1) administered as an IV infusion over 90 minutes, repeated every 2 weeks until disease progression, unacceptable toxicity or withdrawal of consent.	Expansion Phase: Cohort 3 n=10 Participants Subjects with BC with active brain metastasis. FMX phase: Subjects received an IV infusion of 5 mg/kg FMX (up to 510 mg) administered over a minimum of 15 minutes on Day 1. Subjects underwent FMX-MRI scans and a pre-MM-398 treatment biopsy on Days 1 to 2. MM-398 Treatment phase: Within 7 days of the FMX infusion, subjects received up to 70 mg/m\^2 MM-398 FBE (C1D1) administered as an IV infusion over 90 minutes, repeated every 2 weeks until disease progression, unacceptable toxicity or withdrawal of consent.
Pilot Phase + Expansion Phase: BOR (Non-CNS Assessment) CR	0 Participants	0 Participants	0 Participants	0 Participants
Pilot Phase + Expansion Phase: BOR (Non-CNS Assessment) SD	5 Participants	0 Participants	3 Participants	2 Participants
Pilot Phase + Expansion Phase: BOR (Non-CNS Assessment) Non-CR/Non-PD	0 Participants	0 Participants	0 Participants	0 Participants
Pilot Phase + Expansion Phase: BOR (Non-CNS Assessment) PR	1 Participants	4 Participants	3 Participants	3 Participants
Pilot Phase + Expansion Phase: BOR (Non-CNS Assessment) PD	5 Participants	5 Participants	2 Participants	3 Participants
Pilot Phase + Expansion Phase: BOR (Non-CNS Assessment) Not evaluable	2 Participants	1 Participants	1 Participants	2 Participants

SECONDARY outcome

Timeframe: Baseline and every 8 weeks from C1D1 until disease progression, unacceptable toxicity or withdrawal of consent.

Population: The efficacy evaluable population included all subjects who received at least 1 dose of MM-398. Data is presented for Cohort 3 only which included subjects with brain metastasis, and who underwent CNS assessment using mRECIST criteria.

BOR was defined as the best response by mRECIST criteria (CNS disease; Cohort 3) criteria per Investigator assessment, recorded from the first dose of MM-398 until disease progression or the start of new anti-cancer therapy and/or surgery.

Tumour response was classified as CR, PR, SD or PD. Classification of SD required at least 1 assessment of SD at least 4 weeks after starting treatment. Subjects were categorised as not evaluable if there was insufficient data for response classification. The BOR is presented for CNS assessments for Cohort 3.

Outcome measures

Measure	Pilot Phase: FMX Then MM-398 n=10 Participants FMX phase: Subjects received a single bolus IV injection of 5 mg/kg FMX (up to 510 mg) on Day 1. Subjects underwent FMX-MRI scans and pre-MM-398 treatment biopsies on Days 1 to 4. MM-398 Treatment phase: Within 7 days of the FMX infusion, subjects received up to 70 mg/m\^2 MM-398 FBE (C1D1) administered as an IV infusion over 90 minutes, repeated every 2 weeks until disease progression, unacceptable toxicity or withdrawal of consent.	Expansion Phase: Cohort 2 Subjects with TNBC. FMX phase: Subjects received an IV infusion of 5 mg/kg FMX (up to 510 mg) administered over a minimum of 15 minutes on Day 1. Subjects underwent FMX-MRI scans and a pre-MM-398 treatment biopsy on Days 1 to 2. MM-398 Treatment phase: Within 7 days of the FMX infusion, subjects received up to 70 mg/m\^2 MM-398 FBE (C1D1) administered as an IV infusion over 90 minutes, repeated every 2 weeks until disease progression, unacceptable toxicity or withdrawal of consent.	Expansion Phase: Cohort 3 Subjects with BC with active brain metastasis. FMX phase: Subjects received an IV infusion of 5 mg/kg FMX (up to 510 mg) administered over a minimum of 15 minutes on Day 1. Subjects underwent FMX-MRI scans and a pre-MM-398 treatment biopsy on Days 1 to 2. MM-398 Treatment phase: Within 7 days of the FMX infusion, subjects received up to 70 mg/m\^2 MM-398 FBE (C1D1) administered as an IV infusion over 90 minutes, repeated every 2 weeks until disease progression, unacceptable toxicity or withdrawal of consent.	Expansion Phase: Cohort 3 Subjects with BC with active brain metastasis. FMX phase: Subjects received an IV infusion of 5 mg/kg FMX (up to 510 mg) administered over a minimum of 15 minutes on Day 1. Subjects underwent FMX-MRI scans and a pre-MM-398 treatment biopsy on Days 1 to 2. MM-398 Treatment phase: Within 7 days of the FMX infusion, subjects received up to 70 mg/m\^2 MM-398 FBE (C1D1) administered as an IV infusion over 90 minutes, repeated every 2 weeks until disease progression, unacceptable toxicity or withdrawal of consent.
Expansion Phase: BOR for Cohort 3 (CNS Assessment) PD	2 Participants	—	—	—
Expansion Phase: BOR for Cohort 3 (CNS Assessment) CR	0 Participants	—	—	—
Expansion Phase: BOR for Cohort 3 (CNS Assessment) PR	3 Participants	—	—	—
Expansion Phase: BOR for Cohort 3 (CNS Assessment) SD	3 Participants	—	—	—
Expansion Phase: BOR for Cohort 3 (CNS Assessment) Non-CR/Non-PD	0 Participants	—	—	—
Expansion Phase: BOR for Cohort 3 (CNS Assessment) Not evaluable	2 Participants	—	—	—

SECONDARY outcome

Timeframe: Baseline and every 8 weeks from C1D1 until disease progression, unacceptable toxicity or withdrawal of consent.

Population: The efficacy evaluable population included all subjects who received at least 1 dose of MM-398. Percentages are based on the number of subjects in the efficacy evaluable population in the corresponding phase/cohort.

The ORR was defined as the percentage of subjects with a BOR of either a CR or PR relative to the total number of evaluable subjects. Subjects with insufficient data for response classification were classified as non-responders for objective response. The ORR is presented for non-CNS assessments for the Pilot phase and Cohorts 1 - 3.

Outcome measures

Measure	Pilot Phase: FMX Then MM-398 n=13 Participants FMX phase: Subjects received a single bolus IV injection of 5 mg/kg FMX (up to 510 mg) on Day 1. Subjects underwent FMX-MRI scans and pre-MM-398 treatment biopsies on Days 1 to 4. MM-398 Treatment phase: Within 7 days of the FMX infusion, subjects received up to 70 mg/m\^2 MM-398 FBE (C1D1) administered as an IV infusion over 90 minutes, repeated every 2 weeks until disease progression, unacceptable toxicity or withdrawal of consent.	Expansion Phase: Cohort 2 n=10 Participants Subjects with TNBC. FMX phase: Subjects received an IV infusion of 5 mg/kg FMX (up to 510 mg) administered over a minimum of 15 minutes on Day 1. Subjects underwent FMX-MRI scans and a pre-MM-398 treatment biopsy on Days 1 to 2. MM-398 Treatment phase: Within 7 days of the FMX infusion, subjects received up to 70 mg/m\^2 MM-398 FBE (C1D1) administered as an IV infusion over 90 minutes, repeated every 2 weeks until disease progression, unacceptable toxicity or withdrawal of consent.	Expansion Phase: Cohort 3 n=9 Participants Subjects with BC with active brain metastasis. FMX phase: Subjects received an IV infusion of 5 mg/kg FMX (up to 510 mg) administered over a minimum of 15 minutes on Day 1. Subjects underwent FMX-MRI scans and a pre-MM-398 treatment biopsy on Days 1 to 2. MM-398 Treatment phase: Within 7 days of the FMX infusion, subjects received up to 70 mg/m\^2 MM-398 FBE (C1D1) administered as an IV infusion over 90 minutes, repeated every 2 weeks until disease progression, unacceptable toxicity or withdrawal of consent.	Expansion Phase: Cohort 3 n=10 Participants Subjects with BC with active brain metastasis. FMX phase: Subjects received an IV infusion of 5 mg/kg FMX (up to 510 mg) administered over a minimum of 15 minutes on Day 1. Subjects underwent FMX-MRI scans and a pre-MM-398 treatment biopsy on Days 1 to 2. MM-398 Treatment phase: Within 7 days of the FMX infusion, subjects received up to 70 mg/m\^2 MM-398 FBE (C1D1) administered as an IV infusion over 90 minutes, repeated every 2 weeks until disease progression, unacceptable toxicity or withdrawal of consent.
Pilot Phase + Expansion Phase: Objective Response Rate (ORR) (Non-CNS Assessment)	7.7 percentage of participants Interval 0.19 to 36.03	40.0 percentage of participants Interval 12.16 to 73.76	33.3 percentage of participants Interval 7.49 to 70.07	30.0 percentage of participants Interval 6.67 to 65.25

SECONDARY outcome

Timeframe: Baseline and every 8 weeks from C1D1 until disease progression, unacceptable toxicity or withdrawal of consent.

Population: The efficacy evaluable population included all subjects who received at least 1 dose of MM-398. Percentages are based on the number of subjects in the efficacy evaluable population in the corresponding phase/cohort. Data is presented for Cohort 3 which included subjects with brain metastasis, and who underwent CNS assessment using mRECIST criteria.

The ORR was defined as the percentage of subjects with a BOR of either a CR or PR relative to the total number of evaluable subjects. Subjects with insufficient data for response classification were classified as non-responders for objective response. The ORR is presented for CNS assessments for Cohort 3.

Outcome measures

Measure	Pilot Phase: FMX Then MM-398 n=10 Participants FMX phase: Subjects received a single bolus IV injection of 5 mg/kg FMX (up to 510 mg) on Day 1. Subjects underwent FMX-MRI scans and pre-MM-398 treatment biopsies on Days 1 to 4. MM-398 Treatment phase: Within 7 days of the FMX infusion, subjects received up to 70 mg/m\^2 MM-398 FBE (C1D1) administered as an IV infusion over 90 minutes, repeated every 2 weeks until disease progression, unacceptable toxicity or withdrawal of consent.	Expansion Phase: Cohort 2 Subjects with TNBC. FMX phase: Subjects received an IV infusion of 5 mg/kg FMX (up to 510 mg) administered over a minimum of 15 minutes on Day 1. Subjects underwent FMX-MRI scans and a pre-MM-398 treatment biopsy on Days 1 to 2. MM-398 Treatment phase: Within 7 days of the FMX infusion, subjects received up to 70 mg/m\^2 MM-398 FBE (C1D1) administered as an IV infusion over 90 minutes, repeated every 2 weeks until disease progression, unacceptable toxicity or withdrawal of consent.	Expansion Phase: Cohort 3 Subjects with BC with active brain metastasis. FMX phase: Subjects received an IV infusion of 5 mg/kg FMX (up to 510 mg) administered over a minimum of 15 minutes on Day 1. Subjects underwent FMX-MRI scans and a pre-MM-398 treatment biopsy on Days 1 to 2. MM-398 Treatment phase: Within 7 days of the FMX infusion, subjects received up to 70 mg/m\^2 MM-398 FBE (C1D1) administered as an IV infusion over 90 minutes, repeated every 2 weeks until disease progression, unacceptable toxicity or withdrawal of consent.	Expansion Phase: Cohort 3 Subjects with BC with active brain metastasis. FMX phase: Subjects received an IV infusion of 5 mg/kg FMX (up to 510 mg) administered over a minimum of 15 minutes on Day 1. Subjects underwent FMX-MRI scans and a pre-MM-398 treatment biopsy on Days 1 to 2. MM-398 Treatment phase: Within 7 days of the FMX infusion, subjects received up to 70 mg/m\^2 MM-398 FBE (C1D1) administered as an IV infusion over 90 minutes, repeated every 2 weeks until disease progression, unacceptable toxicity or withdrawal of consent.
Expansion Phase: ORR for Cohort 3 (CNS Assessment)	30.0 percentage of participants Interval 6.67 to 65.25	—	—	—

SECONDARY outcome

Timeframe: Baseline and every 8 weeks from C1D1 until disease progression, unacceptable toxicity or withdrawal of consent.

