NCT02419417: BET

Study of BMS-986158 in Subjects With Select Advanced Cancers

Completed Phase 1, PHASE2 Results posted Last updated 16 June 2022

What this trial tests

Phase 1, PHASE2 trial testing BMS-986158 in Advanced Tumors in 83 participants. Completed in 17 March 2021.

Timeline

19 June 2015

Primary endpoint
17 March 2021

17 March 2021

Quick facts

Lead sponsor	Bristol-Myers Squibb
Phase	Phase 1, PHASE2
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	83
Start date	19 June 2015
Primary completion	17 March 2021
Estimated completion	17 March 2021
Sites	13 locations across France, Canada, Australia, United States, Spain

Drugs / interventions tested

• BMS-986158 — full drug profile →
• Nivolumab (nivolumab) — full drug profile →

Conditions studied

• Advanced Tumors — all drugs for Advanced Tumors →

Sponsor

Bristol-Myers Squibb — full company profile →

Who can join

12 and older, any sex, with Advanced Tumors. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants Experiencing Adverse Events Primary · From first dose to 30 days following last dose (up to approximately 29 months)

Number of participants experiencing different types of events, including Adverse Events (AEs), Serious Adverse Events (SAEs), AEs leading to discontinuation and deaths. Events are classified based on the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.

Adverse Events (AEs)

Group	Value	95% CI
Part 1 Schedule A - BMS-986158 0.75 mg	5
Part 1 Schedule A - BMS-986158 1.25 mg	4
Part 1 Schedule A - BMS-986158 2 mg	13
Part 1 Schedule A - BMS-986158 3 mg	10
Part 1 Schedule A - BMS-986158 4.5 mg	13
Part 1 Schedule B - BMS-986158 2 mg	4
Part 1 Schedule B - BMS-986158 3 mg	4
Part 1 Schedule C - BMS-986158 2 mg	6
Part 1 Schedule C - BMS-986158 3 mg	13
Part 1 Schedule C - BMS-986158 4.5 mg	9
Part 2 Schedule A	1

Serious Adverse Events (SAEs)

Group	Value	95% CI
Part 1 Schedule A - BMS-986158 0.75 mg	3
Part 1 Schedule A - BMS-986158 1.25 mg	3
Part 1 Schedule A - BMS-986158 2 mg	7
Part 1 Schedule A - BMS-986158 3 mg	7
Part 1 Schedule A - BMS-986158 4.5 mg	9
Part 1 Schedule B - BMS-986158 2 mg	2
Part 1 Schedule B - BMS-986158 3 mg	2
Part 1 Schedule C - BMS-986158 2 mg	4
Part 1 Schedule C - BMS-986158 3 mg	5
Part 1 Schedule C - BMS-986158 4.5 mg	3
Part 2 Schedule A	0

AEs leading to discontinuation

Group	Value	95% CI
Part 1 Schedule A - BMS-986158 0.75 mg	0
Part 1 Schedule A - BMS-986158 1.25 mg	0
Part 1 Schedule A - BMS-986158 2 mg	0
Part 1 Schedule A - BMS-986158 3 mg	1
Part 1 Schedule A - BMS-986158 4.5 mg	3
Part 1 Schedule B - BMS-986158 2 mg	1
Part 1 Schedule B - BMS-986158 3 mg	0
Part 1 Schedule C - BMS-986158 2 mg	1
Part 1 Schedule C - BMS-986158 3 mg	0
Part 1 Schedule C - BMS-986158 4.5 mg	0
Part 2 Schedule A	0

Deaths

Group	Value	95% CI
Part 1 Schedule A - BMS-986158 0.75 mg	0
Part 1 Schedule A - BMS-986158 1.25 mg	1
Part 1 Schedule A - BMS-986158 2 mg	2
Part 1 Schedule A - BMS-986158 3 mg	4
Part 1 Schedule A - BMS-986158 4.5 mg	3
Part 1 Schedule B - BMS-986158 2 mg	0
Part 1 Schedule B - BMS-986158 3 mg	0
Part 1 Schedule C - BMS-986158 2 mg	1
Part 1 Schedule C - BMS-986158 3 mg	2
Part 1 Schedule C - BMS-986158 4.5 mg	0
Part 2 Schedule A	0

Number of Participants With Abnormal Hepatic Test Values Primary · From first dose to 30 days following last dose (up to approximately 29 months)

