Trial Outcomes & Findings for A Study of DKN-01 in Multiple Myeloma or Advanced Solid Tumors (NCT NCT01457417)

Results Overview

Total Adverse Events (AE), total treatment emergent adverse events (TEAE), total Serious Adverse Events (SAE), and total dose-limiting toxicity (DLT) for both Parts A and B.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

32 participants

Primary outcome timeframe

Baseline to study completion (approximately 3 months)

Results posted on

2016-09-28

Participant Flow

Eight sites in the United States participated in the study and 7 of them enrolled patients. The Date of First Enrollment was 16 Jan 2012, and the Date of Last Completed was 06 Dec 2013.

Part A enrolled patients with histologically or cytologically confirmed multiple myeloma or advanced solid tumors. A dose escalation procedure was followed. Part B enrolled patients with non-small cell lung cancer. Following screening (up to 28 days prior to first treatment) if entry criterion was met, patients were eligible for enrollment.

Participant milestones

Participant milestones
Measure	75 Milligram (mg) DKN-01 Part A (QW) DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) were met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method was guided by the incidence of DLTs during the first cycle.	150 mg DKN-01 Part A (QW) DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) were met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method will be guided by the incidence of DLTs during the first cycle.	300 mg DKN-01 Part A (QW) DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) was met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method was guided by the incidence of DLTs during the first cycle.	600 mg DKN-01 Part A (Q2W) DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) were met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method was guided by the incidence of DLTs during the first cycle.	300 mg DKN-01 Part B (Q2W) Dose Confirmation: Once the MTD had been established or the highest planned dose level completed, 300 mg of DKN-01 was administered as IV on days 1 and 15 of every 28 day cycle.
Overall Study STARTED	3	3	4	3	19
Overall Study COMPLETED	3	3	4	3	19
Overall Study NOT COMPLETED	0	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study of DKN-01 in Multiple Myeloma or Advanced Solid Tumors

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	75 Milligram (mg) DKN-01 Part A n=3 Participants DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) were met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method was guided by the incidence of DLTs during the first cycle.	150 mg DKN-01 Part A n=3 Participants DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) were met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method will be guided by the incidence of DLTs during the first cycle.	300 mg DKN-01 Part A n=4 Participants DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) was met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method was guided by the incidence of DLTs during the first cycle.	600 mg DKN-01 Part A n=3 Participants DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) were met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method was guided by the incidence of DLTs during the first cycle.	300 mg DKN-01 Part B n=19 Participants Dose Confirmation: Once the MTD had been established or the highest planned dose level completed, 300 mg of DKN-01 was administered as IV on days 1 and 15 of every 28 day cycle.	Total n=32 Participants Total of all reporting groups
Age, Continuous	57.7 years STANDARD_DEVIATION 7.77 • n=5 Participants	66.3 years STANDARD_DEVIATION 8.62 • n=7 Participants	65.0 years STANDARD_DEVIATION 19.20 • n=5 Participants	68.3 years STANDARD_DEVIATION 8.96 • n=4 Participants	65.4 years STANDARD_DEVIATION 9.25 • n=21 Participants	65.0 years STANDARD_DEVIATION 10.29 • n=10 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	1 Participants n=4 Participants	10 Participants n=21 Participants	17 Participants n=10 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	2 Participants n=4 Participants	9 Participants n=21 Participants	15 Participants n=10 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants	1 Participants n=4 Participants	9 Participants n=21 Participants	18 Participants n=10 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants	10 Participants n=21 Participants	14 Participants n=10 Participants
Region of Enrollment United States	3 participants n=5 Participants	3 participants n=7 Participants	4 participants n=5 Participants	3 participants n=4 Participants	19 participants n=21 Participants	32 participants n=10 Participants

PRIMARY outcome

Timeframe: Baseline to study completion (approximately 3 months)

Population: Safety analyses were based on the full analysis set (FAS), which was defined as all patients who received at least one dose of study treatment during Part A or Part B of the study.

Total Adverse Events (AE), total treatment emergent adverse events (TEAE), total Serious Adverse Events (SAE), and total dose-limiting toxicity (DLT) for both Parts A and B.

Outcome measures

Outcome measures
Measure	75 Milligram (mg) DKN-01 Part A (QW) n=3 Participants DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) were met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method was guided by the incidence of DLTs during the first cycle.	150 mg DKN-01 Part A (QW) n=3 Participants DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) were met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method will be guided by the incidence of DLTs during the first cycle.	300 mg DKN-01 Part A (QW) n=4 Participants DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) was met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method was guided by the incidence of DLTs during the first cycle.	600 mg DKN-01 Part A (Q2W) n=3 Participants DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) were met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method was guided by the incidence of DLTs during the first cycle.	300 mg DKN-01 Part B (Q2W) n=19 Participants Dose Confirmation: Once the MTD had been established or the highest planned dose level completed, 300 mg of DKN-01 was administered as IV on days 1 and 15 of every 28 day cycle.	Total n=32 Participants Total across all treatment groups
Summary of Total Adverse Events (AE) Total DLTs	0 Events	0 Events	0 Events	0 Events	0 Events	0 Events
Summary of Total Adverse Events (AE) Total AEs	39 Events	58 Events	35 Events	11 Events	87 Events	230 Events
Summary of Total Adverse Events (AE) Total TEAEs	39 Events	58 Events	35 Events	9 Events	87 Events	228 Events
Summary of Total Adverse Events (AE) Total SAEs	2 Events	7 Events	3 Events	0 Events	11 Events	23 Events

PRIMARY outcome

Timeframe: Baseline to study completion (approximately 3 months)

Population: Safety analyses were based on the full analysis set (FAS), which was defined as all patients who received at least one dose of study treatment during Part A or Part B of the study.

Number of patients who had Adverse Events (AE) including treatment related treatment emergent adverse events (TEAE), Common Toxicity Criteria for Adverse Effects (CTCAE), and Serious Adverse Events (SAE) for both Parts A and B. Severity was coded to NCI CTCAE version 4.02. For maximum severity and relationship, patients were counted only once in the most severe or most related category.

Outcome measures

Outcome measures
Measure	75 Milligram (mg) DKN-01 Part A (QW) n=3 Participants DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) were met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method was guided by the incidence of DLTs during the first cycle.	150 mg DKN-01 Part A (QW) n=3 Participants DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) were met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method will be guided by the incidence of DLTs during the first cycle.	300 mg DKN-01 Part A (QW) n=4 Participants DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) was met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method was guided by the incidence of DLTs during the first cycle.	600 mg DKN-01 Part A (Q2W) n=3 Participants DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) were met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method was guided by the incidence of DLTs during the first cycle.	300 mg DKN-01 Part B (Q2W) n=19 Participants Dose Confirmation: Once the MTD had been established or the highest planned dose level completed, 300 mg of DKN-01 was administered as IV on days 1 and 15 of every 28 day cycle.	Total n=32 Participants Total across all treatment groups
Summary of Patients With Adverse Events (AE) TEAE of Maximum CTCAE - Grade 2 Moderate	2 Patients	1 Patients	1 Patients	3 Patients	6 Patients	13 Patients
Summary of Patients With Adverse Events (AE) TEAE of Maximum CTCAE - Grade 3 Severe	0 Patients	2 Patients	3 Patients	0 Patients	9 Patients	14 Patients
Summary of Patients With Adverse Events (AE) TEAE of Maximum CTCAE - Grade 4 Life Threatening	1 Patients	0 Patients	0 Patients	0 Patients	0 Patients	1 Patients
Summary of Patients With Adverse Events (AE) TEAE Grade ≥ 3 assessed as study drug related	0 Patients	0 Patients	0 Patients	0 Patients	0 Patients	0 Patients
Summary of Patients With Adverse Events (AE) TEAE of Maximum Relationship - Not Related	2 Patients	1 Patients	1 Patients	2 Patients	8 Patients	14 Patients
Summary of Patients With Adverse Events (AE) At Least One TEAE Leading to Study Discontinuation	0 Patients	0 Patients	0 Patients	0 Patients	0 Patients	0 Patients
Summary of Patients With Adverse Events (AE) At Least One TEAE with Outcome of Death	0 Patients	0 Patients	0 Patients	0 Patients	1 Patients	1 Patients
Summary of Patients With Adverse Events (AE) Retracted SAE	1 Patients	2 Patients	0 Patients	0 Patients	2 Patients	5 Patients
Summary of Patients With Adverse Events (AE) At Least One AE	3 Patients	3 Patients	4 Patients	3 Patients	16 Patients	29 Patients
Summary of Patients With Adverse Events (AE) SAE related to study drug	0 Patients	0 Patients	0 Patients	0 Patients	0 Patients	0 Patients
Summary of Patients With Adverse Events (AE) TEAE of Maximum CTCAE - Grade 1 Mild	0 Patients	0 Patients	0 Patients	0 Patients	0 Patients	0 Patients
Summary of Patients With Adverse Events (AE) At Least One TEAE	3 Patients	3 Patients	4 Patients	3 Patients	16 Patients	29 Patients
Summary of Patients With Adverse Events (AE) At Least One SAE	1 Patients	2 Patients	1 Patients	0 Patients	7 Patients	11 Patients
Summary of Patients With Adverse Events (AE) TEAE of Maximum CTCAE - Grade 5 Death	0 Patients	0 Patients	0 Patients	0 Patients	1 Patients	1 Patients
Summary of Patients With Adverse Events (AE) TEAE of Maximum Relationship - Related	1 Patients	2 Patients	3 Patients	1 Patients	8 Patients	15 Patients
Summary of Patients With Adverse Events (AE) At Least One TEAE Leading to Drug Withdrawal	0 Patients	1 Patients	0 Patients	0 Patients	3 Patients	4 Patients