Population: The efficacy evaluable population included all subjects who received at least 1 dose of MM-398. Data is presented for the number of subjects who had a BOR classification of CR or PR.

DOR was defined as the time from first documentation of response (CR or PR whichever occurred first, based on Investigator assessment using RECIST criteria) to the date of disease progression or to death due to any cause, whichever occurred first. DOR was computed for subjects who had CR or PR as the BOR. For subjects who did not have a qualifying progressive disease or death, the date of censoring was the date when the last valid tumour assessment determined a lack of progression. The median DOR is presented for non-CNS assessments for the Pilot phase and Cohorts 1-3.

Outcome measures

Measure	Pilot Phase: FMX Then MM-398 n=1 Participants FMX phase: Subjects received a single bolus IV injection of 5 mg/kg FMX (up to 510 mg) on Day 1. Subjects underwent FMX-MRI scans and pre-MM-398 treatment biopsies on Days 1 to 4. MM-398 Treatment phase: Within 7 days of the FMX infusion, subjects received up to 70 mg/m\^2 MM-398 FBE (C1D1) administered as an IV infusion over 90 minutes, repeated every 2 weeks until disease progression, unacceptable toxicity or withdrawal of consent.	Expansion Phase: Cohort 2 n=4 Participants Subjects with TNBC. FMX phase: Subjects received an IV infusion of 5 mg/kg FMX (up to 510 mg) administered over a minimum of 15 minutes on Day 1. Subjects underwent FMX-MRI scans and a pre-MM-398 treatment biopsy on Days 1 to 2. MM-398 Treatment phase: Within 7 days of the FMX infusion, subjects received up to 70 mg/m\^2 MM-398 FBE (C1D1) administered as an IV infusion over 90 minutes, repeated every 2 weeks until disease progression, unacceptable toxicity or withdrawal of consent.	Expansion Phase: Cohort 3 n=3 Participants Subjects with BC with active brain metastasis. FMX phase: Subjects received an IV infusion of 5 mg/kg FMX (up to 510 mg) administered over a minimum of 15 minutes on Day 1. Subjects underwent FMX-MRI scans and a pre-MM-398 treatment biopsy on Days 1 to 2. MM-398 Treatment phase: Within 7 days of the FMX infusion, subjects received up to 70 mg/m\^2 MM-398 FBE (C1D1) administered as an IV infusion over 90 minutes, repeated every 2 weeks until disease progression, unacceptable toxicity or withdrawal of consent.	Expansion Phase: Cohort 3 n=3 Participants Subjects with BC with active brain metastasis. FMX phase: Subjects received an IV infusion of 5 mg/kg FMX (up to 510 mg) administered over a minimum of 15 minutes on Day 1. Subjects underwent FMX-MRI scans and a pre-MM-398 treatment biopsy on Days 1 to 2. MM-398 Treatment phase: Within 7 days of the FMX infusion, subjects received up to 70 mg/m\^2 MM-398 FBE (C1D1) administered as an IV infusion over 90 minutes, repeated every 2 weeks until disease progression, unacceptable toxicity or withdrawal of consent.
Pilot Phase + Expansion Phase: Median Duration of Objective Response (DOR) (Non-CNS Assessment)	3.84 months Interval 3.84 to 3.84	7.46 months Interval 6.4 to 13.0	5.62 months Interval 3.7 to 7.4	4.14 months Interval 0.0 to 22.2

SECONDARY outcome

Timeframe: Baseline and every 8 weeks from C1D1 until disease progression, unacceptable toxicity or withdrawal of consent.

Population: The efficacy evaluable population included all subjects who received at least 1 dose of MM-398. Data is presented for the number of subjects who had a BOR classification of CR or PR. Data is presented for Cohort 3 only which included subjects with brain metastasis, and who underwent CNS assessment using mRECIST criteria.

DOR was defined as the time from first documentation of response (CR or PR whichever occurred first, based on Investigator assessment using mRECIST criteria) to the date of disease progression or to death due to any cause, whichever occurred first. DOR was computed for subjects who had CR or PR as the BOR. For subjects who did not have a qualifying progressive disease or death, the date of censoring was the date when the last valid tumour assessment determined a lack of progression. The median DOR is presented for CNS assessments for Cohort 3.

Outcome measures

Measure	Pilot Phase: FMX Then MM-398 n=3 Participants FMX phase: Subjects received a single bolus IV injection of 5 mg/kg FMX (up to 510 mg) on Day 1. Subjects underwent FMX-MRI scans and pre-MM-398 treatment biopsies on Days 1 to 4. MM-398 Treatment phase: Within 7 days of the FMX infusion, subjects received up to 70 mg/m\^2 MM-398 FBE (C1D1) administered as an IV infusion over 90 minutes, repeated every 2 weeks until disease progression, unacceptable toxicity or withdrawal of consent.	Expansion Phase: Cohort 2 Subjects with TNBC. FMX phase: Subjects received an IV infusion of 5 mg/kg FMX (up to 510 mg) administered over a minimum of 15 minutes on Day 1. Subjects underwent FMX-MRI scans and a pre-MM-398 treatment biopsy on Days 1 to 2. MM-398 Treatment phase: Within 7 days of the FMX infusion, subjects received up to 70 mg/m\^2 MM-398 FBE (C1D1) administered as an IV infusion over 90 minutes, repeated every 2 weeks until disease progression, unacceptable toxicity or withdrawal of consent.	Expansion Phase: Cohort 3 Subjects with BC with active brain metastasis. FMX phase: Subjects received an IV infusion of 5 mg/kg FMX (up to 510 mg) administered over a minimum of 15 minutes on Day 1. Subjects underwent FMX-MRI scans and a pre-MM-398 treatment biopsy on Days 1 to 2. MM-398 Treatment phase: Within 7 days of the FMX infusion, subjects received up to 70 mg/m\^2 MM-398 FBE (C1D1) administered as an IV infusion over 90 minutes, repeated every 2 weeks until disease progression, unacceptable toxicity or withdrawal of consent.	Expansion Phase: Cohort 3 Subjects with BC with active brain metastasis. FMX phase: Subjects received an IV infusion of 5 mg/kg FMX (up to 510 mg) administered over a minimum of 15 minutes on Day 1. Subjects underwent FMX-MRI scans and a pre-MM-398 treatment biopsy on Days 1 to 2. MM-398 Treatment phase: Within 7 days of the FMX infusion, subjects received up to 70 mg/m\^2 MM-398 FBE (C1D1) administered as an IV infusion over 90 minutes, repeated every 2 weeks until disease progression, unacceptable toxicity or withdrawal of consent.
Expansion Phase: Median DOR for Cohort 3 (CNS Assessment)	1.84 months Interval 0.0 to 1.9	—	—	—

SECONDARY outcome

Timeframe: Baseline and every 8 weeks from C1D1 until disease progression, unacceptable toxicity or withdrawal of consent.

Population: The efficacy evaluable population included all subjects who received at least 1 dose of MM-398. Percentages are based on the number of subjects in the efficacy evaluable population in the corresponding phase/cohort.

CBR was defined as the percentage of subjects with a BOR characterised as a CR at any time, PR at any time, or SD ≥ 24 weeks relative to the total number of evaluable subjects. The CBR is presented for non-CNS assessments.

Outcome measures

Measure	Pilot Phase: FMX Then MM-398 n=13 Participants FMX phase: Subjects received a single bolus IV injection of 5 mg/kg FMX (up to 510 mg) on Day 1. Subjects underwent FMX-MRI scans and pre-MM-398 treatment biopsies on Days 1 to 4. MM-398 Treatment phase: Within 7 days of the FMX infusion, subjects received up to 70 mg/m\^2 MM-398 FBE (C1D1) administered as an IV infusion over 90 minutes, repeated every 2 weeks until disease progression, unacceptable toxicity or withdrawal of consent.	Expansion Phase: Cohort 2 n=10 Participants Subjects with TNBC. FMX phase: Subjects received an IV infusion of 5 mg/kg FMX (up to 510 mg) administered over a minimum of 15 minutes on Day 1. Subjects underwent FMX-MRI scans and a pre-MM-398 treatment biopsy on Days 1 to 2. MM-398 Treatment phase: Within 7 days of the FMX infusion, subjects received up to 70 mg/m\^2 MM-398 FBE (C1D1) administered as an IV infusion over 90 minutes, repeated every 2 weeks until disease progression, unacceptable toxicity or withdrawal of consent.	Expansion Phase: Cohort 3 n=9 Participants Subjects with BC with active brain metastasis. FMX phase: Subjects received an IV infusion of 5 mg/kg FMX (up to 510 mg) administered over a minimum of 15 minutes on Day 1. Subjects underwent FMX-MRI scans and a pre-MM-398 treatment biopsy on Days 1 to 2. MM-398 Treatment phase: Within 7 days of the FMX infusion, subjects received up to 70 mg/m\^2 MM-398 FBE (C1D1) administered as an IV infusion over 90 minutes, repeated every 2 weeks until disease progression, unacceptable toxicity or withdrawal of consent.	Expansion Phase: Cohort 3 n=10 Participants Subjects with BC with active brain metastasis. FMX phase: Subjects received an IV infusion of 5 mg/kg FMX (up to 510 mg) administered over a minimum of 15 minutes on Day 1. Subjects underwent FMX-MRI scans and a pre-MM-398 treatment biopsy on Days 1 to 2. MM-398 Treatment phase: Within 7 days of the FMX infusion, subjects received up to 70 mg/m\^2 MM-398 FBE (C1D1) administered as an IV infusion over 90 minutes, repeated every 2 weeks until disease progression, unacceptable toxicity or withdrawal of consent.
Pilot Phase + Expansion Phase: Clinical Benefit Response (CBR) (Non-CNS Assessment)	15.4 percentage of participants Interval 1.92 to 45.45	40.0 percentage of participants Interval 12.16 to 73.76	33.3 percentage of participants Interval 7.49 to 70.07	30.0 percentage of participants Interval 6.67 to 65.25

SECONDARY outcome

Timeframe: Baseline and every 8 weeks from C1D1 until disease progression, unacceptable toxicity or withdrawal of consent.

