Trial Outcomes & Findings for Nab-Sirolimus in Combination With FOLFOX & BEV as 1st Line Therapy in Patients With Advanced or Metastatic Colorectal Cancer (NCT NCT03439462)

Last Updated: 2024-01-02

Results Overview

Dose-limiting-toxicities within the first 2 cycles of treatment with nab-sirolimus at various doses and schedule in combination with mFOLFOX6 and bevacizumab

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

60 participants

Primary outcome timeframe

First 2 treatment cycles (2 months)

Results posted on

2024-01-02

Participant Flow

Participant milestones

Participant milestones
Measure	Dose Cohort 1: Nab-Sirolimus 30 mg/m2 qw3/4 Dose / Schedule Cohort 1: nab-Sirolimus: 30 mg/m2 weekly on Days 1, 8, and 15 (28-day cycle) by IV Modified FOLFOX6 regimen: oxaliplatin 85 mg/m2 IV with LV 400 mg/m2 IV plus FU 400 mg/m2 IV bolus and 2,400 mg/m2 continuous infusion over 46 hours every 2 weeks Bevacizumab: 5 mg/kg IV every 2 weeks	Cohort 2: Nab-Sirolimus 20 mg/m2 qw3/4 Dose / Schedule Cohort 2: nab-Sirolimus: 20 mg/m2 weekly on Days 1, 8, and 15 (28-day cycle) by IV Modified FOLFOX6 regimen: oxaliplatin 85 mg/m2 IV with LV 400 mg/m2 IV over 2 hours plus FU 400 mg/m2 IV bolus and 2,400 mg/m2 continuous infusion over 46 hours every 2 weeks Bevacizumab: 5 mg/kg IV every 2 weeks	Cohort 3: Nab-Sirolimus 20 mg/m2 qw2/4 Dose / Schedule Cohort 3 (Recommended Phase 2 Dose, RP2D): nab-Sirolimus: 20 mg/m2 every 2 weeks (28-day cycle) by IV Modified FOLFOX6 regimen: oxaliplatin 85 mg/m2 IV with LV 400 mg/m2 IV over 2 hours plus FU 400 mg/m2 IV bolus and 2,400 mg/m2 continuous infusion over 46 hours every 2 weeks Bevacizumab: 5 mg/kg IV every 2 weeks
Overall Study STARTED	6	10	44
Overall Study COMPLETED	6	10	44
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Nab-Sirolimus in Combination With FOLFOX & BEV as 1st Line Therapy in Patients With Advanced or Metastatic Colorectal Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cohort 1: Nab-Sirolimus 30 mg/m2 qw3/4 n=6 Participants Dose /Schedule Cohort 1: nab-Sirolimus: 30 mg/m2 weekly on Days 1, 8, and 15 (28-day cycle) by IV Modified FOLFOX6 regimen: oxaliplatin 85 mg/m2 IV with LV 400 mg/m2 IV over 2 hours plus FU 400 mg/m2 IV bolus and 2,400 mg/m2 continuous infusion over 46 hours every 2 weeks Bevacizumab: 5 mg/kg IV every 2 weeks	Cohort 1: Nab-Sirolimus 20 mg/m2 qw3/4 n=10 Participants Dose /Schedule Cohort 2: nab-Sirolimus: 20 mg/m2 weekly on Days 1, 8, and 15 (28-day cycle) by IV Modified FOLFOX6 regimen: oxaliplatin 85 mg/m2 IV with LV 400 mg/m2 IV over 2 hours plus FU 400 mg/m2 IV bolus and 2,400 mg/m2 continuous infusion over 46 hours every 2 weeks. Bevacizumab: 5 mg/kg IV every 2 weeks	Cohort 2: Nab-Sirolimus 20 mg/m2 qw2/4 n=44 Participants Dose /Schedule Cohort 3: (Recommended Phase 2 Dose, RP2D): nab-Sirolimus: 20 mg/m2 every 2 weeks (28-day cycle) by IV. Modified FOLFOX6 regimen: oxaliplatin 85 mg/m2 IV with LV 400 mg/m2 IV over 2 hours plus FU 400 mg/m2 IV bolus and 2,400 mg/m2 continuous infusion over 46 hours every 2 weeks Bevacizumab: 5 mg/kg IV every 2 weeks	Total n=60 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=5 Participants	9 Participants n=7 Participants	34 Participants n=5 Participants	47 Participants n=4 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants	1 Participants n=7 Participants	10 Participants n=5 Participants	13 Participants n=4 Participants
Age, Continuous	61.5 Years n=5 Participants	46.0 Years n=7 Participants	51.0 Years n=5 Participants	51.0 Years n=4 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	5 Participants n=7 Participants	17 Participants n=5 Participants	23 Participants n=4 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	5 Participants n=7 Participants	27 Participants n=5 Participants	37 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	5 Participants n=5 Participants	8 Participants n=7 Participants	41 Participants n=5 Participants	54 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	5 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants	4 Participants n=4 Participants
Race (NIH/OMB) White	6 Participants n=5 Participants	7 Participants n=7 Participants	36 Participants n=5 Participants	49 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants	6 Participants n=4 Participants
Region of Enrollment United States	6 participants n=5 Participants	10 participants n=7 Participants	44 participants n=5 Participants	60 participants n=4 Participants