PRIMARY outcome

Timeframe: Time from the date of signed informed consent to the first date of objectively determined progressive disease or death from any cause

Population: Patients with advanced NSCLC receiving the study drug at 300 mg every 2 weeks in Part B

For Part B only. The distribution of PFS was estimated using the Kaplan-Meier (KM) method. PFS was defined as the time from the date of signed informed consent to the first date of objectively determined progressive disease (Progression is defined by Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) and International Multiple Myeloma Working Group (IMWG)) or death from any cause. For patients who were still alive at the time of analysis (ie, data cut-off date) and without evidence of tumor progression, PFS was censored at the date of the most recent objective progression-free observation.

Outcome measures

Outcome measures
Measure	75 Milligram (mg) DKN-01 Part A (QW) n=18 Participants DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) were met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method was guided by the incidence of DLTs during the first cycle.	150 mg DKN-01 Part A (QW) DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) were met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method will be guided by the incidence of DLTs during the first cycle.	300 mg DKN-01 Part A (QW) DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) was met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method was guided by the incidence of DLTs during the first cycle.	600 mg DKN-01 Part A (Q2W) DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) were met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method was guided by the incidence of DLTs during the first cycle.	300 mg DKN-01 Part B (Q2W) Dose Confirmation: Once the MTD had been established or the highest planned dose level completed, 300 mg of DKN-01 was administered as IV on days 1 and 15 of every 28 day cycle.	Total Total across all treatment groups
Progression Free Survival (PFS) in Patients With Relapsed or Refractory Non-small Cell Lung Cancer (NSCLC)	2.2 months Interval 1.5 to 2.9	—	—	—	—	—

SECONDARY outcome

Timeframe: Cycle 1 Day 1 (first dose, all groups)

Population: All patients who received at least one dose of study treatment during Part A or Part B of the study.

Area under the DKN-01 serum concentration-time profile curve during the dosing interval (AUC0-tau) after the first and fourth infusion for both Parts A and B. Cycle 1 Day 1 included once per week (QW) dosing groups and every two weeks (Q2W) dosing groups.

Outcome measures

Outcome measures
Measure	75 Milligram (mg) DKN-01 Part A (QW) n=3 Participants DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) were met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method was guided by the incidence of DLTs during the first cycle.	150 mg DKN-01 Part A (QW) n=3 Participants DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) were met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method will be guided by the incidence of DLTs during the first cycle.	300 mg DKN-01 Part A (QW) n=3 Participants DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) was met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method was guided by the incidence of DLTs during the first cycle.	600 mg DKN-01 Part A (Q2W) n=3 Participants DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) were met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method was guided by the incidence of DLTs during the first cycle.	300 mg DKN-01 Part B (Q2W) n=18 Participants Dose Confirmation: Once the MTD had been established or the highest planned dose level completed, 300 mg of DKN-01 was administered as IV on days 1 and 15 of every 28 day cycle.	Total Total across all treatment groups
Pharmacokinetics: Area Under the Concentration - Time Curve (AUC) of DKN-01	1942552.08830 hr*ng/mL Standard Deviation 780226.768012	4381685.27190 hr*ng/mL Standard Deviation 402701.016054	10860453.92050 hr*ng/mL Standard Deviation 2319628.494223	18103276.11133 hr*ng/mL Standard Deviation 1250736.327819	18398867.35928 hr*ng/mL Standard Deviation 5107540.116369	—

SECONDARY outcome

Timeframe: Cycle 1 Day 22 (Fourth Dose for QW)

Population: All patients who received at least one dose of study treatment during Part A study.

Area under the DKN-01 serum concentration-time profile curve during the dosing interval (AUC0-tau) after the first and fourth infusion for both Parts A and B. Cycle 1 day 22 included only QW dosing groups.

Outcome measures

Outcome measures
Measure	75 Milligram (mg) DKN-01 Part A (QW) n=3 Participants DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) were met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method was guided by the incidence of DLTs during the first cycle.	150 mg DKN-01 Part A (QW) n=3 Participants DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) were met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method will be guided by the incidence of DLTs during the first cycle.	300 mg DKN-01 Part A (QW) n=3 Participants DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) was met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method was guided by the incidence of DLTs during the first cycle.	600 mg DKN-01 Part A (Q2W) DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) were met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method was guided by the incidence of DLTs during the first cycle.	300 mg DKN-01 Part B (Q2W) Dose Confirmation: Once the MTD had been established or the highest planned dose level completed, 300 mg of DKN-01 was administered as IV on days 1 and 15 of every 28 day cycle.	Total Total across all treatment groups
Pharmacokinetics: Area Under the Concentration - Time Curve (AUC) of DKN-01	5663382.27007 hr*ng/mL Standard Deviation 3919446.471337	15815320.60770 hr*ng/mL Standard Deviation 5614032.150398	25639949.52467 hr*ng/mL Standard Deviation 4567585.003954	—	—	—

SECONDARY outcome

Timeframe: Cycle 1 Day 1 (first dose, all groups)

Population: All patients who received at least one dose of study treatment during Part A or Part B of the study.

Peak DKN-01 serum concentration (Cmax) after the first and fourth infusion on Cycle 1 Weeks 1 and 4, for both Parts A and B. Cycle 1 Day 1 included once per week (QW) dosing groups and every two weeks (Q2W) dosing groups.

Outcome measures

Outcome measures
Measure	75 Milligram (mg) DKN-01 Part A (QW) n=3 Participants DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) were met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method was guided by the incidence of DLTs during the first cycle.	150 mg DKN-01 Part A (QW) n=3 Participants DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) were met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method will be guided by the incidence of DLTs during the first cycle.	300 mg DKN-01 Part A (QW) n=3 Participants DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) was met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method was guided by the incidence of DLTs during the first cycle.	600 mg DKN-01 Part A (Q2W) n=3 Participants DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) were met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method was guided by the incidence of DLTs during the first cycle.	300 mg DKN-01 Part B (Q2W) n=18 Participants Dose Confirmation: Once the MTD had been established or the highest planned dose level completed, 300 mg of DKN-01 was administered as IV on days 1 and 15 of every 28 day cycle.	Total Total across all treatment groups
Pharmacokinetic: Maximum Plasma Concentration (Cmax) of DKN-01	22756.09897 ng/mL Standard Deviation 7665.992335	47838.87113 ng/mL Standard Deviation 4193.154016	130105.94600 ng/mL Standard Deviation 25705.162094	183063.33233 ng/mL Standard Deviation 34635.447386	119837.93546 ng/mL Standard Deviation 43565.776017	—

SECONDARY outcome

Timeframe: Cycle 1 Day 22 (Fourth dose for QW groups)

Population: All patients who received at least one dose of study treatment during Part A of the study.