Population: The efficacy evaluable population included all subjects who received at least 1 dose of MM-398. Percentages are based on the number of subjects in the efficacy evaluable population in the corresponding phase/cohort. Data is presented for Cohort 3 which included subjects with brain metastasis, and who underwent CNS assessment using mRECIST criteria.

CBR was defined as the percentage of subjects with a BOR characterised as a CR at any time, PR at any time, or SD ≥ 24 weeks relative to the total number of evaluable subjects. The CBR is presented for CNS assessment for Cohort 3.

Outcome measures

Measure	Pilot Phase: FMX Then MM-398 n=10 Participants FMX phase: Subjects received a single bolus IV injection of 5 mg/kg FMX (up to 510 mg) on Day 1. Subjects underwent FMX-MRI scans and pre-MM-398 treatment biopsies on Days 1 to 4. MM-398 Treatment phase: Within 7 days of the FMX infusion, subjects received up to 70 mg/m\^2 MM-398 FBE (C1D1) administered as an IV infusion over 90 minutes, repeated every 2 weeks until disease progression, unacceptable toxicity or withdrawal of consent.	Expansion Phase: Cohort 2 Subjects with TNBC. FMX phase: Subjects received an IV infusion of 5 mg/kg FMX (up to 510 mg) administered over a minimum of 15 minutes on Day 1. Subjects underwent FMX-MRI scans and a pre-MM-398 treatment biopsy on Days 1 to 2. MM-398 Treatment phase: Within 7 days of the FMX infusion, subjects received up to 70 mg/m\^2 MM-398 FBE (C1D1) administered as an IV infusion over 90 minutes, repeated every 2 weeks until disease progression, unacceptable toxicity or withdrawal of consent.	Expansion Phase: Cohort 3 Subjects with BC with active brain metastasis. FMX phase: Subjects received an IV infusion of 5 mg/kg FMX (up to 510 mg) administered over a minimum of 15 minutes on Day 1. Subjects underwent FMX-MRI scans and a pre-MM-398 treatment biopsy on Days 1 to 2. MM-398 Treatment phase: Within 7 days of the FMX infusion, subjects received up to 70 mg/m\^2 MM-398 FBE (C1D1) administered as an IV infusion over 90 minutes, repeated every 2 weeks until disease progression, unacceptable toxicity or withdrawal of consent.	Expansion Phase: Cohort 3 Subjects with BC with active brain metastasis. FMX phase: Subjects received an IV infusion of 5 mg/kg FMX (up to 510 mg) administered over a minimum of 15 minutes on Day 1. Subjects underwent FMX-MRI scans and a pre-MM-398 treatment biopsy on Days 1 to 2. MM-398 Treatment phase: Within 7 days of the FMX infusion, subjects received up to 70 mg/m\^2 MM-398 FBE (C1D1) administered as an IV infusion over 90 minutes, repeated every 2 weeks until disease progression, unacceptable toxicity or withdrawal of consent.
Expansion Phase: CBR for Cohort 3 (CNS Assessment)	50.0 percentage of participants Interval 18.71 to 81.29	—	—	—

SECONDARY outcome

Timeframe: From MM-398 treatment start up to 30 days after last dose.

Population: The MM-398 safety population consisted of all subjects who received at least 1 dose of MM-398. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.

The number of subjects who experienced a TEAE reported to be related to MM-398 by the Investigator are presented for the Pilot and Expansion phases. An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing.

Outcome measures

Measure	Pilot Phase: FMX Then MM-398 n=13 Participants FMX phase: Subjects received a single bolus IV injection of 5 mg/kg FMX (up to 510 mg) on Day 1. Subjects underwent FMX-MRI scans and pre-MM-398 treatment biopsies on Days 1 to 4. MM-398 Treatment phase: Within 7 days of the FMX infusion, subjects received up to 70 mg/m\^2 MM-398 FBE (C1D1) administered as an IV infusion over 90 minutes, repeated every 2 weeks until disease progression, unacceptable toxicity or withdrawal of consent.	Expansion Phase: Cohort 2 n=29 Participants Subjects with TNBC. FMX phase: Subjects received an IV infusion of 5 mg/kg FMX (up to 510 mg) administered over a minimum of 15 minutes on Day 1. Subjects underwent FMX-MRI scans and a pre-MM-398 treatment biopsy on Days 1 to 2. MM-398 Treatment phase: Within 7 days of the FMX infusion, subjects received up to 70 mg/m\^2 MM-398 FBE (C1D1) administered as an IV infusion over 90 minutes, repeated every 2 weeks until disease progression, unacceptable toxicity or withdrawal of consent.	Expansion Phase: Cohort 3 Subjects with BC with active brain metastasis. FMX phase: Subjects received an IV infusion of 5 mg/kg FMX (up to 510 mg) administered over a minimum of 15 minutes on Day 1. Subjects underwent FMX-MRI scans and a pre-MM-398 treatment biopsy on Days 1 to 2. MM-398 Treatment phase: Within 7 days of the FMX infusion, subjects received up to 70 mg/m\^2 MM-398 FBE (C1D1) administered as an IV infusion over 90 minutes, repeated every 2 weeks until disease progression, unacceptable toxicity or withdrawal of consent.	Expansion Phase: Cohort 3 Subjects with BC with active brain metastasis. FMX phase: Subjects received an IV infusion of 5 mg/kg FMX (up to 510 mg) administered over a minimum of 15 minutes on Day 1. Subjects underwent FMX-MRI scans and a pre-MM-398 treatment biopsy on Days 1 to 2. MM-398 Treatment phase: Within 7 days of the FMX infusion, subjects received up to 70 mg/m\^2 MM-398 FBE (C1D1) administered as an IV infusion over 90 minutes, repeated every 2 weeks until disease progression, unacceptable toxicity or withdrawal of consent.
Pilot Phase + Expansion Phase: Number of Subjects Who Experienced Treatment Emergent Adverse Events (TEAEs) Related to MM-398	13 participants	28 participants	—	—

SECONDARY outcome

Timeframe: Pilot phase: C1D1 pre-MM-398 infusion, end of infusion, post-infusion (2, 72, 168 hours); C1D15 pre-infusion; 30 days follow-up visit.

Population: The PK set included subjects who received at least 1 dose of MM-398, blood samples were collected at the predefined points (with no major protocol deviations affecting PK variables \& sufficient number of plasma concentrations to estimate main PK parameters \[Cmax, AUC\]); analysis was within the sample stability period to estimate main PK parameters.

In Cycle 1 only of the Pilot phase, samples were collected to determine the levels of total irinotecan (liposomal and free drug) and SN-38 (metabolite) in plasma following a dose of 70 mg/m^2 MM-398 FBE (80 mg/m^2 MM-398 salt-base equivalent [SBE]). The pharmacokinetic (PK) analysis was based on non-compartmental analysis. Any plasma concentrations below the lower limit of quantification (LLOQ) were assigned as missing/zero in the data set according to predetermined rules. The LLOQ for irinotecan was 0.140 micrograms per millilitre (mcg/mL), and for SN-38 the LLOQ for the Pilot phase was 0.441 nanograms per millilitre (ng/mL). The median tmax is presented for the Pilot phase.

Outcome measures

Measure	Pilot Phase: FMX Then MM-398 n=13 Participants FMX phase: Subjects received a single bolus IV injection of 5 mg/kg FMX (up to 510 mg) on Day 1. Subjects underwent FMX-MRI scans and pre-MM-398 treatment biopsies on Days 1 to 4. MM-398 Treatment phase: Within 7 days of the FMX infusion, subjects received up to 70 mg/m\^2 MM-398 FBE (C1D1) administered as an IV infusion over 90 minutes, repeated every 2 weeks until disease progression, unacceptable toxicity or withdrawal of consent.	Expansion Phase: Cohort 2 Subjects with TNBC. FMX phase: Subjects received an IV infusion of 5 mg/kg FMX (up to 510 mg) administered over a minimum of 15 minutes on Day 1. Subjects underwent FMX-MRI scans and a pre-MM-398 treatment biopsy on Days 1 to 2. MM-398 Treatment phase: Within 7 days of the FMX infusion, subjects received up to 70 mg/m\^2 MM-398 FBE (C1D1) administered as an IV infusion over 90 minutes, repeated every 2 weeks until disease progression, unacceptable toxicity or withdrawal of consent.	Expansion Phase: Cohort 3 Subjects with BC with active brain metastasis. FMX phase: Subjects received an IV infusion of 5 mg/kg FMX (up to 510 mg) administered over a minimum of 15 minutes on Day 1. Subjects underwent FMX-MRI scans and a pre-MM-398 treatment biopsy on Days 1 to 2. MM-398 Treatment phase: Within 7 days of the FMX infusion, subjects received up to 70 mg/m\^2 MM-398 FBE (C1D1) administered as an IV infusion over 90 minutes, repeated every 2 weeks until disease progression, unacceptable toxicity or withdrawal of consent.	Expansion Phase: Cohort 3 Subjects with BC with active brain metastasis. FMX phase: Subjects received an IV infusion of 5 mg/kg FMX (up to 510 mg) administered over a minimum of 15 minutes on Day 1. Subjects underwent FMX-MRI scans and a pre-MM-398 treatment biopsy on Days 1 to 2. MM-398 Treatment phase: Within 7 days of the FMX infusion, subjects received up to 70 mg/m\^2 MM-398 FBE (C1D1) administered as an IV infusion over 90 minutes, repeated every 2 weeks until disease progression, unacceptable toxicity or withdrawal of consent.
Pilot Phase: Time to Reach Maximum Plasma Concentration of Irinotecan and SN-38 (Tmax) Irinotecan	1.72 hours Interval 1.52 to 3.2	—	—	—
Pilot Phase: Time to Reach Maximum Plasma Concentration of Irinotecan and SN-38 (Tmax) SN-38	3.20 hours Interval 1.65 to 75.22	—	—	—

SECONDARY outcome

Timeframe: Expansion phase: Cycles 1-3 pre-MM-398 infusion, end of infusion, post-infusion (2, 48,168 hours); D15 pre-infusion; 30 days follow-up visit.

Population: The PK set included subjects who received at least 1 dose of MM-398, blood samples were collected at the predefined points (with no major protocol deviations affecting PK variables \& sufficient number of plasma concentrations to estimate main PK parameters \[Cmax, AUC\]); analysis was within the sample stability period to estimate main PK parameters.

For the Expansion phase, samples were collected to determine the levels of total irinotecan (liposomal and free drug) and SN-38 (metabolite) in plasma and data is presented for Cycles 1 to 3 by dose received for each cycle (depending on dose titration): 35 to 70 mg/m^2 MM-398 FBE (40 to 80 mg/m^2 MM-398 SBE). The PK analysis was based on non-compartmental analysis. Any plasma concentrations below the LLOQ were assigned as missing/zero in the data set according to predetermined rules. The LLOQ for irinotecan was 0.140 mcg/mL and for SN-38 the LLOQ for the Expansion phase was 0.600 ng/mL. The median tmax is presented for dose levels in the Expansion phase for which data was collected. PK results for subjects in all cohorts of the Expansion Phase were combined for those on the same cycle and at the same dose. The total number of subjects evaluated in the PK set for the Expansion Phase was 21, with different numbers evaluated for each cycle/dose.