Number of participants experiencing abnormal hepatic function, as measured by different parameters. ALT = Alanine aminotransferase AST = Aspartate aminotransferase ULN = Upper Limit of Normal

ALT OR AST > 3XULN

Group	Value	95% CI
Part 1 Schedule A - BMS-986158 0.75 mg	2
Part 1 Schedule A - BMS-986158 1.25 mg	1
Part 1 Schedule A - BMS-986158 2 mg	2
Part 1 Schedule A - BMS-986158 3 mg	2
Part 1 Schedule A - BMS-986158 4.5 mg	2
Part 1 Schedule B - BMS-986158 2 mg	0
Part 1 Schedule B - BMS-986158 3 mg	1
Part 1 Schedule C - BMS-986158 2 mg	0
Part 1 Schedule C - BMS-986158 3 mg	2
Part 1 Schedule C - BMS-986158 4.5 mg	2
Part 2 Schedule A	0

ALT OR AST > 5XULN

Group	Value	95% CI
Part 1 Schedule A - BMS-986158 0.75 mg	1
Part 1 Schedule A - BMS-986158 1.25 mg	0
Part 1 Schedule A - BMS-986158 2 mg	2
Part 1 Schedule A - BMS-986158 3 mg	1
Part 1 Schedule A - BMS-986158 4.5 mg	2
Part 1 Schedule B - BMS-986158 2 mg	0
Part 1 Schedule B - BMS-986158 3 mg	0
Part 1 Schedule C - BMS-986158 2 mg	0
Part 1 Schedule C - BMS-986158 3 mg	2
Part 1 Schedule C - BMS-986158 4.5 mg	1
Part 2 Schedule A	0

ALT OR AST > 10XULN

Group	Value	95% CI
Part 1 Schedule A - BMS-986158 0.75 mg	0
Part 1 Schedule A - BMS-986158 1.25 mg	0
Part 1 Schedule A - BMS-986158 2 mg	1
Part 1 Schedule A - BMS-986158 3 mg	1
Part 1 Schedule A - BMS-986158 4.5 mg	0
Part 1 Schedule B - BMS-986158 2 mg	0
Part 1 Schedule B - BMS-986158 3 mg	0
Part 1 Schedule C - BMS-986158 2 mg	0
Part 1 Schedule C - BMS-986158 3 mg	0
Part 1 Schedule C - BMS-986158 4.5 mg	0
Part 2 Schedule A	0

ALT OR AST > 20XULN

Group	Value	95% CI
Part 1 Schedule A - BMS-986158 0.75 mg	0
Part 1 Schedule A - BMS-986158 1.25 mg	0
Part 1 Schedule A - BMS-986158 2 mg	0
Part 1 Schedule A - BMS-986158 3 mg	0
Part 1 Schedule A - BMS-986158 4.5 mg	0
Part 1 Schedule B - BMS-986158 2 mg	0
Part 1 Schedule B - BMS-986158 3 mg	0
Part 1 Schedule C - BMS-986158 2 mg	0
Part 1 Schedule C - BMS-986158 3 mg	0
Part 1 Schedule C - BMS-986158 4.5 mg	0
Part 2 Schedule A	0

TOTAL BILIRUBIN > 2XULN

Group	Value	95% CI
Part 1 Schedule A - BMS-986158 0.75 mg	1
Part 1 Schedule A - BMS-986158 1.25 mg	0
Part 1 Schedule A - BMS-986158 2 mg	0
Part 1 Schedule A - BMS-986158 3 mg	1
Part 1 Schedule A - BMS-986158 4.5 mg	4
Part 1 Schedule B - BMS-986158 2 mg	0
Part 1 Schedule B - BMS-986158 3 mg	1
Part 1 Schedule C - BMS-986158 2 mg	0
Part 1 Schedule C - BMS-986158 3 mg	0
Part 1 Schedule C - BMS-986158 4.5 mg	1
Part 2 Schedule A	1

CONCURRENT ALT OR AST > 3XULN AND BILIRUB > 2XULN WITHIN 1 DAY

Group	Value	95% CI
Part 1 Schedule A - BMS-986158 0.75 mg	1
Part 1 Schedule A - BMS-986158 1.25 mg	0
Part 1 Schedule A - BMS-986158 2 mg	0
Part 1 Schedule A - BMS-986158 3 mg	1
Part 1 Schedule A - BMS-986158 4.5 mg	0
Part 1 Schedule B - BMS-986158 2 mg	0
Part 1 Schedule B - BMS-986158 3 mg	0
Part 1 Schedule C - BMS-986158 2 mg	0
Part 1 Schedule C - BMS-986158 3 mg	0
Part 1 Schedule C - BMS-986158 4.5 mg	1
Part 2 Schedule A	0