Peak DKN-01 serum concentration (Cmax) after the fourth infusion on Cycle 1 Weeks 1 and 4, for both Parts A and B. Cycle 1 day 22 included only QW dosing groups.

Outcome measures

Outcome measures
Measure	75 Milligram (mg) DKN-01 Part A (QW) n=3 Participants DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) were met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method was guided by the incidence of DLTs during the first cycle.	150 mg DKN-01 Part A (QW) n=3 Participants DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) were met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method will be guided by the incidence of DLTs during the first cycle.	300 mg DKN-01 Part A (QW) n=3 Participants DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) was met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method was guided by the incidence of DLTs during the first cycle.	600 mg DKN-01 Part A (Q2W) DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) were met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method was guided by the incidence of DLTs during the first cycle.	300 mg DKN-01 Part B (Q2W) Dose Confirmation: Once the MTD had been established or the highest planned dose level completed, 300 mg of DKN-01 was administered as IV on days 1 and 15 of every 28 day cycle.	Total Total across all treatment groups
Pharmacokinetic: Maximum Plasma Concentration (Cmax) of DKN-01	43203.11520 ng/mL Standard Deviation 25085.681036	105148.29720 ng/mL Standard Deviation 29480.395189	224382.14533 ng/mL Standard Deviation 28438.209780	—	—	—

SECONDARY outcome

Timeframe: Time from the date of signed informed consent to the first date of objectively determined progressive disease or death from any cause

Population: All patients who received at least one dose of study treatment during Part A or Part B of the study.

For both Parts A and B. PFS was defined as the time from the date of signed informed consent to the first date of objectively determined progressive disease (Progression is defined by Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) and International Multiple Myeloma Working Group (IMWG)) or death from any cause. For patients who were still alive at the time of analysis (i.e, data cut-off date) and without evidence of tumor progression, PFS was censored at the date of the most recent objective progression-free observation.

Outcome measures

Outcome measures
Measure	75 Milligram (mg) DKN-01 Part A (QW) n=3 Participants DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) were met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method was guided by the incidence of DLTs during the first cycle.	150 mg DKN-01 Part A (QW) n=3 Participants DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) were met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method will be guided by the incidence of DLTs during the first cycle.	300 mg DKN-01 Part A (QW) n=4 Participants DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) was met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method was guided by the incidence of DLTs during the first cycle.	600 mg DKN-01 Part A (Q2W) n=3 Participants DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) were met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method was guided by the incidence of DLTs during the first cycle.	300 mg DKN-01 Part B (Q2W) n=19 Participants Dose Confirmation: Once the MTD had been established or the highest planned dose level completed, 300 mg of DKN-01 was administered as IV on days 1 and 15 of every 28 day cycle.	Total Total across all treatment groups
Progression Free Survival (PFS) in Patients Who Are Refractory or Intolerant to Standard/Approved Therapies	3.4 Months Interval 2.2 to 4.7	2.4 Months Interval 1.7 to 3.3	2.1 Months Interval 1.5 to 2.2	2.1 Months Interval 2.1 to 2.2	2.2 Months Interval 1.5 to 2.9	—

SECONDARY outcome

Timeframe: Time from the date of signed informed consent to the date of death from any cause

Population: For patients who are still alive as of the data cut-off date, OS time will be censored on the date of the patient's last contact (last contact for patients in post-discontinuation = last Date of Contact in Long Term Follow-up eCRF).

For Part B only. OS was defined as the time from the date of signed informed consent to the date of death from any cause. For patients who were still alive as of the data cut-off date, OS time was censored on the date of the patient's last contact (last contact for patients in post-discontinuation was the last date of contact in long-term follow-up eCRF).

Outcome measures

Outcome measures
Measure	75 Milligram (mg) DKN-01 Part A (QW) n=19 Participants DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) were met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method was guided by the incidence of DLTs during the first cycle.	150 mg DKN-01 Part A (QW) DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) were met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method will be guided by the incidence of DLTs during the first cycle.	300 mg DKN-01 Part A (QW) DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) was met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method was guided by the incidence of DLTs during the first cycle.	600 mg DKN-01 Part A (Q2W) DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) were met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method was guided by the incidence of DLTs during the first cycle.	300 mg DKN-01 Part B (Q2W) Dose Confirmation: Once the MTD had been established or the highest planned dose level completed, 300 mg of DKN-01 was administered as IV on days 1 and 15 of every 28 day cycle.	Total Total across all treatment groups
Overall Survival (OS) in Patients With Relapsed or Refractory NSCLC	6.6 Months Interval 4.1 to 10.1	—	—	—	—	—

SECONDARY outcome

Timeframe: Part A: Every 2 months; Part B: after 1 month and every two cycles thereafter

Population: All patients with NSCLC who received at least one dose of study treatment during Part A or Part B of the study. One Patients from the 300 mg QW treatment group, and two patients from 300 mg Q2W treatment group did not have assessments performed after Baseline.

For both Parts A and B. Objective response rate is defined as the number of patients with overall best response of complete response (CR) or partial response (PR)

Outcome measures

Outcome measures
Measure	75 Milligram (mg) DKN-01 Part A (QW) n=3 Participants DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) were met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method was guided by the incidence of DLTs during the first cycle.	150 mg DKN-01 Part A (QW) n=3 Participants DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) were met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method will be guided by the incidence of DLTs during the first cycle.	300 mg DKN-01 Part A (QW) n=3 Participants DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) was met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method was guided by the incidence of DLTs during the first cycle.	600 mg DKN-01 Part A (Q2W) n=3 Participants DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) were met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method was guided by the incidence of DLTs during the first cycle.	300 mg DKN-01 Part B (Q2W) n=17 Participants Dose Confirmation: Once the MTD had been established or the highest planned dose level completed, 300 mg of DKN-01 was administered as IV on days 1 and 15 of every 28 day cycle.	Total Total across all treatment groups
Objective Response Rate (ORR) in Oncologic Patients Who Are Refractory or Intolerant to Standard/Approved Therapies	0 Participants Interval 0.0 to 70.8	0 Participants Interval 0.0 to 70.8	0 Participants Interval 0.0 to 60.2	0 Participants Interval 0.0 to 70.8	1 Participants Interval 0.1 to 26.0	—

SECONDARY outcome

Timeframe: Part A: Every 2 months; Part B: after 1 month and every two cycles thereafter

Population: FAS : NSCLC - All patients with NSCLC who received at least one dose of study treatment during Part A or Part B of the study. Two patients in treatment group 300 mg Q2W did not have assessments performed after Baseline.

FAS : For both Parts A and B. Objective response rate is defined as the number of patients with overall best response of complete response (CR) or partial response (PR)

Outcome measures

Outcome measures
Measure	75 Milligram (mg) DKN-01 Part A (QW) n=2 Participants DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) were met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method was guided by the incidence of DLTs during the first cycle.	150 mg DKN-01 Part A (QW) n=1 Participants DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) were met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method will be guided by the incidence of DLTs during the first cycle.	300 mg DKN-01 Part A (QW) DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) was met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method was guided by the incidence of DLTs during the first cycle.	600 mg DKN-01 Part A (Q2W) n=2 Participants DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) were met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method was guided by the incidence of DLTs during the first cycle.	300 mg DKN-01 Part B (Q2W) n=17 Participants Dose Confirmation: Once the MTD had been established or the highest planned dose level completed, 300 mg of DKN-01 was administered as IV on days 1 and 15 of every 28 day cycle.	Total Total across all treatment groups
Objective Response Rate (ORR) in Patients With Relapsed or Refractory Non-small Cell Lung Cancer (NSCLC)	0 participants Interval 0.0 to 84.2	0 participants Interval 0.0 to 97.5	—	0 participants Interval 0.0 to 84.2	1 participants Interval 0.1 to 26.0	—