Outcome measures

Measure	Pilot Phase: FMX Then MM-398 n=21 Participants FMX phase: Subjects received a single bolus IV injection of 5 mg/kg FMX (up to 510 mg) on Day 1. Subjects underwent FMX-MRI scans and pre-MM-398 treatment biopsies on Days 1 to 4. MM-398 Treatment phase: Within 7 days of the FMX infusion, subjects received up to 70 mg/m\^2 MM-398 FBE (C1D1) administered as an IV infusion over 90 minutes, repeated every 2 weeks until disease progression, unacceptable toxicity or withdrawal of consent.	Expansion Phase: Cohort 2 Subjects with TNBC. FMX phase: Subjects received an IV infusion of 5 mg/kg FMX (up to 510 mg) administered over a minimum of 15 minutes on Day 1. Subjects underwent FMX-MRI scans and a pre-MM-398 treatment biopsy on Days 1 to 2. MM-398 Treatment phase: Within 7 days of the FMX infusion, subjects received up to 70 mg/m\^2 MM-398 FBE (C1D1) administered as an IV infusion over 90 minutes, repeated every 2 weeks until disease progression, unacceptable toxicity or withdrawal of consent.	Expansion Phase: Cohort 3 Subjects with BC with active brain metastasis. FMX phase: Subjects received an IV infusion of 5 mg/kg FMX (up to 510 mg) administered over a minimum of 15 minutes on Day 1. Subjects underwent FMX-MRI scans and a pre-MM-398 treatment biopsy on Days 1 to 2. MM-398 Treatment phase: Within 7 days of the FMX infusion, subjects received up to 70 mg/m\^2 MM-398 FBE (C1D1) administered as an IV infusion over 90 minutes, repeated every 2 weeks until disease progression, unacceptable toxicity or withdrawal of consent.	Expansion Phase: Cohort 3 Subjects with BC with active brain metastasis. FMX phase: Subjects received an IV infusion of 5 mg/kg FMX (up to 510 mg) administered over a minimum of 15 minutes on Day 1. Subjects underwent FMX-MRI scans and a pre-MM-398 treatment biopsy on Days 1 to 2. MM-398 Treatment phase: Within 7 days of the FMX infusion, subjects received up to 70 mg/m\^2 MM-398 FBE (C1D1) administered as an IV infusion over 90 minutes, repeated every 2 weeks until disease progression, unacceptable toxicity or withdrawal of consent.
Expansion Phase: Irinotecan and SN-38 Tmax Irinotecan: Cycle 1 40 mg/m^2 SBE	NA hours Interval 3.88 to 3.88 Descriptive statistics could not be determined for this sample size and therefore the median value was not calculated.	—	—	—
Expansion Phase: Irinotecan and SN-38 Tmax Irinotecan: Cycle 1 60 mg/m^2 SBE	1.71 hours Interval 1.52 to 3.67	—	—	—
Expansion Phase: Irinotecan and SN-38 Tmax Irinotecan: Cycle 1 80 mg/m^2 SBE	1.73 hours Interval 1.63 to 1.8	—	—	—
Expansion Phase: Irinotecan and SN-38 Tmax Irinotecan: Cycle 2 40 mg/m^2 SBE	NA hours Interval 1.98 to 1.98 Descriptive statistics could not be determined for this sample size and therefore the median value was not calculated.	—	—	—
Expansion Phase: Irinotecan and SN-38 Tmax Irinotecan: Cycle 2 60 mg/m^2 SBE	3.03 hours Interval 1.58 to 3.62	—	—	—
Expansion Phase: Irinotecan and SN-38 Tmax Irinotecan: Cycle 2 80 mg/m^2 SBE	2.12 hours Interval 1.7 to 3.55	—	—	—
Expansion Phase: Irinotecan and SN-38 Tmax Irinotecan: Cycle 3 40 mg/m^2 SBE	NA hours Interval 1.68 to 2.5 Descriptive statistics could not be determined for this sample size and therefore the median value was not calculated.	—	—	—
Expansion Phase: Irinotecan and SN-38 Tmax Irinotecan: Cycle 3 60 mg/m^2 SBE	3.26 hours Interval 1.63 to 48.33	—	—	—
Expansion Phase: Irinotecan and SN-38 Tmax Irinotecan: Cycle 3 80 mg/m^2 SBE	2.47 hours Interval 1.5 to 6.92	—	—	—
Expansion Phase: Irinotecan and SN-38 Tmax SN-38: Cycle 1 60 mg/m^2 SBE	3.08 hours Interval 1.57 to 40.82	—	—	—
Expansion Phase: Irinotecan and SN-38 Tmax SN-38: Cycle 2 60 mg/m^2 SBE	25.88 hours Interval 3.08 to 67.42	—	—	—
Expansion Phase: Irinotecan and SN-38 Tmax SN-38: Cycle 2 80 mg/m^2 SBE	NA hours Interval 1.7 to 1.7 Descriptive statistics could not be determined for this sample size and therefore the median value was not calculated.	—	—	—
Expansion Phase: Irinotecan and SN-38 Tmax SN-38: Cycle 3 60 mg/m^2 SBE	31.29 hours Interval 1.65 to 44.95	—	—	—
Expansion Phase: Irinotecan and SN-38 Tmax SN-38: Cycle 3 80 mg/m^2 SBE	NA hours Interval 3.27 to 3.27 Descriptive statistics could not be determined for this sample size and therefore the median value was not calculated.	—	—	—

SECONDARY outcome

Timeframe: Pilot phase: C1D1 pre-MM-398 infusion, end of infusion, post-infusion (2, 72, 168 hours); C1D15 pre-infusion; 30 days follow-up visit.

Population: The PK set included subjects who received at least 1 dose of MM-398, blood samples were collected at the predefined points (with no major protocol deviations affecting PK variables \& sufficient number of plasma concentrations to estimate main PK parameters \[Cmax, AUC\]); analysis was within the sample stability period to estimate main PK parameters.

In Cycle 1 only of the Pilot phase, samples were collected to determine the levels of total irinotecan (liposomal and free drug) in plasma following a dose of 70 mg/m^2 MM-398 FBE (80 mg/m^2 MM-398 SBE). The PK analysis was based on non-compartmental analysis. Any plasma concentrations below the LLOQ were assigned as missing/zero in the data set according to predetermined rules. The LLOQ for irinotecan was 0.140 mcg/mL. The mean Cmax is presented for the Pilot phase.

Outcome measures

Measure	Pilot Phase: FMX Then MM-398 n=13 Participants FMX phase: Subjects received a single bolus IV injection of 5 mg/kg FMX (up to 510 mg) on Day 1. Subjects underwent FMX-MRI scans and pre-MM-398 treatment biopsies on Days 1 to 4. MM-398 Treatment phase: Within 7 days of the FMX infusion, subjects received up to 70 mg/m\^2 MM-398 FBE (C1D1) administered as an IV infusion over 90 minutes, repeated every 2 weeks until disease progression, unacceptable toxicity or withdrawal of consent.	Expansion Phase: Cohort 2 Subjects with TNBC. FMX phase: Subjects received an IV infusion of 5 mg/kg FMX (up to 510 mg) administered over a minimum of 15 minutes on Day 1. Subjects underwent FMX-MRI scans and a pre-MM-398 treatment biopsy on Days 1 to 2. MM-398 Treatment phase: Within 7 days of the FMX infusion, subjects received up to 70 mg/m\^2 MM-398 FBE (C1D1) administered as an IV infusion over 90 minutes, repeated every 2 weeks until disease progression, unacceptable toxicity or withdrawal of consent.	Expansion Phase: Cohort 3 Subjects with BC with active brain metastasis. FMX phase: Subjects received an IV infusion of 5 mg/kg FMX (up to 510 mg) administered over a minimum of 15 minutes on Day 1. Subjects underwent FMX-MRI scans and a pre-MM-398 treatment biopsy on Days 1 to 2. MM-398 Treatment phase: Within 7 days of the FMX infusion, subjects received up to 70 mg/m\^2 MM-398 FBE (C1D1) administered as an IV infusion over 90 minutes, repeated every 2 weeks until disease progression, unacceptable toxicity or withdrawal of consent.	Expansion Phase: Cohort 3 Subjects with BC with active brain metastasis. FMX phase: Subjects received an IV infusion of 5 mg/kg FMX (up to 510 mg) administered over a minimum of 15 minutes on Day 1. Subjects underwent FMX-MRI scans and a pre-MM-398 treatment biopsy on Days 1 to 2. MM-398 Treatment phase: Within 7 days of the FMX infusion, subjects received up to 70 mg/m\^2 MM-398 FBE (C1D1) administered as an IV infusion over 90 minutes, repeated every 2 weeks until disease progression, unacceptable toxicity or withdrawal of consent.
Pilot Phase: Maximum Observed Plasma Concentration of Irinotecan (Cmax)	39.0 mcg/mL Interval 20.4 to 47.1	—	—	—

SECONDARY outcome

Timeframe: Pilot phase: C1D1 pre-MM-398 infusion, end of infusion, post-infusion (2, 72, 168 hours); C1D15 pre-infusion; 30 days follow-up visit.

Population: The PK set included subjects who received at least 1 dose of MM-398, blood samples were collected at the predefined points (with no major protocol deviations affecting PK variables \& sufficient number of plasma concentrations to estimate main PK parameters \[Cmax, AUC\]); analysis was within the sample stability period to estimate main PK parameters.

In Cycle 1 only of the Pilot phase, samples were collected to determine the levels of SN-38 (metabolite) in plasma following a dose of 70 mg/m^2 MM-398 FBE (80 mg/m^2 MM-398 SBE). The PK analysis was based on non-compartmental analysis. Any plasma concentrations below the LLOQ were assigned as missing/zero in the data set according to predetermined rules. The LLOQ for SN-38 for the Pilot phase was 0.441 ng/mL. The mean Cmax is presented for the Pilot phase.