CONCURRENT ALT OR AST > 3XULN AND BILIRUB > 2XULN WITHIN 30 DAYS

Group	Value	95% CI
Part 1 Schedule A - BMS-986158 0.75 mg	1
Part 1 Schedule A - BMS-986158 1.25 mg	0
Part 1 Schedule A - BMS-986158 2 mg	0
Part 1 Schedule A - BMS-986158 3 mg	1
Part 1 Schedule A - BMS-986158 4.5 mg	0
Part 1 Schedule B - BMS-986158 2 mg	0
Part 1 Schedule B - BMS-986158 3 mg	1
Part 1 Schedule C - BMS-986158 2 mg	0
Part 1 Schedule C - BMS-986158 3 mg	0
Part 1 Schedule C - BMS-986158 4.5 mg	1
Part 2 Schedule A	0

Best Overall Response (BOR) Secondary · From first dose to date of first documented progression or subsequent therapy (up to approximately 28 months)

BOR, as assessed by the investigator, is defined as the best response designation, recorded between the dates of first dose and the date of first objectively documented progression (per RECIST v1.1 for solid tumors, Lugano 2014 criteria for hematologic malignancies or PCWG3 for prostate cancer) or the date of subsequent therapy, whichever occurs first.

Complete Response

Group	Value	95% CI
Part 1 Schedule A - BMS-986158 0.75 mg	0
Part 1 Schedule A - BMS-986158 1.25 mg	0
Part 1 Schedule A - BMS-986158 2 mg	0
Part 1 Schedule A - BMS-986158 3 mg	0
Part 1 Schedule A - BMS-986158 4.5 mg	0
Part 1 Schedule B - BMS-986158 2 mg	0
Part 1 Schedule B - BMS-986158 3 mg	0
Part 1 Schedule C - BMS-986158 2 mg	0
Part 1 Schedule C - BMS-986158 3 mg	0
Part 1 Schedule C - BMS-986158 4.5 mg	0
Part 2 Schedule A	0

Partial Response

Group	Value	95% CI
Part 1 Schedule A - BMS-986158 0.75 mg	0
Part 1 Schedule A - BMS-986158 1.25 mg	0
Part 1 Schedule A - BMS-986158 2 mg	0
Part 1 Schedule A - BMS-986158 3 mg	0
Part 1 Schedule A - BMS-986158 4.5 mg	1
Part 1 Schedule B - BMS-986158 2 mg	0
Part 1 Schedule B - BMS-986158 3 mg	0
Part 1 Schedule C - BMS-986158 2 mg	0
Part 1 Schedule C - BMS-986158 3 mg	0
Part 1 Schedule C - BMS-986158 4.5 mg	0
Part 2 Schedule A	1

Stable Disease

Group	Value	95% CI
Part 1 Schedule A - BMS-986158 0.75 mg	1
Part 1 Schedule A - BMS-986158 1.25 mg	1
Part 1 Schedule A - BMS-986158 2 mg	2
Part 1 Schedule A - BMS-986158 3 mg	1
Part 1 Schedule A - BMS-986158 4.5 mg	7
Part 1 Schedule B - BMS-986158 2 mg	2
Part 1 Schedule B - BMS-986158 3 mg	1
Part 1 Schedule C - BMS-986158 2 mg	1
Part 1 Schedule C - BMS-986158 3 mg	4
Part 1 Schedule C - BMS-986158 4.5 mg	4
Part 2 Schedule A	0

Progressive Disease

Group	Value	95% CI
Part 1 Schedule A - BMS-986158 0.75 mg	4
Part 1 Schedule A - BMS-986158 1.25 mg	2
Part 1 Schedule A - BMS-986158 2 mg	8
Part 1 Schedule A - BMS-986158 3 mg	7
Part 1 Schedule A - BMS-986158 4.5 mg	3
Part 1 Schedule B - BMS-986158 2 mg	2
Part 1 Schedule B - BMS-986158 3 mg	2
Part 1 Schedule C - BMS-986158 2 mg	2
Part 1 Schedule C - BMS-986158 3 mg	9
Part 1 Schedule C - BMS-986158 4.5 mg	4
Part 2 Schedule A	0