Adverse Events

75 Milligram (mg) DKN-01 Part A

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

150 mg DKN-01 Part A

Serious events: 2 serious events

Other events: 3 other events

Deaths: 0 deaths

300 mg DKN-01 Part A

Serious events: 1 serious events

Other events: 4 other events

Deaths: 0 deaths

600 mg DKN-01 Part A

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

300 mg DKN-01 Part B

Serious events: 6 serious events

Other events: 16 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	75 Milligram (mg) DKN-01 Part A n=3 participants at risk DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) were met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method was guided by the incidence of DLTs during the first cycle.	150 mg DKN-01 Part A n=3 participants at risk DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) were met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method will be guided by the incidence of DLTs during the first cycle.	300 mg DKN-01 Part A n=4 participants at risk DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) was met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method was guided by the incidence of DLTs during the first cycle.	600 mg DKN-01 Part A n=3 participants at risk DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) were met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method was guided by the incidence of DLTs during the first cycle.	300 mg DKN-01 Part B n=19 participants at risk Dose Confirmation: Once the MTD had been established or the highest planned dose level completed, 300 mg of DKN-01 was administered as IV on days 1 and 15 of every 28 day cycle.
Cardiac disorders CARDIO-RESPIRATORY ARREST	33.3% 1/3 • Number of events 1 • Entirety of the study. 1 year, 3 months. Safety analyses were based on the full analysis set (FAS), which was defined as all patients who received at least one dose of study treatment during Part A or Part B of the study. Assessments up to 30 days after the date of last dose of study medication (for serious adverse events and unresolved study drug-related AEs) were included.	0.00% 0/3 • Entirety of the study. 1 year, 3 months. Safety analyses were based on the full analysis set (FAS), which was defined as all patients who received at least one dose of study treatment during Part A or Part B of the study. Assessments up to 30 days after the date of last dose of study medication (for serious adverse events and unresolved study drug-related AEs) were included.	0.00% 0/4 • Entirety of the study. 1 year, 3 months. Safety analyses were based on the full analysis set (FAS), which was defined as all patients who received at least one dose of study treatment during Part A or Part B of the study. Assessments up to 30 days after the date of last dose of study medication (for serious adverse events and unresolved study drug-related AEs) were included.	0.00% 0/3 • Entirety of the study. 1 year, 3 months. Safety analyses were based on the full analysis set (FAS), which was defined as all patients who received at least one dose of study treatment during Part A or Part B of the study. Assessments up to 30 days after the date of last dose of study medication (for serious adverse events and unresolved study drug-related AEs) were included.	0.00% 0/19 • Entirety of the study. 1 year, 3 months. Safety analyses were based on the full analysis set (FAS), which was defined as all patients who received at least one dose of study treatment during Part A or Part B of the study. Assessments up to 30 days after the date of last dose of study medication (for serious adverse events and unresolved study drug-related AEs) were included.
Gastrointestinal disorders ASCITES	0.00% 0/3 • Entirety of the study. 1 year, 3 months. Safety analyses were based on the full analysis set (FAS), which was defined as all patients who received at least one dose of study treatment during Part A or Part B of the study. Assessments up to 30 days after the date of last dose of study medication (for serious adverse events and unresolved study drug-related AEs) were included.	33.3% 1/3 • Number of events 1 • Entirety of the study. 1 year, 3 months. Safety analyses were based on the full analysis set (FAS), which was defined as all patients who received at least one dose of study treatment during Part A or Part B of the study. Assessments up to 30 days after the date of last dose of study medication (for serious adverse events and unresolved study drug-related AEs) were included.	0.00% 0/4 • Entirety of the study. 1 year, 3 months. Safety analyses were based on the full analysis set (FAS), which was defined as all patients who received at least one dose of study treatment during Part A or Part B of the study. Assessments up to 30 days after the date of last dose of study medication (for serious adverse events and unresolved study drug-related AEs) were included.	0.00% 0/3 • Entirety of the study. 1 year, 3 months. Safety analyses were based on the full analysis set (FAS), which was defined as all patients who received at least one dose of study treatment during Part A or Part B of the study. Assessments up to 30 days after the date of last dose of study medication (for serious adverse events and unresolved study drug-related AEs) were included.	0.00% 0/19 • Entirety of the study. 1 year, 3 months. Safety analyses were based on the full analysis set (FAS), which was defined as all patients who received at least one dose of study treatment during Part A or Part B of the study. Assessments up to 30 days after the date of last dose of study medication (for serious adverse events and unresolved study drug-related AEs) were included.
Gastrointestinal disorders NAUSEA	0.00% 0/3 • Entirety of the study. 1 year, 3 months. Safety analyses were based on the full analysis set (FAS), which was defined as all patients who received at least one dose of study treatment during Part A or Part B of the study. Assessments up to 30 days after the date of last dose of study medication (for serious adverse events and unresolved study drug-related AEs) were included.	33.3% 1/3 • Number of events 1 • Entirety of the study. 1 year, 3 months. Safety analyses were based on the full analysis set (FAS), which was defined as all patients who received at least one dose of study treatment during Part A or Part B of the study. Assessments up to 30 days after the date of last dose of study medication (for serious adverse events and unresolved study drug-related AEs) were included.	25.0% 1/4 • Number of events 1 • Entirety of the study. 1 year, 3 months. Safety analyses were based on the full analysis set (FAS), which was defined as all patients who received at least one dose of study treatment during Part A or Part B of the study. Assessments up to 30 days after the date of last dose of study medication (for serious adverse events and unresolved study drug-related AEs) were included.	0.00% 0/3 • Entirety of the study. 1 year, 3 months. Safety analyses were based on the full analysis set (FAS), which was defined as all patients who received at least one dose of study treatment during Part A or Part B of the study. Assessments up to 30 days after the date of last dose of study medication (for serious adverse events and unresolved study drug-related AEs) were included.	0.00% 0/19 • Entirety of the study. 1 year, 3 months. Safety analyses were based on the full analysis set (FAS), which was defined as all patients who received at least one dose of study treatment during Part A or Part B of the study. Assessments up to 30 days after the date of last dose of study medication (for serious adverse events and unresolved study drug-related AEs) were included.