Outcome measures

Measure	Pilot Phase: FMX Then MM-398 n=13 Participants FMX phase: Subjects received a single bolus IV injection of 5 mg/kg FMX (up to 510 mg) on Day 1. Subjects underwent FMX-MRI scans and pre-MM-398 treatment biopsies on Days 1 to 4. MM-398 Treatment phase: Within 7 days of the FMX infusion, subjects received up to 70 mg/m\^2 MM-398 FBE (C1D1) administered as an IV infusion over 90 minutes, repeated every 2 weeks until disease progression, unacceptable toxicity or withdrawal of consent.	Expansion Phase: Cohort 2 Subjects with TNBC. FMX phase: Subjects received an IV infusion of 5 mg/kg FMX (up to 510 mg) administered over a minimum of 15 minutes on Day 1. Subjects underwent FMX-MRI scans and a pre-MM-398 treatment biopsy on Days 1 to 2. MM-398 Treatment phase: Within 7 days of the FMX infusion, subjects received up to 70 mg/m\^2 MM-398 FBE (C1D1) administered as an IV infusion over 90 minutes, repeated every 2 weeks until disease progression, unacceptable toxicity or withdrawal of consent.	Expansion Phase: Cohort 3 Subjects with BC with active brain metastasis. FMX phase: Subjects received an IV infusion of 5 mg/kg FMX (up to 510 mg) administered over a minimum of 15 minutes on Day 1. Subjects underwent FMX-MRI scans and a pre-MM-398 treatment biopsy on Days 1 to 2. MM-398 Treatment phase: Within 7 days of the FMX infusion, subjects received up to 70 mg/m\^2 MM-398 FBE (C1D1) administered as an IV infusion over 90 minutes, repeated every 2 weeks until disease progression, unacceptable toxicity or withdrawal of consent.	Expansion Phase: Cohort 3 Subjects with BC with active brain metastasis. FMX phase: Subjects received an IV infusion of 5 mg/kg FMX (up to 510 mg) administered over a minimum of 15 minutes on Day 1. Subjects underwent FMX-MRI scans and a pre-MM-398 treatment biopsy on Days 1 to 2. MM-398 Treatment phase: Within 7 days of the FMX infusion, subjects received up to 70 mg/m\^2 MM-398 FBE (C1D1) administered as an IV infusion over 90 minutes, repeated every 2 weeks until disease progression, unacceptable toxicity or withdrawal of consent.
Pilot Phase: SN-38 Cmax	2.40 ng/mL Interval 1.52 to 3.62	—	—	—

SECONDARY outcome

Timeframe: Expansion phase: Cycles 1-3 pre-MM-398 infusion, end of infusion, post-infusion (2, 48,168 hours); D15 pre-infusion; 30 days follow-up visit.

Population: The PK set included subjects who received at least 1 dose of MM-398, blood samples were collected at the predefined points (with no major protocol deviations affecting PK variables \& sufficient number of plasma concentrations to estimate main PK parameters \[Cmax, AUC\]); analysis was within the sample stability period to estimate main PK parameters.

For the Expansion phase, samples were collected to determine the levels of total irinotecan (liposomal and free drug) in plasma and data is presented for Cycles 1 to 3 by dose received for each cycle (depending on dose titration): 35 to 70 mg/m^2 MM-398 FBE (40 to 80 mg/m^2 MM-398 SBE). The PK analysis was based on non-compartmental analysis. Any plasma concentrations below the LLOQ were assigned as missing/zero in the data set according to predetermined rules. The LLOQ for irinotecan was 0.140 mcg/mL. The mean Cmax is presented for the Expansion phase. PK results for subjects in all cohorts of the Expansion Phase were combined for those on the same cycle and at the same dose. The total number of subjects evaluated in the PK set for the Expansion Phase was 21, with different numbers evaluated for each cycle/dose.

Outcome measures

Measure	Pilot Phase: FMX Then MM-398 n=21 Participants FMX phase: Subjects received a single bolus IV injection of 5 mg/kg FMX (up to 510 mg) on Day 1. Subjects underwent FMX-MRI scans and pre-MM-398 treatment biopsies on Days 1 to 4. MM-398 Treatment phase: Within 7 days of the FMX infusion, subjects received up to 70 mg/m\^2 MM-398 FBE (C1D1) administered as an IV infusion over 90 minutes, repeated every 2 weeks until disease progression, unacceptable toxicity or withdrawal of consent.	Expansion Phase: Cohort 2 Subjects with TNBC. FMX phase: Subjects received an IV infusion of 5 mg/kg FMX (up to 510 mg) administered over a minimum of 15 minutes on Day 1. Subjects underwent FMX-MRI scans and a pre-MM-398 treatment biopsy on Days 1 to 2. MM-398 Treatment phase: Within 7 days of the FMX infusion, subjects received up to 70 mg/m\^2 MM-398 FBE (C1D1) administered as an IV infusion over 90 minutes, repeated every 2 weeks until disease progression, unacceptable toxicity or withdrawal of consent.	Expansion Phase: Cohort 3 Subjects with BC with active brain metastasis. FMX phase: Subjects received an IV infusion of 5 mg/kg FMX (up to 510 mg) administered over a minimum of 15 minutes on Day 1. Subjects underwent FMX-MRI scans and a pre-MM-398 treatment biopsy on Days 1 to 2. MM-398 Treatment phase: Within 7 days of the FMX infusion, subjects received up to 70 mg/m\^2 MM-398 FBE (C1D1) administered as an IV infusion over 90 minutes, repeated every 2 weeks until disease progression, unacceptable toxicity or withdrawal of consent.	Expansion Phase: Cohort 3 Subjects with BC with active brain metastasis. FMX phase: Subjects received an IV infusion of 5 mg/kg FMX (up to 510 mg) administered over a minimum of 15 minutes on Day 1. Subjects underwent FMX-MRI scans and a pre-MM-398 treatment biopsy on Days 1 to 2. MM-398 Treatment phase: Within 7 days of the FMX infusion, subjects received up to 70 mg/m\^2 MM-398 FBE (C1D1) administered as an IV infusion over 90 minutes, repeated every 2 weeks until disease progression, unacceptable toxicity or withdrawal of consent.
Expansion Phase: Irinotecan Cmax Cycle 1 60 mg/m^2 SBE	28.1 mcg/mL Interval 20.8 to 40.4	—	—	—
Expansion Phase: Irinotecan Cmax Cycle 1 40 mg/m^2 SBE	NA mcg/mL Interval 21.7 to 21.7 Descriptive statistics could not be determined for this sample size and therefore the mean value was not calculated.	—	—	—
Expansion Phase: Irinotecan Cmax Cycle 1 80 mg/m^2 SBE	44.4 mcg/mL Interval 34.2 to 56.4	—	—	—
Expansion Phase: Irinotecan Cmax Cycle 2 40 mg/m^2 SBE	NA mcg/mL Interval 22.1 to 22.1 Descriptive statistics could not be determined for this sample size and therefore the mean value was not calculated.	—	—	—
Expansion Phase: Irinotecan Cmax Cycle 2 60 mg/m^2 SBE	30.4 mcg/mL Interval 15.7 to 37.3	—	—	—
Expansion Phase: Irinotecan Cmax Cycle 2 80 mg/m^2 SBE	46.6 mcg/mL Interval 34.2 to 55.8	—	—	—
Expansion Phase: Irinotecan Cmax Cycle 3 40 mg/m^2 SBE	NA mcg/mL Interval 18.3 to 19.9 Descriptive statistics could not be determined for this sample size and therefore the mean value was not calculated.	—	—	—
Expansion Phase: Irinotecan Cmax Cycle 3 60 mg/m^2 SBE	30.3 mcg/mL Interval 17.5 to 40.8	—	—	—
Expansion Phase: Irinotecan Cmax Cycle 3 80 mg/m^2 SBE	45.8 mcg/mL Interval 38.6 to 51.5	—	—	—

SECONDARY outcome

Timeframe: Expansion phase: Cycles 1-3 pre-MM-398 infusion, end of infusion, post-infusion (2, 48,168 hours); D15 pre-infusion; 30 days follow-up visit.

Population: The PK set included subjects who received at least 1 dose of MM-398, blood samples were collected at the predefined points (with no major protocol deviations affecting PK variables \& sufficient number of plasma concentrations to estimate main PK parameters \[Cmax, AUC\]); analysis was within the sample stability period to estimate main PK parameters.

For the Expansion phase, samples were collected to determine the levels of SN-38 (metabolite) in plasma and data is presented for Cycles 1 to 3 by dose received for each cycle (depending on dose titration): 35 to 70 mg/m^2 MM-398 FBE (40 to 80 mg/m^2 MM-398 SBE). The PK analysis was based on non-compartmental analysis. Any plasma concentrations below the LLOQ were assigned as missing/zero in the data set according to predetermined rules. The LLOQ for SN-38 for the Expansion phase was 0.600 ng/mL. The mean Cmax is presented for dose levels in the Expansion phase for which data was collected. PK results for subjects in all cohorts of the Expansion Phase were combined for those on the same cycle and at the same dose. The total number of subjects evaluated in the PK set for the Expansion Phase was 21, with different numbers evaluated for each cycle/dose.

Outcome measures

Measure	Pilot Phase: FMX Then MM-398 n=21 Participants FMX phase: Subjects received a single bolus IV injection of 5 mg/kg FMX (up to 510 mg) on Day 1. Subjects underwent FMX-MRI scans and pre-MM-398 treatment biopsies on Days 1 to 4. MM-398 Treatment phase: Within 7 days of the FMX infusion, subjects received up to 70 mg/m\^2 MM-398 FBE (C1D1) administered as an IV infusion over 90 minutes, repeated every 2 weeks until disease progression, unacceptable toxicity or withdrawal of consent.	Expansion Phase: Cohort 2 Subjects with TNBC. FMX phase: Subjects received an IV infusion of 5 mg/kg FMX (up to 510 mg) administered over a minimum of 15 minutes on Day 1. Subjects underwent FMX-MRI scans and a pre-MM-398 treatment biopsy on Days 1 to 2. MM-398 Treatment phase: Within 7 days of the FMX infusion, subjects received up to 70 mg/m\^2 MM-398 FBE (C1D1) administered as an IV infusion over 90 minutes, repeated every 2 weeks until disease progression, unacceptable toxicity or withdrawal of consent.	Expansion Phase: Cohort 3 Subjects with BC with active brain metastasis. FMX phase: Subjects received an IV infusion of 5 mg/kg FMX (up to 510 mg) administered over a minimum of 15 minutes on Day 1. Subjects underwent FMX-MRI scans and a pre-MM-398 treatment biopsy on Days 1 to 2. MM-398 Treatment phase: Within 7 days of the FMX infusion, subjects received up to 70 mg/m\^2 MM-398 FBE (C1D1) administered as an IV infusion over 90 minutes, repeated every 2 weeks until disease progression, unacceptable toxicity or withdrawal of consent.	Expansion Phase: Cohort 3 Subjects with BC with active brain metastasis. FMX phase: Subjects received an IV infusion of 5 mg/kg FMX (up to 510 mg) administered over a minimum of 15 minutes on Day 1. Subjects underwent FMX-MRI scans and a pre-MM-398 treatment biopsy on Days 1 to 2. MM-398 Treatment phase: Within 7 days of the FMX infusion, subjects received up to 70 mg/m\^2 MM-398 FBE (C1D1) administered as an IV infusion over 90 minutes, repeated every 2 weeks until disease progression, unacceptable toxicity or withdrawal of consent.
Expansion Phase: SN-38 Cmax Cycle 1 60 mg/m^2 SBE	3.08 ng/mL Interval 2.01 to 5.23	—	—	—
Expansion Phase: SN-38 Cmax Cycle 2 60 mg/m^2 SBE	3.63 ng/mL Interval 1.74 to 7.62	—	—	—
Expansion Phase: SN-38 Cmax Cycle 2 80 mg/m^2 SBE	NA ng/mL Interval 4.14 to 4.14 Descriptive statistics could not be determined for this sample size and therefore the mean value was not calculated.	—	—	—
Expansion Phase: SN-38 Cmax Cycle 3 60 mg/m^2 SBE	2.60 ng/mL Interval 1.03 to 3.55	—	—	—
Expansion Phase: SN-38 Cmax Cycle 3 80 mg/m^2 SBE	NA ng/mL Interval 3.08 to 3.08 Descriptive statistics could not be determined for this sample size and therefore the mean value was not calculated.	—	—	—

SECONDARY outcome

Timeframe: Pilot phase: C1D1 pre-MM-398 infusion, end of infusion, post-infusion (2, 72, 168 hours); C1D15 pre-infusion; 30 days follow-up visit.