PRIMARY outcome

Timeframe: First 2 treatment cycles (2 months)

Dose-limiting-toxicities within the first 2 cycles of treatment with nab-sirolimus at various doses and schedule in combination with mFOLFOX6 and bevacizumab

Outcome measures

Outcome measures
Measure	Cohort 1: Nab-Sirolimus 30 mg/m2 qw3/4 n=6 Participants Dose / Schedule Cohort 1: nab-Sirolimus: 30 mg/m2 weekly on Days 1, 8, and 15 (28-day cycle) by IV Modified FOLFOX6 regimen: oxaliplatin 85 mg/m2 IV with LV 400 mg/m2 IV over 2 hours plus FU 400 mg/m2 IV bolus and 2,400 mg/m2 continuous infusion over 46 hours every 2 weeks Bevacizumab: 5 mg/kg IV every 2 weeks	Cohort 2: Nab-Sirolimus 20 mg/m2 qw3/4 n=10 Participants Dose / Schedule Cohort 2: nab-Sirolimus: 20 mg/m2 weekly on Days 1, 8, and 15 (28-day cycle) by IV Modified FOLFOX6 regimen: oxaliplatin 85 mg/m2 IV with LV 400 mg/m2 IV over 2 hours plus FU 400 mg/m2 IV bolus and 2,400 mg/m2 continuous infusion over 46 hours every 2 weeks Bevacizumab: 5 mg/kg IV every 2 weeks	Cohort 3: Nab-Sirolimus 20 mg/m2 qw2/4 n=44 Participants Dose / Schedule Cohort 3 (Recommended Phase 2 Dose, RP2D): nab-Sirolimus: 20 mg/m2 every 2 weeks (28-day cycle) by IV Modified FOLFOX6 regimen: oxaliplatin 85 mg/m2 IV with LV 400 mg/m2 IV over 2 hours plus FU 400 mg/m2 IV bolus and 2,400 mg/m2 continuous infusion over 46 hours every 2 weeks Bevacizumab: 5 mg/kg IV every 2 weeks	All Patients n=60 Participants The safety analysis set includes all treated patients
Dose-limiting-toxicities (DLTs) (Phase 1)	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: 6 months

Population: The Efficacy Analysis Set includes all patients at baseline who received ≥2 doses of nab-sirolimus and had ≥1 scan. Based on the statistical design of this Phase 1/2 study, the efficacy endpoints are analyzed together for All Efficacy Evaluable patients (n=56) and at the RP2D (n=41). The data for all efficacy evaluable patients was also prospectively evaluated based on PTEN status for those with available IHC results (positive or negative, n=39 and n=12, respectively).