Gastrointestinal disorders VOMITING	0.00% 0/3 • Entirety of the study. 1 year, 3 months. Safety analyses were based on the full analysis set (FAS), which was defined as all patients who received at least one dose of study treatment during Part A or Part B of the study. Assessments up to 30 days after the date of last dose of study medication (for serious adverse events and unresolved study drug-related AEs) were included.	33.3% 1/3 • Number of events 1 • Entirety of the study. 1 year, 3 months. Safety analyses were based on the full analysis set (FAS), which was defined as all patients who received at least one dose of study treatment during Part A or Part B of the study. Assessments up to 30 days after the date of last dose of study medication (for serious adverse events and unresolved study drug-related AEs) were included.	25.0% 1/4 • Number of events 1 • Entirety of the study. 1 year, 3 months. Safety analyses were based on the full analysis set (FAS), which was defined as all patients who received at least one dose of study treatment during Part A or Part B of the study. Assessments up to 30 days after the date of last dose of study medication (for serious adverse events and unresolved study drug-related AEs) were included.	0.00% 0/3 • Entirety of the study. 1 year, 3 months. Safety analyses were based on the full analysis set (FAS), which was defined as all patients who received at least one dose of study treatment during Part A or Part B of the study. Assessments up to 30 days after the date of last dose of study medication (for serious adverse events and unresolved study drug-related AEs) were included.	5.3% 1/19 • Number of events 1 • Entirety of the study. 1 year, 3 months. Safety analyses were based on the full analysis set (FAS), which was defined as all patients who received at least one dose of study treatment during Part A or Part B of the study. Assessments up to 30 days after the date of last dose of study medication (for serious adverse events and unresolved study drug-related AEs) were included.
Cardiac disorders ATRIAL FIBRILLATION	0.00% 0/3 • Entirety of the study. 1 year, 3 months. Safety analyses were based on the full analysis set (FAS), which was defined as all patients who received at least one dose of study treatment during Part A or Part B of the study. Assessments up to 30 days after the date of last dose of study medication (for serious adverse events and unresolved study drug-related AEs) were included.	33.3% 1/3 • Number of events 1 • Entirety of the study. 1 year, 3 months. Safety analyses were based on the full analysis set (FAS), which was defined as all patients who received at least one dose of study treatment during Part A or Part B of the study. Assessments up to 30 days after the date of last dose of study medication (for serious adverse events and unresolved study drug-related AEs) were included.	0.00% 0/4 • Entirety of the study. 1 year, 3 months. Safety analyses were based on the full analysis set (FAS), which was defined as all patients who received at least one dose of study treatment during Part A or Part B of the study. Assessments up to 30 days after the date of last dose of study medication (for serious adverse events and unresolved study drug-related AEs) were included.	0.00% 0/3 • Entirety of the study. 1 year, 3 months. Safety analyses were based on the full analysis set (FAS), which was defined as all patients who received at least one dose of study treatment during Part A or Part B of the study. Assessments up to 30 days after the date of last dose of study medication (for serious adverse events and unresolved study drug-related AEs) were included.	5.3% 1/19 • Number of events 1 • Entirety of the study. 1 year, 3 months. Safety analyses were based on the full analysis set (FAS), which was defined as all patients who received at least one dose of study treatment during Part A or Part B of the study. Assessments up to 30 days after the date of last dose of study medication (for serious adverse events and unresolved study drug-related AEs) were included.
Surgical and medical procedures PAIN MANAGEMENT	0.00% 0/3 • Entirety of the study. 1 year, 3 months. Safety analyses were based on the full analysis set (FAS), which was defined as all patients who received at least one dose of study treatment during Part A or Part B of the study. Assessments up to 30 days after the date of last dose of study medication (for serious adverse events and unresolved study drug-related AEs) were included.	0.00% 0/3 • Entirety of the study. 1 year, 3 months. Safety analyses were based on the full analysis set (FAS), which was defined as all patients who received at least one dose of study treatment during Part A or Part B of the study. Assessments up to 30 days after the date of last dose of study medication (for serious adverse events and unresolved study drug-related AEs) were included.	25.0% 1/4 • Number of events 1 • Entirety of the study. 1 year, 3 months. Safety analyses were based on the full analysis set (FAS), which was defined as all patients who received at least one dose of study treatment during Part A or Part B of the study. Assessments up to 30 days after the date of last dose of study medication (for serious adverse events and unresolved study drug-related AEs) were included.	0.00% 0/3 • Entirety of the study. 1 year, 3 months. Safety analyses were based on the full analysis set (FAS), which was defined as all patients who received at least one dose of study treatment during Part A or Part B of the study. Assessments up to 30 days after the date of last dose of study medication (for serious adverse events and unresolved study drug-related AEs) were included.	0.00% 0/19 • Entirety of the study. 1 year, 3 months. Safety analyses were based on the full analysis set (FAS), which was defined as all patients who received at least one dose of study treatment during Part A or Part B of the study. Assessments up to 30 days after the date of last dose of study medication (for serious adverse events and unresolved study drug-related AEs) were included.
Respiratory, thoracic and mediastinal disorders PLEURAL EFFUSION	0.00% 0/3 • Entirety of the study. 1 year, 3 months. Safety analyses were based on the full analysis set (FAS), which was defined as all patients who received at least one dose of study treatment during Part A or Part B of the study. Assessments up to 30 days after the date of last dose of study medication (for serious adverse events and unresolved study drug-related AEs) were included.	0.00% 0/3 • Entirety of the study. 1 year, 3 months. Safety analyses were based on the full analysis set (FAS), which was defined as all patients who received at least one dose of study treatment during Part A or Part B of the study. Assessments up to 30 days after the date of last dose of study medication (for serious adverse events and unresolved study drug-related AEs) were included.	0.00% 0/4 • Entirety of the study. 1 year, 3 months. Safety analyses were based on the full analysis set (FAS), which was defined as all patients who received at least one dose of study treatment during Part A or Part B of the study. Assessments up to 30 days after the date of last dose of study medication (for serious adverse events and unresolved study drug-related AEs) were included.	0.00% 0/3 • Entirety of the study. 1 year, 3 months. Safety analyses were based on the full analysis set (FAS), which was defined as all patients who received at least one dose of study treatment during Part A or Part B of the study. Assessments up to 30 days after the date of last dose of study medication (for serious adverse events and unresolved study drug-related AEs) were included.	5.3% 1/19 • Number of events 1 • Entirety of the study. 1 year, 3 months. Safety analyses were based on the full analysis set (FAS), which was defined as all patients who received at least one dose of study treatment during Part A or Part B of the study. Assessments up to 30 days after the date of last dose of study medication (for serious adverse events and unresolved study drug-related AEs) were included.
Infections and infestations PNEUMONIA	0.00% 0/3 • Entirety of the study. 1 year, 3 months. Safety analyses were based on the full analysis set (FAS), which was defined as all patients who received at least one dose of study treatment during Part A or Part B of the study. Assessments up to 30 days after the date of last dose of study medication (for serious adverse events and unresolved study drug-related AEs) were included.	0.00% 0/3 • Entirety of the study. 1 year, 3 months. Safety analyses were based on the full analysis set (FAS), which was defined as all patients who received at least one dose of study treatment during Part A or Part B of the study. Assessments up to 30 days after the date of last dose of study medication (for serious adverse events and unresolved study drug-related AEs) were included.	0.00% 0/4 • Entirety of the study. 1 year, 3 months. Safety analyses were based on the full analysis set (FAS), which was defined as all patients who received at least one dose of study treatment during Part A or Part B of the study. Assessments up to 30 days after the date of last dose of study medication (for serious adverse events and unresolved study drug-related AEs) were included.	0.00% 0/3 • Entirety of the study. 1 year, 3 months. Safety analyses were based on the full analysis set (FAS), which was defined as all patients who received at least one dose of study treatment during Part A or Part B of the study. Assessments up to 30 days after the date of last dose of study medication (for serious adverse events and unresolved study drug-related AEs) were included.	15.8% 3/19 • Number of events 3 • Entirety of the study. 1 year, 3 months. Safety analyses were based on the full analysis set (FAS), which was defined as all patients who received at least one dose of study treatment during Part A or Part B of the study. Assessments up to 30 days after the date of last dose of study medication (for serious adverse events and unresolved study drug-related AEs) were included.