Population: The PK set included subjects who received at least 1 dose of MM-398, blood samples were collected at the predefined points (with no major protocol deviations affecting PK variables \& sufficient number of plasma concentrations to estimate main PK parameters \[Cmax, AUC\]); analysis was within the sample stability period to estimate main PK parameters.

In Cycle 1 only of the Pilot phase, samples were collected to determine the levels of total irinotecan (liposomal and free drug) in plasma following a dose of 70 mg/m^2 MM-398 FBE (80 mg/m^2 MM-398 SBE). The PK analysis was based on non-compartmental analysis. Any plasma concentrations below the LLOQ were assigned as missing/zero in the data set according to predetermined rules. The LLOQ for irinotecan was 0.140 mcg/mL. The mean AUC(0-tlast) is presented for the Pilot phase.

Outcome measures

Measure	Pilot Phase: FMX Then MM-398 n=13 Participants FMX phase: Subjects received a single bolus IV injection of 5 mg/kg FMX (up to 510 mg) on Day 1. Subjects underwent FMX-MRI scans and pre-MM-398 treatment biopsies on Days 1 to 4. MM-398 Treatment phase: Within 7 days of the FMX infusion, subjects received up to 70 mg/m\^2 MM-398 FBE (C1D1) administered as an IV infusion over 90 minutes, repeated every 2 weeks until disease progression, unacceptable toxicity or withdrawal of consent.	Expansion Phase: Cohort 2 Subjects with TNBC. FMX phase: Subjects received an IV infusion of 5 mg/kg FMX (up to 510 mg) administered over a minimum of 15 minutes on Day 1. Subjects underwent FMX-MRI scans and a pre-MM-398 treatment biopsy on Days 1 to 2. MM-398 Treatment phase: Within 7 days of the FMX infusion, subjects received up to 70 mg/m\^2 MM-398 FBE (C1D1) administered as an IV infusion over 90 minutes, repeated every 2 weeks until disease progression, unacceptable toxicity or withdrawal of consent.	Expansion Phase: Cohort 3 Subjects with BC with active brain metastasis. FMX phase: Subjects received an IV infusion of 5 mg/kg FMX (up to 510 mg) administered over a minimum of 15 minutes on Day 1. Subjects underwent FMX-MRI scans and a pre-MM-398 treatment biopsy on Days 1 to 2. MM-398 Treatment phase: Within 7 days of the FMX infusion, subjects received up to 70 mg/m\^2 MM-398 FBE (C1D1) administered as an IV infusion over 90 minutes, repeated every 2 weeks until disease progression, unacceptable toxicity or withdrawal of consent.	Expansion Phase: Cohort 3 Subjects with BC with active brain metastasis. FMX phase: Subjects received an IV infusion of 5 mg/kg FMX (up to 510 mg) administered over a minimum of 15 minutes on Day 1. Subjects underwent FMX-MRI scans and a pre-MM-398 treatment biopsy on Days 1 to 2. MM-398 Treatment phase: Within 7 days of the FMX infusion, subjects received up to 70 mg/m\^2 MM-398 FBE (C1D1) administered as an IV infusion over 90 minutes, repeated every 2 weeks until disease progression, unacceptable toxicity or withdrawal of consent.
Pilot Phase: Area Under the Plasma Concentration Time Curve From Time Zero to Last Quantifiable Concentration (AUC[0-tlast]) for Irinotecan	1721 mcg*hours/mL (mcg*h/mL) Interval 293.0 to 3758.0	—	—	—

SECONDARY outcome

Timeframe: Pilot phase: C1D1 pre-MM-398 infusion, end of infusion, post-infusion (2, 72, 168 hours); C1D15 pre-infusion; 30 days follow-up visit.

Population: The PK set included subjects who received at least 1 dose of MM-398, blood samples were collected at the predefined points (with no major protocol deviations affecting PK variables \& sufficient number of plasma concentrations to estimate main PK parameters \[Cmax, AUC\]); analysis was within the sample stability period to estimate main PK parameters.

In Cycle 1 only of the Pilot phase, samples were collected to determine the levels of SN-38 (metabolite) in plasma following a dose of 70 mg/m^2 MM-398 FBE (80 mg/m^2 MM-398 SBE). The PK analysis was based on non-compartmental analysis. Any plasma concentrations below the LLOQ were assigned as missing/zero in the data set according to predetermined rules. The LLOQ for SN-38 for the Pilot phase was 0.441 ng/mL. The mean AUC(0-tlast) is presented for the Pilot phase.

Outcome measures

Measure	Pilot Phase: FMX Then MM-398 n=13 Participants FMX phase: Subjects received a single bolus IV injection of 5 mg/kg FMX (up to 510 mg) on Day 1. Subjects underwent FMX-MRI scans and pre-MM-398 treatment biopsies on Days 1 to 4. MM-398 Treatment phase: Within 7 days of the FMX infusion, subjects received up to 70 mg/m\^2 MM-398 FBE (C1D1) administered as an IV infusion over 90 minutes, repeated every 2 weeks until disease progression, unacceptable toxicity or withdrawal of consent.	Expansion Phase: Cohort 2 Subjects with TNBC. FMX phase: Subjects received an IV infusion of 5 mg/kg FMX (up to 510 mg) administered over a minimum of 15 minutes on Day 1. Subjects underwent FMX-MRI scans and a pre-MM-398 treatment biopsy on Days 1 to 2. MM-398 Treatment phase: Within 7 days of the FMX infusion, subjects received up to 70 mg/m\^2 MM-398 FBE (C1D1) administered as an IV infusion over 90 minutes, repeated every 2 weeks until disease progression, unacceptable toxicity or withdrawal of consent.	Expansion Phase: Cohort 3 Subjects with BC with active brain metastasis. FMX phase: Subjects received an IV infusion of 5 mg/kg FMX (up to 510 mg) administered over a minimum of 15 minutes on Day 1. Subjects underwent FMX-MRI scans and a pre-MM-398 treatment biopsy on Days 1 to 2. MM-398 Treatment phase: Within 7 days of the FMX infusion, subjects received up to 70 mg/m\^2 MM-398 FBE (C1D1) administered as an IV infusion over 90 minutes, repeated every 2 weeks until disease progression, unacceptable toxicity or withdrawal of consent.	Expansion Phase: Cohort 3 Subjects with BC with active brain metastasis. FMX phase: Subjects received an IV infusion of 5 mg/kg FMX (up to 510 mg) administered over a minimum of 15 minutes on Day 1. Subjects underwent FMX-MRI scans and a pre-MM-398 treatment biopsy on Days 1 to 2. MM-398 Treatment phase: Within 7 days of the FMX infusion, subjects received up to 70 mg/m\^2 MM-398 FBE (C1D1) administered as an IV infusion over 90 minutes, repeated every 2 weeks until disease progression, unacceptable toxicity or withdrawal of consent.
Pilot Phase: SN-38 AUC(0-tlast)	212 ng*h/mL Interval 89.1 to 380.0	—	—	—

SECONDARY outcome

Timeframe: Expansion phase: Cycles 1-3 pre-MM-398 infusion, end of infusion, post-infusion (2, 48,168 hours); D15 pre-infusion; 30 days follow-up visit.

Population: The PK set included subjects who received at least 1 dose of MM-398, blood samples were collected at the predefined points (with no major protocol deviations affecting PK variables \& sufficient number of plasma concentrations to estimate main PK parameters \[Cmax, AUC\]); analysis was within the sample stability period to estimate main PK parameters.

For the Expansion phase, samples were collected to determine the levels of total irinotecan (liposomal and free drug) in plasma and data is presented for Cycles 1 to 3 by dose received for each cycle (depending on dose titration): 35 to 70 mg/m^2 MM-398 FBE (40 to 80 mg/m^2 MM-398 SBE). The PK analysis was based on non-compartmental analysis. Any plasma concentrations below the LLOQ were assigned as missing/zero in the data set according to predetermined rules. The LLOQ for irinotecan was 0.140 mcg/mL. The mean AUC(0-tlast) is presented for the Expansion phase. PK results for subjects in all cohorts of the Expansion Phase were combined for those on the same cycle and at the same dose. The total number of subjects evaluated in the PK set for the Expansion Phase was 21, with different numbers evaluated for each cycle/dose.

Outcome measures

Measure	Pilot Phase: FMX Then MM-398 n=21 Participants FMX phase: Subjects received a single bolus IV injection of 5 mg/kg FMX (up to 510 mg) on Day 1. Subjects underwent FMX-MRI scans and pre-MM-398 treatment biopsies on Days 1 to 4. MM-398 Treatment phase: Within 7 days of the FMX infusion, subjects received up to 70 mg/m\^2 MM-398 FBE (C1D1) administered as an IV infusion over 90 minutes, repeated every 2 weeks until disease progression, unacceptable toxicity or withdrawal of consent.	Expansion Phase: Cohort 2 Subjects with TNBC. FMX phase: Subjects received an IV infusion of 5 mg/kg FMX (up to 510 mg) administered over a minimum of 15 minutes on Day 1. Subjects underwent FMX-MRI scans and a pre-MM-398 treatment biopsy on Days 1 to 2. MM-398 Treatment phase: Within 7 days of the FMX infusion, subjects received up to 70 mg/m\^2 MM-398 FBE (C1D1) administered as an IV infusion over 90 minutes, repeated every 2 weeks until disease progression, unacceptable toxicity or withdrawal of consent.	Expansion Phase: Cohort 3 Subjects with BC with active brain metastasis. FMX phase: Subjects received an IV infusion of 5 mg/kg FMX (up to 510 mg) administered over a minimum of 15 minutes on Day 1. Subjects underwent FMX-MRI scans and a pre-MM-398 treatment biopsy on Days 1 to 2. MM-398 Treatment phase: Within 7 days of the FMX infusion, subjects received up to 70 mg/m\^2 MM-398 FBE (C1D1) administered as an IV infusion over 90 minutes, repeated every 2 weeks until disease progression, unacceptable toxicity or withdrawal of consent.	Expansion Phase: Cohort 3 Subjects with BC with active brain metastasis. FMX phase: Subjects received an IV infusion of 5 mg/kg FMX (up to 510 mg) administered over a minimum of 15 minutes on Day 1. Subjects underwent FMX-MRI scans and a pre-MM-398 treatment biopsy on Days 1 to 2. MM-398 Treatment phase: Within 7 days of the FMX infusion, subjects received up to 70 mg/m\^2 MM-398 FBE (C1D1) administered as an IV infusion over 90 minutes, repeated every 2 weeks until disease progression, unacceptable toxicity or withdrawal of consent.
Expansion Phase: Irinotecan AUC(0-tlast) Cycle 1 40 mg/m^2 SBE	NA mcg*h/mL Interval 976.0 to 976.0 Descriptive statistics could not be determined for this sample size and therefore the mean value was not calculated.	—	—	—
Expansion Phase: Irinotecan AUC(0-tlast) Cycle 1 60 mg/m^2 SBE	1430 mcg*h/mL Interval 230.0 to 3301.0	—	—	—
Expansion Phase: Irinotecan AUC(0-tlast) Cycle 1 80 mg/m^2 SBE	1530 mcg*h/mL Interval 541.0 to 2273.0	—	—	—
Expansion Phase: Irinotecan AUC(0-tlast) Cycle 2 40 mg/m^2 SBE	NA mcg*h/mL Interval 1185.0 to 1185.0 Descriptive statistics could not be determined for this sample size and therefore the mean value was not calculated.	—	—	—
Expansion Phase: Irinotecan AUC(0-tlast) Cycle 2 60 mg/m^2 SBE	1589 mcg*h/mL Interval 204.0 to 2963.0	—	—	—
Expansion Phase: Irinotecan AUC(0-tlast) Cycle 2 80 mg/m^2 SBE	1788 mcg*h/mL Interval 902.0 to 2266.0	—	—	—
Expansion Phase: Irinotecan AUC(0-tlast) Cycle 3 40 mg/m^2 SBE	NA mcg*h/mL Interval 426.0 to 969.0 Descriptive statistics could not be determined for this sample size and therefore the mean value was not calculated.	—	—	—
Expansion Phase: Irinotecan AUC(0-tlast) Cycle 3 60 mg/m^2 SBE	1700 mcg*h/mL Interval 325.0 to 3001.0	—	—	—
Expansion Phase: Irinotecan AUC(0-tlast) Cycle 3 80 mg/m^2 SBE	NA mcg*h/mL Interval 1345.0 to 2288.0 Descriptive statistics could not be determined for this sample size and therefore the mean value was not calculated.	—	—	—