The PFS rate at 6 months was estimated using the Kaplan-Meier method for a) all efficacy evaluable patients, b) patients receiving treatment at the RP2D, and c) based on PTEN status (positive or negative). Progression-free survival was defined as the time from the first day of study drug administration to disease progression or death due to any cause. Response evaluation was performed per RECIST v1.1, with the criteria for progression is at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study.

Outcome measures

Outcome measures
Measure	Cohort 1: Nab-Sirolimus 30 mg/m2 qw3/4 n=56 Participants Dose / Schedule Cohort 1: nab-Sirolimus: 30 mg/m2 weekly on Days 1, 8, and 15 (28-day cycle) by IV Modified FOLFOX6 regimen: oxaliplatin 85 mg/m2 IV with LV 400 mg/m2 IV over 2 hours plus FU 400 mg/m2 IV bolus and 2,400 mg/m2 continuous infusion over 46 hours every 2 weeks Bevacizumab: 5 mg/kg IV every 2 weeks	Cohort 2: Nab-Sirolimus 20 mg/m2 qw3/4 n=41 Participants Dose / Schedule Cohort 2: nab-Sirolimus: 20 mg/m2 weekly on Days 1, 8, and 15 (28-day cycle) by IV Modified FOLFOX6 regimen: oxaliplatin 85 mg/m2 IV with LV 400 mg/m2 IV over 2 hours plus FU 400 mg/m2 IV bolus and 2,400 mg/m2 continuous infusion over 46 hours every 2 weeks Bevacizumab: 5 mg/kg IV every 2 weeks	Cohort 3: Nab-Sirolimus 20 mg/m2 qw2/4 n=39 Participants Dose / Schedule Cohort 3 (Recommended Phase 2 Dose, RP2D): nab-Sirolimus: 20 mg/m2 every 2 weeks (28-day cycle) by IV Modified FOLFOX6 regimen: oxaliplatin 85 mg/m2 IV with LV 400 mg/m2 IV over 2 hours plus FU 400 mg/m2 IV bolus and 2,400 mg/m2 continuous infusion over 46 hours every 2 weeks Bevacizumab: 5 mg/kg IV every 2 weeks	All Patients n=12 Participants The safety analysis set includes all treated patients
Progression-free Survival at 6 Months (Phase 2) for All Patients, at the RP2D, as Well as Based on PTEN Status (Positive and Negative)	77.3 percentage of patients Interval 63.5 to 86.5	76.3 percentage of patients Interval 59.2 to 86.9	78.2 percentage of patients Interval 61.0 to 88.5	82.5 percentage of patients Interval 46.1 to 95.3

SECONDARY outcome

Timeframe: Through study completion (up to 50 months)

Disease control rate is defined as patients who achieved complete response, partial response, or stable disease and was summarized for a) all efficacy evaluable patients, b) patients receiving treatment at the RP2D, and c) based on PTEN status (positive or negative). Complete response and partial response required confirmation of response at the subsequent tumor assessment. Stable disease required a confirmatory assessment at a minimum interval of 8 weeks