Respiratory, thoracic and mediastinal disorders PULMONARY EMBOLISM	0.00% 0/3 • Entirety of the study. 1 year, 3 months. Safety analyses were based on the full analysis set (FAS), which was defined as all patients who received at least one dose of study treatment during Part A or Part B of the study. Assessments up to 30 days after the date of last dose of study medication (for serious adverse events and unresolved study drug-related AEs) were included.	0.00% 0/3 • Entirety of the study. 1 year, 3 months. Safety analyses were based on the full analysis set (FAS), which was defined as all patients who received at least one dose of study treatment during Part A or Part B of the study. Assessments up to 30 days after the date of last dose of study medication (for serious adverse events and unresolved study drug-related AEs) were included.	0.00% 0/4 • Entirety of the study. 1 year, 3 months. Safety analyses were based on the full analysis set (FAS), which was defined as all patients who received at least one dose of study treatment during Part A or Part B of the study. Assessments up to 30 days after the date of last dose of study medication (for serious adverse events and unresolved study drug-related AEs) were included.	0.00% 0/3 • Entirety of the study. 1 year, 3 months. Safety analyses were based on the full analysis set (FAS), which was defined as all patients who received at least one dose of study treatment during Part A or Part B of the study. Assessments up to 30 days after the date of last dose of study medication (for serious adverse events and unresolved study drug-related AEs) were included.	5.3% 1/19 • Number of events 1 • Entirety of the study. 1 year, 3 months. Safety analyses were based on the full analysis set (FAS), which was defined as all patients who received at least one dose of study treatment during Part A or Part B of the study. Assessments up to 30 days after the date of last dose of study medication (for serious adverse events and unresolved study drug-related AEs) were included.
Respiratory, thoracic and mediastinal disorders RESPIRATORY FAILURE	0.00% 0/3 • Entirety of the study. 1 year, 3 months. Safety analyses were based on the full analysis set (FAS), which was defined as all patients who received at least one dose of study treatment during Part A or Part B of the study. Assessments up to 30 days after the date of last dose of study medication (for serious adverse events and unresolved study drug-related AEs) were included.	0.00% 0/3 • Entirety of the study. 1 year, 3 months. Safety analyses were based on the full analysis set (FAS), which was defined as all patients who received at least one dose of study treatment during Part A or Part B of the study. Assessments up to 30 days after the date of last dose of study medication (for serious adverse events and unresolved study drug-related AEs) were included.	0.00% 0/4 • Entirety of the study. 1 year, 3 months. Safety analyses were based on the full analysis set (FAS), which was defined as all patients who received at least one dose of study treatment during Part A or Part B of the study. Assessments up to 30 days after the date of last dose of study medication (for serious adverse events and unresolved study drug-related AEs) were included.	0.00% 0/3 • Entirety of the study. 1 year, 3 months. Safety analyses were based on the full analysis set (FAS), which was defined as all patients who received at least one dose of study treatment during Part A or Part B of the study. Assessments up to 30 days after the date of last dose of study medication (for serious adverse events and unresolved study drug-related AEs) were included.	5.3% 1/19 • Number of events 1 • Entirety of the study. 1 year, 3 months. Safety analyses were based on the full analysis set (FAS), which was defined as all patients who received at least one dose of study treatment during Part A or Part B of the study. Assessments up to 30 days after the date of last dose of study medication (for serious adverse events and unresolved study drug-related AEs) were included.
Vascular disorders SUPERIOR VENA CAVA SYNDROME	0.00% 0/3 • Entirety of the study. 1 year, 3 months. Safety analyses were based on the full analysis set (FAS), which was defined as all patients who received at least one dose of study treatment during Part A or Part B of the study. Assessments up to 30 days after the date of last dose of study medication (for serious adverse events and unresolved study drug-related AEs) were included.	0.00% 0/3 • Entirety of the study. 1 year, 3 months. Safety analyses were based on the full analysis set (FAS), which was defined as all patients who received at least one dose of study treatment during Part A or Part B of the study. Assessments up to 30 days after the date of last dose of study medication (for serious adverse events and unresolved study drug-related AEs) were included.	0.00% 0/4 • Entirety of the study. 1 year, 3 months. Safety analyses were based on the full analysis set (FAS), which was defined as all patients who received at least one dose of study treatment during Part A or Part B of the study. Assessments up to 30 days after the date of last dose of study medication (for serious adverse events and unresolved study drug-related AEs) were included.	0.00% 0/3 • Entirety of the study. 1 year, 3 months. Safety analyses were based on the full analysis set (FAS), which was defined as all patients who received at least one dose of study treatment during Part A or Part B of the study. Assessments up to 30 days after the date of last dose of study medication (for serious adverse events and unresolved study drug-related AEs) were included.	5.3% 1/19 • Number of events 1 • Entirety of the study. 1 year, 3 months. Safety analyses were based on the full analysis set (FAS), which was defined as all patients who received at least one dose of study treatment during Part A or Part B of the study. Assessments up to 30 days after the date of last dose of study medication (for serious adverse events and unresolved study drug-related AEs) were included.
Cardiac disorders PERICARDIAL EFFUSION	0.00% 0/3 • Entirety of the study. 1 year, 3 months. Safety analyses were based on the full analysis set (FAS), which was defined as all patients who received at least one dose of study treatment during Part A or Part B of the study. Assessments up to 30 days after the date of last dose of study medication (for serious adverse events and unresolved study drug-related AEs) were included.	33.3% 1/3 • Number of events 1 • Entirety of the study. 1 year, 3 months. Safety analyses were based on the full analysis set (FAS), which was defined as all patients who received at least one dose of study treatment during Part A or Part B of the study. Assessments up to 30 days after the date of last dose of study medication (for serious adverse events and unresolved study drug-related AEs) were included.	0.00% 0/4 • Entirety of the study. 1 year, 3 months. Safety analyses were based on the full analysis set (FAS), which was defined as all patients who received at least one dose of study treatment during Part A or Part B of the study. Assessments up to 30 days after the date of last dose of study medication (for serious adverse events and unresolved study drug-related AEs) were included.	0.00% 0/3 • Entirety of the study. 1 year, 3 months. Safety analyses were based on the full analysis set (FAS), which was defined as all patients who received at least one dose of study treatment during Part A or Part B of the study. Assessments up to 30 days after the date of last dose of study medication (for serious adverse events and unresolved study drug-related AEs) were included.	0.00% 0/19 • Entirety of the study. 1 year, 3 months. Safety analyses were based on the full analysis set (FAS), which was defined as all patients who received at least one dose of study treatment during Part A or Part B of the study. Assessments up to 30 days after the date of last dose of study medication (for serious adverse events and unresolved study drug-related AEs) were included.