SECONDARY outcome

Timeframe: Expansion phase: Cycles 1-3 pre-MM-398 infusion, end of infusion, post-infusion (2, 48,168 hours); D15 pre-infusion; 30 days follow-up visit.

Population: The PK set included subjects who received at least 1 dose of MM-398, blood samples were collected at the predefined points (with no major protocol deviations affecting PK variables \& sufficient number of plasma concentrations to estimate main PK parameters \[Cmax, AUC\]); analysis was within the sample stability period to estimate main PK parameters.

For the Expansion phase, samples were collected to determine the levels of SN-38 (metabolite) in plasma and data is presented for Cycles 1 to 3 by dose received for each cycle (depending on dose titration): 35 to 70 mg/m^2 MM-398 FBE (40 to 80 mg/m^2 MM-398 SBE). The PK analysis was based on non-compartmental analysis. Any plasma concentrations below the LLOQ were assigned as missing/zero in the data set according to predetermined rules. The LLOQ for SN-38 for the Expansion phase was 0.600 ng/mL. The mean AUC(0-tlast) is presented for dose levels in the Expansion phase for which data was collected. PK results for subjects in all cohorts of the Expansion Phase were combined for those on the same cycle and at the same dose. The total number of subjects evaluated in the PK set for the Expansion Phase was 21, with different numbers evaluated for each cycle/dose.

Outcome measures

Measure	Pilot Phase: FMX Then MM-398 n=21 Participants FMX phase: Subjects received a single bolus IV injection of 5 mg/kg FMX (up to 510 mg) on Day 1. Subjects underwent FMX-MRI scans and pre-MM-398 treatment biopsies on Days 1 to 4. MM-398 Treatment phase: Within 7 days of the FMX infusion, subjects received up to 70 mg/m\^2 MM-398 FBE (C1D1) administered as an IV infusion over 90 minutes, repeated every 2 weeks until disease progression, unacceptable toxicity or withdrawal of consent.	Expansion Phase: Cohort 2 Subjects with TNBC. FMX phase: Subjects received an IV infusion of 5 mg/kg FMX (up to 510 mg) administered over a minimum of 15 minutes on Day 1. Subjects underwent FMX-MRI scans and a pre-MM-398 treatment biopsy on Days 1 to 2. MM-398 Treatment phase: Within 7 days of the FMX infusion, subjects received up to 70 mg/m\^2 MM-398 FBE (C1D1) administered as an IV infusion over 90 minutes, repeated every 2 weeks until disease progression, unacceptable toxicity or withdrawal of consent.	Expansion Phase: Cohort 3 Subjects with BC with active brain metastasis. FMX phase: Subjects received an IV infusion of 5 mg/kg FMX (up to 510 mg) administered over a minimum of 15 minutes on Day 1. Subjects underwent FMX-MRI scans and a pre-MM-398 treatment biopsy on Days 1 to 2. MM-398 Treatment phase: Within 7 days of the FMX infusion, subjects received up to 70 mg/m\^2 MM-398 FBE (C1D1) administered as an IV infusion over 90 minutes, repeated every 2 weeks until disease progression, unacceptable toxicity or withdrawal of consent.	Expansion Phase: Cohort 3 Subjects with BC with active brain metastasis. FMX phase: Subjects received an IV infusion of 5 mg/kg FMX (up to 510 mg) administered over a minimum of 15 minutes on Day 1. Subjects underwent FMX-MRI scans and a pre-MM-398 treatment biopsy on Days 1 to 2. MM-398 Treatment phase: Within 7 days of the FMX infusion, subjects received up to 70 mg/m\^2 MM-398 FBE (C1D1) administered as an IV infusion over 90 minutes, repeated every 2 weeks until disease progression, unacceptable toxicity or withdrawal of consent.
Expansion Phase: SN-38 AUC(0-tlast) Cycle 1 60 mg/m^2 SBE	237 ng*h/mL Interval 40.5 to 599.0	—	—	—
Expansion Phase: SN-38 AUC(0-tlast) Cycle 2 60 mg/m^2 SBE	NA ng*h/mL Interval 237.0 to 353.0 Descriptive statistics could not be determined for this sample size and therefore the mean value was not calculated.	—	—	—
Expansion Phase: SN-38 AUC(0-tlast) Cycle 2 80 mg/m^2 SBE	NA ng*h/mL Interval 354.0 to 354.0 Descriptive statistics could not be determined for this sample size and therefore the mean value was not calculated.	—	—	—
Expansion Phase: SN-38 AUC(0-tlast) Cycle 3 60 mg/m^2 SBE	214 ng*h/mL Interval 146.0 to 295.0	—	—	—
Expansion Phase: SN-38 AUC(0-tlast) Cycle 3 80 mg/m^2 SBE	NA ng*h/mL Interval 119.0 to 119.0 Descriptive statistics could not be determined for this sample size and therefore the mean value was not calculated.	—	—	—

Adverse Events

Pilot Phase: FMX Then MM-398

Serious events: 4 serious events

Other events: 13 other events

Deaths: 2 deaths

Expansion Phase: FMX Then MM-398

Serious events: 17 serious events

Other events: 29 other events

Deaths: 1 deaths

Serious adverse events

Measure	Pilot Phase: FMX Then MM-398 n=13 participants at risk FMX phase: Subjects received a single bolus IV injection of 5 mg/kg FMX (up to 510 mg) on Day 1. Subjects underwent FMX-MRI scans and pre-MM-398 treatment biopsies on Days 1 to 4. MM-398 Treatment phase: Within 7 days of the FMX infusion, subjects received up to 70 mg/m\^2 MM-398 FBE (C1D1) administered as an IV infusion over 90 minutes, repeated every 2 weeks until disease progression, unacceptable toxicity or withdrawal of consent.	Expansion Phase: FMX Then MM-398 n=29 participants at risk FMX phase: Subjects received an IV infusion of 5 mg/kg FMX (up to 510 mg) administered over a minimum of 15 minutes on Day 1. Subjects underwent FMX-MRI scans and a pre-MM-398 treatment biopsy on Days 1 to 2. MM-398 Treatment phase: Within 7 days of the FMX infusion, subjects received up to 70 mg/m\^2 MM-398 FBE (C1D1) administered as an IV infusion over 90 minutes, repeated every 2 weeks until disease progression, unacceptable toxicity or withdrawal of consent. Cohort 1: ER and/or PR-positive BC and HER-2 negative BC. Cohort 2: TNBC. Cohort 3: BC with active brain metastasis.
Gastrointestinal disorders Diarrhoea	7.7% 1/13 • Number of events 1 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.	17.2% 5/29 • Number of events 5 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.
Gastrointestinal disorders Nausea	7.7% 1/13 • Number of events 1 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.	10.3% 3/29 • Number of events 3 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.
Gastrointestinal disorders Abdominal pain	15.4% 2/13 • Number of events 2 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.	3.4% 1/29 • Number of events 1 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.
Gastrointestinal disorders Vomiting	7.7% 1/13 • Number of events 1 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.	3.4% 1/29 • Number of events 1 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.
Gastrointestinal disorders Colitis	7.7% 1/13 • Number of events 1 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.	0.00% 0/29 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.
Gastrointestinal disorders Duodenal perforation	0.00% 0/13 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.	3.4% 1/29 • Number of events 1 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.
Gastrointestinal disorders Enteritis	0.00% 0/13 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.	3.4% 1/29 • Number of events 1 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.
Infections and infestations Pneumonia	0.00% 0/13 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.	6.9% 2/29 • Number of events 2 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.
Infections and infestations Urinary tract infection	0.00% 0/13 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.	3.4% 1/29 • Number of events 4 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.
Infections and infestations Coccidioidomycosis	0.00% 0/13 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.	3.4% 1/29 • Number of events 1 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.
Infections and infestations Influenza	0.00% 0/13 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.	3.4% 1/29 • Number of events 1 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.
Infections and infestations Sepsis	0.00% 0/13 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.	3.4% 1/29 • Number of events 1 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.
Infections and infestations Urinary tract infection staphylococcal	0.00% 0/13 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.	3.4% 1/29 • Number of events 1 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.
General disorders Asthenia	0.00% 0/13 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.	10.3% 3/29 • Number of events 3 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.
General disorders Fatigue	0.00% 0/13 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.	3.4% 1/29 • Number of events 1 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.
General disorders Pyrexia	0.00% 0/13 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.	3.4% 1/29 • Number of events 1 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.
Nervous system disorders Aphasia	0.00% 0/13 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.	3.4% 1/29 • Number of events 1 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.
Nervous system disorders Dizziness	0.00% 0/13 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.	3.4% 1/29 • Number of events 1 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.
Nervous system disorders Dysaesthesia	0.00% 0/13 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.	3.4% 1/29 • Number of events 1 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.
Nervous system disorders Headache	0.00% 0/13 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.	3.4% 1/29 • Number of events 1 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.
Nervous system disorders Hydrocephalus	0.00% 0/13 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.	3.4% 1/29 • Number of events 1 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.
Nervous system disorders Lethargy	0.00% 0/13 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.	3.4% 1/29 • Number of events 1 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/13 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.	3.4% 1/29 • Number of events 1 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/13 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.	3.4% 1/29 • Number of events 1 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.
Respiratory, thoracic and mediastinal disorders Pulmonary haemorrhage	0.00% 0/13 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.	3.4% 1/29 • Number of events 1 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.
Investigations Alanine aminotransferase increased	0.00% 0/13 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.	3.4% 1/29 • Number of events 1 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.
Investigations Aspartate aminotransferase increased	0.00% 0/13 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.	3.4% 1/29 • Number of events 1 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.
Investigations Troponin increased	0.00% 0/13 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.	3.4% 1/29 • Number of events 1 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.
Psychiatric disorders Confusional state	0.00% 0/13 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.	3.4% 1/29 • Number of events 1 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.
Psychiatric disorders Mental status changes	0.00% 0/13 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.	3.4% 1/29 • Number of events 1 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.
Cardiac disorders Pericardial effusion	0.00% 0/13 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.	3.4% 1/29 • Number of events 1 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.
Hepatobiliary disorders Cholecystitis acute	0.00% 0/13 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.	3.4% 1/29 • Number of events 1 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.
Injury, poisoning and procedural complications Femur fracture	0.00% 0/13 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.	3.4% 1/29 • Number of events 1 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/13 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.	3.4% 1/29 • Number of events 1 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/13 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.	3.4% 1/29 • Number of events 1 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to meninges	7.7% 1/13 • Number of events 1 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.	0.00% 0/29 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.