Outcome measures

Outcome measures
Measure	Cohort 1: Nab-Sirolimus 30 mg/m2 qw3/4 n=56 Participants Dose / Schedule Cohort 1: nab-Sirolimus: 30 mg/m2 weekly on Days 1, 8, and 15 (28-day cycle) by IV Modified FOLFOX6 regimen: oxaliplatin 85 mg/m2 IV with LV 400 mg/m2 IV over 2 hours plus FU 400 mg/m2 IV bolus and 2,400 mg/m2 continuous infusion over 46 hours every 2 weeks Bevacizumab: 5 mg/kg IV every 2 weeks	Cohort 2: Nab-Sirolimus 20 mg/m2 qw3/4 n=41 Participants Dose / Schedule Cohort 2: nab-Sirolimus: 20 mg/m2 weekly on Days 1, 8, and 15 (28-day cycle) by IV Modified FOLFOX6 regimen: oxaliplatin 85 mg/m2 IV with LV 400 mg/m2 IV over 2 hours plus FU 400 mg/m2 IV bolus and 2,400 mg/m2 continuous infusion over 46 hours every 2 weeks Bevacizumab: 5 mg/kg IV every 2 weeks	Cohort 3: Nab-Sirolimus 20 mg/m2 qw2/4 n=39 Participants Dose / Schedule Cohort 3 (Recommended Phase 2 Dose, RP2D): nab-Sirolimus: 20 mg/m2 every 2 weeks (28-day cycle) by IV Modified FOLFOX6 regimen: oxaliplatin 85 mg/m2 IV with LV 400 mg/m2 IV over 2 hours plus FU 400 mg/m2 IV bolus and 2,400 mg/m2 continuous infusion over 46 hours every 2 weeks Bevacizumab: 5 mg/kg IV every 2 weeks	All Patients n=12 Participants The safety analysis set includes all treated patients
Disease Control Rate (DCR) (Phase 2) for All Patients, at the RP2D, as Well as Based on PTEN Status (Positive and Negative)	78.6 percentage of efficacy analysis patients Interval 65.6 to 88.4	75.6 percentage of efficacy analysis patients Interval 59.7 to 87.6	79.5 percentage of efficacy analysis patients Interval 63.5 to 90.7	83.3 percentage of efficacy analysis patients Interval 51.6 to 97.9

SECONDARY outcome

Timeframe: Through study completion (up to 50 months)

The median PFS was estimated using the Kaplan-Meier method for a) all efficacy evaluable patients, b) patients receiving treatment at the RP2D, and c) based on PTEN status (positive or negative). Progression-free survival was defined as the time from the first day of study drug administration to disease progression or death due to any cause. Response evaluation was performed per RECIST v1.1, with the criteria for progression is at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study.

Outcome measures

Outcome measures
Measure	Cohort 1: Nab-Sirolimus 30 mg/m2 qw3/4 n=56 Participants Dose / Schedule Cohort 1: nab-Sirolimus: 30 mg/m2 weekly on Days 1, 8, and 15 (28-day cycle) by IV Modified FOLFOX6 regimen: oxaliplatin 85 mg/m2 IV with LV 400 mg/m2 IV over 2 hours plus FU 400 mg/m2 IV bolus and 2,400 mg/m2 continuous infusion over 46 hours every 2 weeks Bevacizumab: 5 mg/kg IV every 2 weeks	Cohort 2: Nab-Sirolimus 20 mg/m2 qw3/4 n=41 Participants Dose / Schedule Cohort 2: nab-Sirolimus: 20 mg/m2 weekly on Days 1, 8, and 15 (28-day cycle) by IV Modified FOLFOX6 regimen: oxaliplatin 85 mg/m2 IV with LV 400 mg/m2 IV over 2 hours plus FU 400 mg/m2 IV bolus and 2,400 mg/m2 continuous infusion over 46 hours every 2 weeks Bevacizumab: 5 mg/kg IV every 2 weeks	Cohort 3: Nab-Sirolimus 20 mg/m2 qw2/4 n=39 Participants Dose / Schedule Cohort 3 (Recommended Phase 2 Dose, RP2D): nab-Sirolimus: 20 mg/m2 every 2 weeks (28-day cycle) by IV Modified FOLFOX6 regimen: oxaliplatin 85 mg/m2 IV with LV 400 mg/m2 IV over 2 hours plus FU 400 mg/m2 IV bolus and 2,400 mg/m2 continuous infusion over 46 hours every 2 weeks Bevacizumab: 5 mg/kg IV every 2 weeks	All Patients n=12 Participants The safety analysis set includes all treated patients
Median Progression-free Survival (Phase 2) for All Patients, at the RP2D, as Well as Based on PTEN Status (Positive and Negative)	10.9 Month Interval 8.5 to 15.7	10.9 Month Interval 7.3 to 14.5	13.1 Month Interval 9.2 to 19.8	10.4 Month Interval 5.5 to 22.4