Unable to determine

Group	Value	95% CI
Part 1 Schedule A - BMS-986158 0.75 mg	0
Part 1 Schedule A - BMS-986158 1.25 mg	1
Part 1 Schedule A - BMS-986158 2 mg	3
Part 1 Schedule A - BMS-986158 3 mg	2
Part 1 Schedule A - BMS-986158 4.5 mg	2
Part 1 Schedule B - BMS-986158 2 mg	0
Part 1 Schedule B - BMS-986158 3 mg	1
Part 1 Schedule C - BMS-986158 2 mg	3
Part 1 Schedule C - BMS-986158 3 mg	0
Part 1 Schedule C - BMS-986158 4.5 mg	2
Part 2 Schedule A	0

Objective Response Rate (ORR) Secondary · From first dose to date of first documented progression or subsequent therapy (up to approximately 28 months)

ORR is defined as the percentage of participants who achieved a best overall response of Complete Response (CR) or Partial Response (PR)

Group	Value	95% CI
Part 1 Schedule A - BMS-986158 0.75 mg	0	0.0 – 52.2
Part 1 Schedule A - BMS-986158 1.25 mg	0	0.0 – 60.2
Part 1 Schedule A - BMS-986158 2 mg	0	0.0 – 24.7
Part 1 Schedule A - BMS-986158 3 mg	0	0.0 – 30.8
Part 1 Schedule A - BMS-986158 4.5 mg	7.7	0.2 – 36.0
Part 1 Schedule B - BMS-986158 2 mg	0	0.0 – 60.2
Part 1 Schedule B - BMS-986158 3 mg	0	0.0 – 60.2
Part 1 Schedule C - BMS-986158 2 mg	0	0.0 – 45.9
Part 1 Schedule C - BMS-986158 3 mg	0	0.0 – 24.7
Part 1 Schedule C - BMS-986158 4.5 mg	0	0.0 – 30.8
Part 2 Schedule A	100.0	2.5 – 100.0

Duration of Response (DOR) Secondary · From date of first response to date of first objectively documented disease progression or death (up to approximately 42 weeks)

DOR is defined as the time between the date of first response and the date of the first objectively documented disease progression (as determined by RECIST v1.1 for solid tumors, Lugano 2014 criteria for hematologic malignancies, or PCWG3 (including PSA assessments) for prostate cancer \[CRPC or NEPC\]), or death due to any cause, whichever occurs first.

Group	Value	95% CI
Part 1 Schedule A - BMS-986158 4.5 mg	22.3	± NA
Part 2 Schedule A	42.4	± NA

Progression Free Survival (PFS) Secondary · From first dose to date of first objectively documented disease progression or death (up to approximately 28 months)

PFS is defined as the time from the first dose of study medication to the date of the first objective documentation of tumor progression or death due to any cause.

Group	Value	95% CI
Part 1 Schedule A - BMS-986158 0.75 mg	4.57	2.86 – 14.43
Part 1 Schedule A - BMS-986158 1.25 mg	9.71	6.57 – 25.43
Part 1 Schedule A - BMS-986158 2 mg	7.57	3.57 – 15.86
Part 1 Schedule A - BMS-986158 3 mg	7.43	2.57 – 8.43
Part 1 Schedule A - BMS-986158 4.5 mg	13.79	5.14 – 24.57
Part 1 Schedule B - BMS-986158 2 mg	24.29	6.29 – 120.14
Part 1 Schedule B - BMS-986158 3 mg	6.57	5.57 – 40.14
Part 1 Schedule C - BMS-986158 2 mg	8.29	5.29 – NA
Part 1 Schedule C - BMS-986158 3 mg	8.43	7.43 – 13.29
Part 1 Schedule C - BMS-986158 4.5 mg	9.14	4.57 – 18.14
Part 2 Schedule A	NA	NA – NA

Progression Free Survival Rate (PFSR) Secondary · From first dose to 12 weeks, to 24 weeks, and to 48 weeks after first dose

PFSR is defined as the percentage of participants who remain progression free and surviving at the specified timepoints (12 weeks, 24 weeks, and 48 weeks). Reported values are estimates derived from Kaplan-Meier analyses