Other adverse events

Other adverse events
Measure	75 Milligram (mg) DKN-01 Part A n=3 participants at risk DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) were met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method was guided by the incidence of DLTs during the first cycle.	150 mg DKN-01 Part A n=3 participants at risk DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) were met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method will be guided by the incidence of DLTs during the first cycle.	300 mg DKN-01 Part A n=4 participants at risk DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) was met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method was guided by the incidence of DLTs during the first cycle.	600 mg DKN-01 Part A n=3 participants at risk DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) were met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method was guided by the incidence of DLTs during the first cycle.	300 mg DKN-01 Part B n=19 participants at risk Dose Confirmation: Once the MTD had been established or the highest planned dose level completed, 300 mg of DKN-01 was administered as IV on days 1 and 15 of every 28 day cycle.
Gastrointestinal disorders NAUSEA	33.3% 1/3 • Entirety of the study. 1 year, 3 months. Safety analyses were based on the full analysis set (FAS), which was defined as all patients who received at least one dose of study treatment during Part A or Part B of the study. Assessments up to 30 days after the date of last dose of study medication (for serious adverse events and unresolved study drug-related AEs) were included.	66.7% 2/3 • Entirety of the study. 1 year, 3 months. Safety analyses were based on the full analysis set (FAS), which was defined as all patients who received at least one dose of study treatment during Part A or Part B of the study. Assessments up to 30 days after the date of last dose of study medication (for serious adverse events and unresolved study drug-related AEs) were included.	50.0% 2/4 • Entirety of the study. 1 year, 3 months. Safety analyses were based on the full analysis set (FAS), which was defined as all patients who received at least one dose of study treatment during Part A or Part B of the study. Assessments up to 30 days after the date of last dose of study medication (for serious adverse events and unresolved study drug-related AEs) were included.	33.3% 1/3 • Entirety of the study. 1 year, 3 months. Safety analyses were based on the full analysis set (FAS), which was defined as all patients who received at least one dose of study treatment during Part A or Part B of the study. Assessments up to 30 days after the date of last dose of study medication (for serious adverse events and unresolved study drug-related AEs) were included.	21.1% 4/19 • Entirety of the study. 1 year, 3 months. Safety analyses were based on the full analysis set (FAS), which was defined as all patients who received at least one dose of study treatment during Part A or Part B of the study. Assessments up to 30 days after the date of last dose of study medication (for serious adverse events and unresolved study drug-related AEs) were included.
General disorders FATIGUE	0.00% 0/3 • Entirety of the study. 1 year, 3 months. Safety analyses were based on the full analysis set (FAS), which was defined as all patients who received at least one dose of study treatment during Part A or Part B of the study. Assessments up to 30 days after the date of last dose of study medication (for serious adverse events and unresolved study drug-related AEs) were included.	66.7% 2/3 • Entirety of the study. 1 year, 3 months. Safety analyses were based on the full analysis set (FAS), which was defined as all patients who received at least one dose of study treatment during Part A or Part B of the study. Assessments up to 30 days after the date of last dose of study medication (for serious adverse events and unresolved study drug-related AEs) were included.	75.0% 3/4 • Entirety of the study. 1 year, 3 months. Safety analyses were based on the full analysis set (FAS), which was defined as all patients who received at least one dose of study treatment during Part A or Part B of the study. Assessments up to 30 days after the date of last dose of study medication (for serious adverse events and unresolved study drug-related AEs) were included.	0.00% 0/3 • Entirety of the study. 1 year, 3 months. Safety analyses were based on the full analysis set (FAS), which was defined as all patients who received at least one dose of study treatment during Part A or Part B of the study. Assessments up to 30 days after the date of last dose of study medication (for serious adverse events and unresolved study drug-related AEs) were included.	21.1% 4/19 • Entirety of the study. 1 year, 3 months. Safety analyses were based on the full analysis set (FAS), which was defined as all patients who received at least one dose of study treatment during Part A or Part B of the study. Assessments up to 30 days after the date of last dose of study medication (for serious adverse events and unresolved study drug-related AEs) were included.
Metabolism and nutrition disorders DECREASED APPETITE	33.3% 1/3 • Entirety of the study. 1 year, 3 months. Safety analyses were based on the full analysis set (FAS), which was defined as all patients who received at least one dose of study treatment during Part A or Part B of the study. Assessments up to 30 days after the date of last dose of study medication (for serious adverse events and unresolved study drug-related AEs) were included.	33.3% 1/3 • Entirety of the study. 1 year, 3 months. Safety analyses were based on the full analysis set (FAS), which was defined as all patients who received at least one dose of study treatment during Part A or Part B of the study. Assessments up to 30 days after the date of last dose of study medication (for serious adverse events and unresolved study drug-related AEs) were included.	25.0% 1/4 • Entirety of the study. 1 year, 3 months. Safety analyses were based on the full analysis set (FAS), which was defined as all patients who received at least one dose of study treatment during Part A or Part B of the study. Assessments up to 30 days after the date of last dose of study medication (for serious adverse events and unresolved study drug-related AEs) were included.	33.3% 1/3 • Entirety of the study. 1 year, 3 months. Safety analyses were based on the full analysis set (FAS), which was defined as all patients who received at least one dose of study treatment during Part A or Part B of the study. Assessments up to 30 days after the date of last dose of study medication (for serious adverse events and unresolved study drug-related AEs) were included.	21.1% 4/19 • Entirety of the study. 1 year, 3 months. Safety analyses were based on the full analysis set (FAS), which was defined as all patients who received at least one dose of study treatment during Part A or Part B of the study. Assessments up to 30 days after the date of last dose of study medication (for serious adverse events and unresolved study drug-related AEs) were included.
Respiratory, thoracic and mediastinal disorders DYSPNOEA	0.00% 0/3 • Entirety of the study. 1 year, 3 months. Safety analyses were based on the full analysis set (FAS), which was defined as all patients who received at least one dose of study treatment during Part A or Part B of the study. Assessments up to 30 days after the date of last dose of study medication (for serious adverse events and unresolved study drug-related AEs) were included.	33.3% 1/3 • Entirety of the study. 1 year, 3 months. Safety analyses were based on the full analysis set (FAS), which was defined as all patients who received at least one dose of study treatment during Part A or Part B of the study. Assessments up to 30 days after the date of last dose of study medication (for serious adverse events and unresolved study drug-related AEs) were included.	0.00% 0/4 • Entirety of the study. 1 year, 3 months. Safety analyses were based on the full analysis set (FAS), which was defined as all patients who received at least one dose of study treatment during Part A or Part B of the study. Assessments up to 30 days after the date of last dose of study medication (for serious adverse events and unresolved study drug-related AEs) were included.	0.00% 0/3 • Entirety of the study. 1 year, 3 months. Safety analyses were based on the full analysis set (FAS), which was defined as all patients who received at least one dose of study treatment during Part A or Part B of the study. Assessments up to 30 days after the date of last dose of study medication (for serious adverse events and unresolved study drug-related AEs) were included.	31.6% 6/19 • Entirety of the study. 1 year, 3 months. Safety analyses were based on the full analysis set (FAS), which was defined as all patients who received at least one dose of study treatment during Part A or Part B of the study. Assessments up to 30 days after the date of last dose of study medication (for serious adverse events and unresolved study drug-related AEs) were included.
Gastrointestinal disorders VOMITTING	33.3% 1/3 • Entirety of the study. 1 year, 3 months. Safety analyses were based on the full analysis set (FAS), which was defined as all patients who received at least one dose of study treatment during Part A or Part B of the study. Assessments up to 30 days after the date of last dose of study medication (for serious adverse events and unresolved study drug-related AEs) were included.	66.7% 2/3 • Entirety of the study. 1 year, 3 months. Safety analyses were based on the full analysis set (FAS), which was defined as all patients who received at least one dose of study treatment during Part A or Part B of the study. Assessments up to 30 days after the date of last dose of study medication (for serious adverse events and unresolved study drug-related AEs) were included.	25.0% 1/4 • Entirety of the study. 1 year, 3 months. Safety analyses were based on the full analysis set (FAS), which was defined as all patients who received at least one dose of study treatment during Part A or Part B of the study. Assessments up to 30 days after the date of last dose of study medication (for serious adverse events and unresolved study drug-related AEs) were included.	33.3% 1/3 • Entirety of the study. 1 year, 3 months. Safety analyses were based on the full analysis set (FAS), which was defined as all patients who received at least one dose of study treatment during Part A or Part B of the study. Assessments up to 30 days after the date of last dose of study medication (for serious adverse events and unresolved study drug-related AEs) were included.	10.5% 2/19 • Entirety of the study. 1 year, 3 months. Safety analyses were based on the full analysis set (FAS), which was defined as all patients who received at least one dose of study treatment during Part A or Part B of the study. Assessments up to 30 days after the date of last dose of study medication (for serious adverse events and unresolved study drug-related AEs) were included.