SECONDARY outcome

Timeframe: Through study completion (up to 50 months)

The ORR was the proportion of patients who achieved a confirmed partial response or complete response per RECIST v1.1, and summarized for a) all efficacy evaluable patients, b) patients receiving treatment at the RP2D, and c) based on PTEN status (positive or negative). The ORR was reported along with exact 95% confidence intervals computed by the Clopper-Pearson method. Per RECIST v1.1, at each timepoint, objective tumor response for target lesions were assessed as such: Complete Response, disappearance of all target lesions, and pathological lymph nodes must have a reduction \<10 mm; Partial Response, ≥30% decrease in the sum of the longest diameter of target lesions.

Outcome measures

Outcome measures
Measure	Cohort 1: Nab-Sirolimus 30 mg/m2 qw3/4 n=56 Participants Dose / Schedule Cohort 1: nab-Sirolimus: 30 mg/m2 weekly on Days 1, 8, and 15 (28-day cycle) by IV Modified FOLFOX6 regimen: oxaliplatin 85 mg/m2 IV with LV 400 mg/m2 IV over 2 hours plus FU 400 mg/m2 IV bolus and 2,400 mg/m2 continuous infusion over 46 hours every 2 weeks Bevacizumab: 5 mg/kg IV every 2 weeks	Cohort 2: Nab-Sirolimus 20 mg/m2 qw3/4 n=41 Participants Dose / Schedule Cohort 2: nab-Sirolimus: 20 mg/m2 weekly on Days 1, 8, and 15 (28-day cycle) by IV Modified FOLFOX6 regimen: oxaliplatin 85 mg/m2 IV with LV 400 mg/m2 IV over 2 hours plus FU 400 mg/m2 IV bolus and 2,400 mg/m2 continuous infusion over 46 hours every 2 weeks Bevacizumab: 5 mg/kg IV every 2 weeks	Cohort 3: Nab-Sirolimus 20 mg/m2 qw2/4 n=39 Participants Dose / Schedule Cohort 3 (Recommended Phase 2 Dose, RP2D): nab-Sirolimus: 20 mg/m2 every 2 weeks (28-day cycle) by IV Modified FOLFOX6 regimen: oxaliplatin 85 mg/m2 IV with LV 400 mg/m2 IV over 2 hours plus FU 400 mg/m2 IV bolus and 2,400 mg/m2 continuous infusion over 46 hours every 2 weeks Bevacizumab: 5 mg/kg IV every 2 weeks	All Patients n=12 Participants The safety analysis set includes all treated patients
Overall Response Rate (Phase 2) for All Patients, at the RP2D, as Well as Based on PTEN Status (Positive and Negative)	39.3 percentage of efficacy analysis patients Interval 26.5 to 53.2	36.6 percentage of efficacy analysis patients Interval 22.1 to 53.1	43.6 percentage of efficacy analysis patients Interval 27.8 to 60.4	41.7 percentage of efficacy analysis patients Interval 15.2 to 72.3

Adverse Events

Cohort 1: Nab-Sirolimus 30 mg/m2 qw3/4

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Cohort 2 Nab-Sirolimus 20 mg/m2 qw3/4