Other adverse events

Measure	Pilot Phase: FMX Then MM-398 n=13 participants at risk FMX phase: Subjects received a single bolus IV injection of 5 mg/kg FMX (up to 510 mg) on Day 1. Subjects underwent FMX-MRI scans and pre-MM-398 treatment biopsies on Days 1 to 4. MM-398 Treatment phase: Within 7 days of the FMX infusion, subjects received up to 70 mg/m\^2 MM-398 FBE (C1D1) administered as an IV infusion over 90 minutes, repeated every 2 weeks until disease progression, unacceptable toxicity or withdrawal of consent.	Expansion Phase: FMX Then MM-398 n=29 participants at risk FMX phase: Subjects received an IV infusion of 5 mg/kg FMX (up to 510 mg) administered over a minimum of 15 minutes on Day 1. Subjects underwent FMX-MRI scans and a pre-MM-398 treatment biopsy on Days 1 to 2. MM-398 Treatment phase: Within 7 days of the FMX infusion, subjects received up to 70 mg/m\^2 MM-398 FBE (C1D1) administered as an IV infusion over 90 minutes, repeated every 2 weeks until disease progression, unacceptable toxicity or withdrawal of consent. Cohort 1: ER and/or PR-positive BC and HER-2 negative BC. Cohort 2: TNBC. Cohort 3: BC with active brain metastasis.
Gastrointestinal disorders Diarrhoea	69.2% 9/13 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.	86.2% 25/29 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.
Gastrointestinal disorders Nausea	69.2% 9/13 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.	51.7% 15/29 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.
Gastrointestinal disorders Vomiting	53.8% 7/13 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.	37.9% 11/29 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.
Gastrointestinal disorders Constipation	38.5% 5/13 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.	17.2% 5/29 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.
Gastrointestinal disorders Abdominal pain	15.4% 2/13 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.	20.7% 6/29 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.
Gastrointestinal disorders Dyspepsia	15.4% 2/13 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.	6.9% 2/29 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.
Gastrointestinal disorders Flatulence	7.7% 1/13 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.	10.3% 3/29 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.
Gastrointestinal disorders Stomatitis	7.7% 1/13 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.	6.9% 2/29 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.
Gastrointestinal disorders Abdominal distension	7.7% 1/13 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.	6.9% 2/29 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.
Gastrointestinal disorders Oral pain	0.00% 0/13 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.	10.3% 3/29 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.
Gastrointestinal disorders Ascites	7.7% 1/13 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.	3.4% 1/29 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/13 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.	6.9% 2/29 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.
Gastrointestinal disorders Colitis	7.7% 1/13 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.	0.00% 0/29 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.
Gastrointestinal disorders Gastrooesophageal reflux disease	7.7% 1/13 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.	3.4% 1/29 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.
Gastrointestinal disorders Faecaloma	7.7% 1/13 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.	0.00% 0/29 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.
Gastrointestinal disorders Oesophageal stenosis	7.7% 1/13 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.	0.00% 0/29 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.
Metabolism and nutrition disorders Hypokalaemia	61.5% 8/13 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.	37.9% 11/29 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.
Metabolism and nutrition disorders Decreased appetite	23.1% 3/13 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.	31.0% 9/29 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.
Metabolism and nutrition disorders Hypomagnesaemia	23.1% 3/13 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.	13.8% 4/29 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.
Metabolism and nutrition disorders Hypocalcaemia	0.00% 0/13 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.	20.7% 6/29 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.
Metabolism and nutrition disorders Dehydration	15.4% 2/13 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.	13.8% 4/29 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.
Metabolism and nutrition disorders Hypophosphataemia	15.4% 2/13 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.	10.3% 3/29 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.
Metabolism and nutrition disorders Hypoalbuminaemia	0.00% 0/13 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.	13.8% 4/29 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.
Metabolism and nutrition disorders Hyperglycaemia	7.7% 1/13 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.	6.9% 2/29 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.
Metabolism and nutrition disorders Hyponatraemia	15.4% 2/13 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.	3.4% 1/29 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.
Metabolism and nutrition disorders Hypercalcaemia	7.7% 1/13 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.	3.4% 1/29 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.
Metabolism and nutrition disorders Malnutrition	0.00% 0/13 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.	6.9% 2/29 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.
Metabolism and nutrition disorders Iron deficiency	7.7% 1/13 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.	0.00% 0/29 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.
General disorders Fatigue	23.1% 3/13 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.	58.6% 17/29 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.
General disorders Asthenia	0.00% 0/13 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.	10.3% 3/29 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.
General disorders Oedema peripheral	7.7% 1/13 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.	10.3% 3/29 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.
General disorders Chills	7.7% 1/13 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.	3.4% 1/29 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.
General disorders Mucosal inflammation	7.7% 1/13 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.	0.00% 0/29 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.
General disorders Non-cardiac chest pain	7.7% 1/13 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.	0.00% 0/29 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.
Musculoskeletal and connective tissue disorders Back pain	7.7% 1/13 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.	24.1% 7/29 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.
Musculoskeletal and connective tissue disorders Muscle spasms	15.4% 2/13 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.	13.8% 4/29 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/13 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.	13.8% 4/29 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.
Musculoskeletal and connective tissue disorders Neck pain	7.7% 1/13 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.	10.3% 3/29 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.
Musculoskeletal and connective tissue disorders Bone pain	7.7% 1/13 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.	6.9% 2/29 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.
Musculoskeletal and connective tissue disorders Flank pain	0.00% 0/13 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.	6.9% 2/29 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/13 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.	6.9% 2/29 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/13 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.	6.9% 2/29 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/13 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.	6.9% 2/29 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.
Nervous system disorders Headache	23.1% 3/13 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.	20.7% 6/29 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.
Nervous system disorders Dizziness	15.4% 2/13 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.	6.9% 2/29 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.
Nervous system disorders Dysgeusia	15.4% 2/13 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.	3.4% 1/29 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.
Nervous system disorders Neuropathy peripheral	0.00% 0/13 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.	10.3% 3/29 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.
Infections and infestations Urinary tract infection	23.1% 3/13 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.	13.8% 4/29 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.
Infections and infestations Pneumonia	15.4% 2/13 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.	0.00% 0/29 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.
Infections and infestations Bronchitis	7.7% 1/13 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.	6.9% 2/29 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.
Infections and infestations Upper respiratory tract infection	0.00% 0/13 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.	6.9% 2/29 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.
Infections and infestations Enterocolitis infection	7.7% 1/13 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.	0.00% 0/29 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.
Infections and infestations Lymphangitis	7.7% 1/13 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.	0.00% 0/29 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.
Infections and infestations Sinusitis	7.7% 1/13 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.	0.00% 0/29 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.
Infections and infestations Skin candida	7.7% 1/13 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.	0.00% 0/29 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.
Infections and infestations Urinary tract infection enterococcal	7.7% 1/13 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.	0.00% 0/29 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.
Respiratory, thoracic and mediastinal disorders Cough	7.7% 1/13 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.	20.7% 6/29 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/13 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.	17.2% 5/29 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	7.7% 1/13 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.	3.4% 1/29 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/13 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.	6.9% 2/29 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.00% 0/13 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.	6.9% 2/29 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.
Investigations Alanine aminotransferase increased	0.00% 0/13 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.	20.7% 6/29 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.
Investigations Neutrophil count decreased	0.00% 0/13 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.	17.2% 5/29 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.
Investigations Aspartate aminotransferase increased	0.00% 0/13 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.	13.8% 4/29 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.
Investigations Weight decreased	0.00% 0/13 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.	13.8% 4/29 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.
Investigations Blood alkaline phosphatase increased	0.00% 0/13 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.	10.3% 3/29 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.
Investigations White blood cell count decreased	0.00% 0/13 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.	10.3% 3/29 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.
Investigations Lymphocyte count decreased	0.00% 0/13 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.	10.3% 3/29 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.
Investigations Blood phosphorous decreased	0.00% 0/13 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.	6.9% 2/29 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.
Investigations Transaminases increased	7.7% 1/13 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.	3.4% 1/29 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.
Blood and lymphatic system disorders Anaemia	38.5% 5/13 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.	24.1% 7/29 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.
Blood and lymphatic system disorders Neutropenia	30.8% 4/13 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.	6.9% 2/29 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.
Blood and lymphatic system disorders Thrombocytopenia	23.1% 3/13 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.	0.00% 0/29 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.
Skin and subcutaneous tissue disorders Alopecia	15.4% 2/13 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.	20.7% 6/29 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysaesthesia syndrome	0.00% 0/13 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.	6.9% 2/29 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.
Skin and subcutaneous tissue disorders Rash	0.00% 0/13 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.	6.9% 2/29 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.
Skin and subcutaneous tissue disorders Ecchymosis	7.7% 1/13 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.	0.00% 0/29 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.
Skin and subcutaneous tissue disorders Erythema	7.7% 1/13 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.	0.00% 0/29 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.
Psychiatric disorders Anxiety	7.7% 1/13 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.	13.8% 4/29 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.
Psychiatric disorders Insomnia	0.00% 0/13 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.	10.3% 3/29 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.
Psychiatric disorders Depression	0.00% 0/13 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.	6.9% 2/29 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.
Injury, poisoning and procedural complications Contusion	0.00% 0/13 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.	6.9% 2/29 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.
Injury, poisoning and procedural complications Fall	0.00% 0/13 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.	6.9% 2/29 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.
Eye disorders Blepharospasm	0.00% 0/13 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.	6.9% 2/29 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.
Eye disorders Vision blurred	0.00% 0/13 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.	6.9% 2/29 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.
Vascular disorders Hypotension	0.00% 0/13 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.	10.3% 3/29 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.
Vascular disorders Hypertension	7.7% 1/13 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.	0.00% 0/29 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.
Renal and urinary disorders Dysuria	7.7% 1/13 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.	3.4% 1/29 • TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing. TEAEs are presented for the MM-398 safety population which included all subjects who received at least 1 dose of MM-398. All analyses using this population were based on the treatment actually received. All cause mortality is presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398, and the subjects affected received FMX only. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.

Additional Information

Medical Director

Ipsen Bioscience, Inc

Phone: See email

Email: clinical.trials@ipsen.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place