Gastrointestinal disorders CONSTIPATION	66.7% 2/3 • Entirety of the study. 1 year, 3 months. Safety analyses were based on the full analysis set (FAS), which was defined as all patients who received at least one dose of study treatment during Part A or Part B of the study. Assessments up to 30 days after the date of last dose of study medication (for serious adverse events and unresolved study drug-related AEs) were included.	33.3% 1/3 • Entirety of the study. 1 year, 3 months. Safety analyses were based on the full analysis set (FAS), which was defined as all patients who received at least one dose of study treatment during Part A or Part B of the study. Assessments up to 30 days after the date of last dose of study medication (for serious adverse events and unresolved study drug-related AEs) were included.	25.0% 1/4 • Entirety of the study. 1 year, 3 months. Safety analyses were based on the full analysis set (FAS), which was defined as all patients who received at least one dose of study treatment during Part A or Part B of the study. Assessments up to 30 days after the date of last dose of study medication (for serious adverse events and unresolved study drug-related AEs) were included.	0.00% 0/3 • Entirety of the study. 1 year, 3 months. Safety analyses were based on the full analysis set (FAS), which was defined as all patients who received at least one dose of study treatment during Part A or Part B of the study. Assessments up to 30 days after the date of last dose of study medication (for serious adverse events and unresolved study drug-related AEs) were included.	10.5% 2/19 • Entirety of the study. 1 year, 3 months. Safety analyses were based on the full analysis set (FAS), which was defined as all patients who received at least one dose of study treatment during Part A or Part B of the study. Assessments up to 30 days after the date of last dose of study medication (for serious adverse events and unresolved study drug-related AEs) were included.
General disorders ASTHENIA	33.3% 1/3 • Entirety of the study. 1 year, 3 months. Safety analyses were based on the full analysis set (FAS), which was defined as all patients who received at least one dose of study treatment during Part A or Part B of the study. Assessments up to 30 days after the date of last dose of study medication (for serious adverse events and unresolved study drug-related AEs) were included.	33.3% 1/3 • Entirety of the study. 1 year, 3 months. Safety analyses were based on the full analysis set (FAS), which was defined as all patients who received at least one dose of study treatment during Part A or Part B of the study. Assessments up to 30 days after the date of last dose of study medication (for serious adverse events and unresolved study drug-related AEs) were included.	25.0% 1/4 • Entirety of the study. 1 year, 3 months. Safety analyses were based on the full analysis set (FAS), which was defined as all patients who received at least one dose of study treatment during Part A or Part B of the study. Assessments up to 30 days after the date of last dose of study medication (for serious adverse events and unresolved study drug-related AEs) were included.	0.00% 0/3 • Entirety of the study. 1 year, 3 months. Safety analyses were based on the full analysis set (FAS), which was defined as all patients who received at least one dose of study treatment during Part A or Part B of the study. Assessments up to 30 days after the date of last dose of study medication (for serious adverse events and unresolved study drug-related AEs) were included.	5.3% 1/19 • Entirety of the study. 1 year, 3 months. Safety analyses were based on the full analysis set (FAS), which was defined as all patients who received at least one dose of study treatment during Part A or Part B of the study. Assessments up to 30 days after the date of last dose of study medication (for serious adverse events and unresolved study drug-related AEs) were included.
Gastrointestinal disorders DYSPHAGIA	33.3% 1/3 • Entirety of the study. 1 year, 3 months. Safety analyses were based on the full analysis set (FAS), which was defined as all patients who received at least one dose of study treatment during Part A or Part B of the study. Assessments up to 30 days after the date of last dose of study medication (for serious adverse events and unresolved study drug-related AEs) were included.	66.7% 2/3 • Entirety of the study. 1 year, 3 months. Safety analyses were based on the full analysis set (FAS), which was defined as all patients who received at least one dose of study treatment during Part A or Part B of the study. Assessments up to 30 days after the date of last dose of study medication (for serious adverse events and unresolved study drug-related AEs) were included.	0.00% 0/4 • Entirety of the study. 1 year, 3 months. Safety analyses were based on the full analysis set (FAS), which was defined as all patients who received at least one dose of study treatment during Part A or Part B of the study. Assessments up to 30 days after the date of last dose of study medication (for serious adverse events and unresolved study drug-related AEs) were included.	0.00% 0/3 • Entirety of the study. 1 year, 3 months. Safety analyses were based on the full analysis set (FAS), which was defined as all patients who received at least one dose of study treatment during Part A or Part B of the study. Assessments up to 30 days after the date of last dose of study medication (for serious adverse events and unresolved study drug-related AEs) were included.	5.3% 1/19 • Entirety of the study. 1 year, 3 months. Safety analyses were based on the full analysis set (FAS), which was defined as all patients who received at least one dose of study treatment during Part A or Part B of the study. Assessments up to 30 days after the date of last dose of study medication (for serious adverse events and unresolved study drug-related AEs) were included.
Metabolism and nutrition disorders HYPOKALAEMIA	0.00% 0/3 • Entirety of the study. 1 year, 3 months. Safety analyses were based on the full analysis set (FAS), which was defined as all patients who received at least one dose of study treatment during Part A or Part B of the study. Assessments up to 30 days after the date of last dose of study medication (for serious adverse events and unresolved study drug-related AEs) were included.	66.7% 2/3 • Entirety of the study. 1 year, 3 months. Safety analyses were based on the full analysis set (FAS), which was defined as all patients who received at least one dose of study treatment during Part A or Part B of the study. Assessments up to 30 days after the date of last dose of study medication (for serious adverse events and unresolved study drug-related AEs) were included.	0.00% 0/4 • Entirety of the study. 1 year, 3 months. Safety analyses were based on the full analysis set (FAS), which was defined as all patients who received at least one dose of study treatment during Part A or Part B of the study. Assessments up to 30 days after the date of last dose of study medication (for serious adverse events and unresolved study drug-related AEs) were included.	0.00% 0/3 • Entirety of the study. 1 year, 3 months. Safety analyses were based on the full analysis set (FAS), which was defined as all patients who received at least one dose of study treatment during Part A or Part B of the study. Assessments up to 30 days after the date of last dose of study medication (for serious adverse events and unresolved study drug-related AEs) were included.	10.5% 2/19 • Entirety of the study. 1 year, 3 months. Safety analyses were based on the full analysis set (FAS), which was defined as all patients who received at least one dose of study treatment during Part A or Part B of the study. Assessments up to 30 days after the date of last dose of study medication (for serious adverse events and unresolved study drug-related AEs) were included.
Respiratory, thoracic and mediastinal disorders PNEUMONIA	33.3% 1/3 • Entirety of the study. 1 year, 3 months. Safety analyses were based on the full analysis set (FAS), which was defined as all patients who received at least one dose of study treatment during Part A or Part B of the study. Assessments up to 30 days after the date of last dose of study medication (for serious adverse events and unresolved study drug-related AEs) were included.	0.00% 0/3 • Entirety of the study. 1 year, 3 months. Safety analyses were based on the full analysis set (FAS), which was defined as all patients who received at least one dose of study treatment during Part A or Part B of the study. Assessments up to 30 days after the date of last dose of study medication (for serious adverse events and unresolved study drug-related AEs) were included.	0.00% 0/4 • Entirety of the study. 1 year, 3 months. Safety analyses were based on the full analysis set (FAS), which was defined as all patients who received at least one dose of study treatment during Part A or Part B of the study. Assessments up to 30 days after the date of last dose of study medication (for serious adverse events and unresolved study drug-related AEs) were included.	0.00% 0/3 • Entirety of the study. 1 year, 3 months. Safety analyses were based on the full analysis set (FAS), which was defined as all patients who received at least one dose of study treatment during Part A or Part B of the study. Assessments up to 30 days after the date of last dose of study medication (for serious adverse events and unresolved study drug-related AEs) were included.	15.8% 3/19 • Entirety of the study. 1 year, 3 months. Safety analyses were based on the full analysis set (FAS), which was defined as all patients who received at least one dose of study treatment during Part A or Part B of the study. Assessments up to 30 days after the date of last dose of study medication (for serious adverse events and unresolved study drug-related AEs) were included.
Respiratory, thoracic and mediastinal disorders PRODUCTIVE COUGH	33.3% 1/3 • Entirety of the study. 1 year, 3 months. Safety analyses were based on the full analysis set (FAS), which was defined as all patients who received at least one dose of study treatment during Part A or Part B of the study. Assessments up to 30 days after the date of last dose of study medication (for serious adverse events and unresolved study drug-related AEs) were included.	0.00% 0/3 • Entirety of the study. 1 year, 3 months. Safety analyses were based on the full analysis set (FAS), which was defined as all patients who received at least one dose of study treatment during Part A or Part B of the study. Assessments up to 30 days after the date of last dose of study medication (for serious adverse events and unresolved study drug-related AEs) were included.	0.00% 0/4 • Entirety of the study. 1 year, 3 months. Safety analyses were based on the full analysis set (FAS), which was defined as all patients who received at least one dose of study treatment during Part A or Part B of the study. Assessments up to 30 days after the date of last dose of study medication (for serious adverse events and unresolved study drug-related AEs) were included.	0.00% 0/3 • Entirety of the study. 1 year, 3 months. Safety analyses were based on the full analysis set (FAS), which was defined as all patients who received at least one dose of study treatment during Part A or Part B of the study. Assessments up to 30 days after the date of last dose of study medication (for serious adverse events and unresolved study drug-related AEs) were included.	15.8% 3/19 • Entirety of the study. 1 year, 3 months. Safety analyses were based on the full analysis set (FAS), which was defined as all patients who received at least one dose of study treatment during Part A or Part B of the study. Assessments up to 30 days after the date of last dose of study medication (for serious adverse events and unresolved study drug-related AEs) were included.

Additional Information

Cynthia Sirard, MD

Healthcare Pharmaceuticals, Inc

Phone: 617-714-0357

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Publication of the results shall not be made before the publication by Sponsor. If there is no multi-site publication within 18 months after the Study completion/termination at all sites, the Site shall have the right to publish its results. Prior to submitting to public release the Sponsor has 60 days from receipt to review and comment. The Site shall, upon Sponsor's request, further delay publication/presentation for up to 120 days to allow Sponsor to protect its interests.
Publication restrictions are in place

Restriction type: OTHER