Serious events: 2 serious events

Other events: 9 other events

Deaths: 1 deaths

Cohort 3: Nab-Sirolimus 20 mg/m2 qw2/4

Serious events: 5 serious events

Other events: 44 other events

Deaths: 3 deaths

Total

Serious events: 7 serious events

Other events: 59 other events

Deaths: 4 deaths

Serious adverse events

Serious adverse events
Measure	Cohort 1: Nab-Sirolimus 30 mg/m2 qw3/4 n=6 participants at risk Dose / Schedule Cohort 1: nab-Sirolimus: 30 mg/m2 weekly on Days 1, 8, and 15 (28-day cycle) by IV Modified FOLFOX6 regimen: oxaliplatin 85 mg/m2 IV with LV 400 mg/m2 IV over 2 hours plus FU 400 mg/m2 IV bolus and 2,400 mg/m2 continuous infusion over 46 hours every 2 weeks Bevacizumab: 5 mg/kg IV every 2 weeks	Cohort 2 Nab-Sirolimus 20 mg/m2 qw3/4 n=10 participants at risk Dose / Schedule Cohort 2: nab-Sirolimus: 20 mg/m2 weekly on Days 1, 8, and 15 (28-day cycle) by IV Modified FOLFOX6 regimen: oxaliplatin 85 mg/m2 IV with LV 400 mg/m2 IV over 2 hours plus FU 400 mg/m2 IV bolus and 2,400 mg/m2 continuous infusion over 46 hours every 2 weeks Bevacizumab: 5 mg/kg IV every 2 weeks	Cohort 3: Nab-Sirolimus 20 mg/m2 qw2/4 n=44 participants at risk Dose / Schedule Cohort 3 (Recommended Phase 2 Dose, RP2D): nab-Sirolimus: 20 mg/m2 every 2 weeks (28-day cycle) by IV Modified FOLFOX6 regimen: oxaliplatin 85 mg/m2 IV with LV 400 mg/m2 IV over 2 hours plus FU 400 mg/m2 IV bolus and 2,400 mg/m2 continuous infusion over 46 hours every 2 weeks Bevacizumab: 5 mg/kg IV every 2 weeks	Total n=60 participants at risk The safety analysis set includes all treated patients
Gastrointestinal disorders Rectal perforation	0.00% 0/6 • Safety and tolerability was monitored through continuous reporting of treatment-emergent and treatment-related AEs, Serious AEs, laboratory abnormalities, and incidence of patients experiencing dose modifications, dose delay/dose not given, and/or premature discontinuation of study drugs due to an AE. All AEs will be recorded by the investigator from the time the patient signs informed consent until 28 days after the last dose of study drugs (up to 50 months)	0.00% 0/10 • Safety and tolerability was monitored through continuous reporting of treatment-emergent and treatment-related AEs, Serious AEs, laboratory abnormalities, and incidence of patients experiencing dose modifications, dose delay/dose not given, and/or premature discontinuation of study drugs due to an AE. All AEs will be recorded by the investigator from the time the patient signs informed consent until 28 days after the last dose of study drugs (up to 50 months)	2.3% 1/44 • Safety and tolerability was monitored through continuous reporting of treatment-emergent and treatment-related AEs, Serious AEs, laboratory abnormalities, and incidence of patients experiencing dose modifications, dose delay/dose not given, and/or premature discontinuation of study drugs due to an AE. All AEs will be recorded by the investigator from the time the patient signs informed consent until 28 days after the last dose of study drugs (up to 50 months)	1.7% 1/60 • Safety and tolerability was monitored through continuous reporting of treatment-emergent and treatment-related AEs, Serious AEs, laboratory abnormalities, and incidence of patients experiencing dose modifications, dose delay/dose not given, and/or premature discontinuation of study drugs due to an AE. All AEs will be recorded by the investigator from the time the patient signs informed consent until 28 days after the last dose of study drugs (up to 50 months)
Gastrointestinal disorders Stomatitis	0.00% 0/6 • Safety and tolerability was monitored through continuous reporting of treatment-emergent and treatment-related AEs, Serious AEs, laboratory abnormalities, and incidence of patients experiencing dose modifications, dose delay/dose not given, and/or premature discontinuation of study drugs due to an AE. All AEs will be recorded by the investigator from the time the patient signs informed consent until 28 days after the last dose of study drugs (up to 50 months)	0.00% 0/10 • Safety and tolerability was monitored through continuous reporting of treatment-emergent and treatment-related AEs, Serious AEs, laboratory abnormalities, and incidence of patients experiencing dose modifications, dose delay/dose not given, and/or premature discontinuation of study drugs due to an AE. All AEs will be recorded by the investigator from the time the patient signs informed consent until 28 days after the last dose of study drugs (up to 50 months)	2.3% 1/44 • Safety and tolerability was monitored through continuous reporting of treatment-emergent and treatment-related AEs, Serious AEs, laboratory abnormalities, and incidence of patients experiencing dose modifications, dose delay/dose not given, and/or premature discontinuation of study drugs due to an AE. All AEs will be recorded by the investigator from the time the patient signs informed consent until 28 days after the last dose of study drugs (up to 50 months)	1.7% 1/60 • Safety and tolerability was monitored through continuous reporting of treatment-emergent and treatment-related AEs, Serious AEs, laboratory abnormalities, and incidence of patients experiencing dose modifications, dose delay/dose not given, and/or premature discontinuation of study drugs due to an AE. All AEs will be recorded by the investigator from the time the patient signs informed consent until 28 days after the last dose of study drugs (up to 50 months)
Metabolism and nutrition disorders Decreased appetite	0.00% 0/6 • Safety and tolerability was monitored through continuous reporting of treatment-emergent and treatment-related AEs, Serious AEs, laboratory abnormalities, and incidence of patients experiencing dose modifications, dose delay/dose not given, and/or premature discontinuation of study drugs due to an AE. All AEs will be recorded by the investigator from the time the patient signs informed consent until 28 days after the last dose of study drugs (up to 50 months)	0.00% 0/10 • Safety and tolerability was monitored through continuous reporting of treatment-emergent and treatment-related AEs, Serious AEs, laboratory abnormalities, and incidence of patients experiencing dose modifications, dose delay/dose not given, and/or premature discontinuation of study drugs due to an AE. All AEs will be recorded by the investigator from the time the patient signs informed consent until 28 days after the last dose of study drugs (up to 50 months)	4.5% 2/44 • Safety and tolerability was monitored through continuous reporting of treatment-emergent and treatment-related AEs, Serious AEs, laboratory abnormalities, and incidence of patients experiencing dose modifications, dose delay/dose not given, and/or premature discontinuation of study drugs due to an AE. All AEs will be recorded by the investigator from the time the patient signs informed consent until 28 days after the last dose of study drugs (up to 50 months)	3.3% 2/60 • Safety and tolerability was monitored through continuous reporting of treatment-emergent and treatment-related AEs, Serious AEs, laboratory abnormalities, and incidence of patients experiencing dose modifications, dose delay/dose not given, and/or premature discontinuation of study drugs due to an AE. All AEs will be recorded by the investigator from the time the patient signs informed consent until 28 days after the last dose of study drugs (up to 50 months)
Infections and infestations Pneumonia	0.00% 0/6 • Safety and tolerability was monitored through continuous reporting of treatment-emergent and treatment-related AEs, Serious AEs, laboratory abnormalities, and incidence of patients experiencing dose modifications, dose delay/dose not given, and/or premature discontinuation of study drugs due to an AE. All AEs will be recorded by the investigator from the time the patient signs informed consent until 28 days after the last dose of study drugs (up to 50 months)	10.0% 1/10 • Safety and tolerability was monitored through continuous reporting of treatment-emergent and treatment-related AEs, Serious AEs, laboratory abnormalities, and incidence of patients experiencing dose modifications, dose delay/dose not given, and/or premature discontinuation of study drugs due to an AE. All AEs will be recorded by the investigator from the time the patient signs informed consent until 28 days after the last dose of study drugs (up to 50 months)	0.00% 0/44 • Safety and tolerability was monitored through continuous reporting of treatment-emergent and treatment-related AEs, Serious AEs, laboratory abnormalities, and incidence of patients experiencing dose modifications, dose delay/dose not given, and/or premature discontinuation of study drugs due to an AE. All AEs will be recorded by the investigator from the time the patient signs informed consent until 28 days after the last dose of study drugs (up to 50 months)	1.7% 1/60 • Safety and tolerability was monitored through continuous reporting of treatment-emergent and treatment-related AEs, Serious AEs, laboratory abnormalities, and incidence of patients experiencing dose modifications, dose delay/dose not given, and/or premature discontinuation of study drugs due to an AE. All AEs will be recorded by the investigator from the time the patient signs informed consent until 28 days after the last dose of study drugs (up to 50 months)
Gastrointestinal disorders Colitis	0.00% 0/6 • Safety and tolerability was monitored through continuous reporting of treatment-emergent and treatment-related AEs, Serious AEs, laboratory abnormalities, and incidence of patients experiencing dose modifications, dose delay/dose not given, and/or premature discontinuation of study drugs due to an AE. All AEs will be recorded by the investigator from the time the patient signs informed consent until 28 days after the last dose of study drugs (up to 50 months)	10.0% 1/10 • Safety and tolerability was monitored through continuous reporting of treatment-emergent and treatment-related AEs, Serious AEs, laboratory abnormalities, and incidence of patients experiencing dose modifications, dose delay/dose not given, and/or premature discontinuation of study drugs due to an AE. All AEs will be recorded by the investigator from the time the patient signs informed consent until 28 days after the last dose of study drugs (up to 50 months)	0.00% 0/44 • Safety and tolerability was monitored through continuous reporting of treatment-emergent and treatment-related AEs, Serious AEs, laboratory abnormalities, and incidence of patients experiencing dose modifications, dose delay/dose not given, and/or premature discontinuation of study drugs due to an AE. All AEs will be recorded by the investigator from the time the patient signs informed consent until 28 days after the last dose of study drugs (up to 50 months)	1.7% 1/60 • Safety and tolerability was monitored through continuous reporting of treatment-emergent and treatment-related AEs, Serious AEs, laboratory abnormalities, and incidence of patients experiencing dose modifications, dose delay/dose not given, and/or premature discontinuation of study drugs due to an AE. All AEs will be recorded by the investigator from the time the patient signs informed consent until 28 days after the last dose of study drugs (up to 50 months)
Gastrointestinal disorders Enterocolitis infectious	0.00% 0/6 • Safety and tolerability was monitored through continuous reporting of treatment-emergent and treatment-related AEs, Serious AEs, laboratory abnormalities, and incidence of patients experiencing dose modifications, dose delay/dose not given, and/or premature discontinuation of study drugs due to an AE. All AEs will be recorded by the investigator from the time the patient signs informed consent until 28 days after the last dose of study drugs (up to 50 months)	0.00% 0/10 • Safety and tolerability was monitored through continuous reporting of treatment-emergent and treatment-related AEs, Serious AEs, laboratory abnormalities, and incidence of patients experiencing dose modifications, dose delay/dose not given, and/or premature discontinuation of study drugs due to an AE. All AEs will be recorded by the investigator from the time the patient signs informed consent until 28 days after the last dose of study drugs (up to 50 months)	2.3% 1/44 • Safety and tolerability was monitored through continuous reporting of treatment-emergent and treatment-related AEs, Serious AEs, laboratory abnormalities, and incidence of patients experiencing dose modifications, dose delay/dose not given, and/or premature discontinuation of study drugs due to an AE. All AEs will be recorded by the investigator from the time the patient signs informed consent until 28 days after the last dose of study drugs (up to 50 months)	1.7% 1/60 • Safety and tolerability was monitored through continuous reporting of treatment-emergent and treatment-related AEs, Serious AEs, laboratory abnormalities, and incidence of patients experiencing dose modifications, dose delay/dose not given, and/or premature discontinuation of study drugs due to an AE. All AEs will be recorded by the investigator from the time the patient signs informed consent until 28 days after the last dose of study drugs (up to 50 months)

Other adverse events

Additional Information

Aadi Medical Information

Aadi Bioscience, Inc.

Phone: 1-888-246-2234

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place