12 weeks

Group	Value	95% CI
Part 1 Schedule A - BMS-986158 0.75 mg	20.0	0.8 – 58.2
Part 1 Schedule A - BMS-986158 1.25 mg	33.3	0.9 – 77.4
Part 1 Schedule A - BMS-986158 2 mg	27.3	6.5 – 53.9
Part 1 Schedule A - BMS-986158 3 mg	11.1	0.6 – 38.8
Part 1 Schedule A - BMS-986158 4.5 mg	50.0	18.4 – 75.3
Part 1 Schedule B - BMS-986158 2 mg	50.0	5.8 – 84.5
Part 1 Schedule B - BMS-986158 3 mg	33.3	0.9 – 77.4
Part 1 Schedule C - BMS-986158 2 mg	20.0	0.8 – 58.2
Part 1 Schedule C - BMS-986158 3 mg	27.5	6.6 – 54.2
Part 1 Schedule C - BMS-986158 4.5 mg	45.7	11.0 – 75.7
Part 2 Schedule A	100.0	100.0 – 100.0

24 weeks

Group	Value	95% CI
Part 1 Schedule A - BMS-986158 0.75 mg	0.0	NA – NA
Part 1 Schedule A - BMS-986158 1.25 mg	33.3	0.9 – 77.4
Part 1 Schedule A - BMS-986158 2 mg	9.1	0.5 – 33.3
Part 1 Schedule A - BMS-986158 3 mg	11.1	0.6 – 38.8
Part 1 Schedule A - BMS-986158 4.5 mg	30.0	7.1 – 57.8
Part 1 Schedule B - BMS-986158 2 mg	50.0	5.8 – 84.5
Part 1 Schedule B - BMS-986158 3 mg	33.3	0.9 – 77.4
Part 1 Schedule C - BMS-986158 2 mg	0.0	NA – NA
Part 1 Schedule C - BMS-986158 3 mg	18.3	2.9 – 44.4
Part 1 Schedule C - BMS-986158 4.5 mg	0.0	NA – NA
Part 2 Schedule A	100.0	100.0 – 100.0

48 weeks

Group	Value	95% CI
Part 1 Schedule A - BMS-986158 0.75 mg	0.0	NA – NA
Part 1 Schedule A - BMS-986158 1.25 mg	0.0	NA – NA
Part 1 Schedule A - BMS-986158 2 mg	0.0	NA – NA
Part 1 Schedule A - BMS-986158 3 mg	0.0	NA – NA
Part 1 Schedule A - BMS-986158 4.5 mg	0.0	NA – NA
Part 1 Schedule B - BMS-986158 2 mg	25.0	0.9 – 66.5
Part 1 Schedule B - BMS-986158 3 mg	0.0	NA – NA
Part 1 Schedule C - BMS-986158 2 mg	0.0	NA – NA
Part 1 Schedule C - BMS-986158 3 mg	9.2	0.5 – 33.5
Part 1 Schedule C - BMS-986158 4.5 mg	0.0	NA – NA
Part 2 Schedule A	100.0	100.0 – 100.0

Maximum Observed Plasma Concentration (Cmax) - Single Dose Administration Secondary · From drug administration in Cycle 1 Day 1 to 168 hours post drug administration

Values are reported separately for the parent BMS-986158 and its metabolite BMT-161485

Parent BMS-986158

Group	Value	95% CI
BMS-986158 0.75 mg	68.8	± 23
BMS-986158 1.25 mg	175	± 36
BMS-986158 2 mg	269	± 25
BMS-986158 3 mg	368	± 30
BMS-986158 4.5 mg	513	± 25

Metabolite BMT-161485

Group	Value	95% CI
BMS-986158 0.75 mg	5.00	± 30
BMS-986158 1.25 mg	10.0	± 29
BMS-986158 2 mg	18.2	± 36
BMS-986158 3 mg	21.6	± 47
BMS-986158 4.5 mg	35.6	± 41

Time of Maximum Observed Plasma Concentration (Tmax) - Single Dose Administration Secondary · From drug administration in Cycle 1 Day 1 to 168 hours post drug administration

Values are reported separately for the parent BMS-986158 and its metabolite BMT-161485

Parent BMS-986158

Group	Value	95% CI
BMS-986158 0.75 mg	4.00	2.00 – 4.02
BMS-986158 1.25 mg	1.00	1.00 – 2.00
BMS-986158 2 mg	1.04	0.500 – 4.03
BMS-986158 3 mg	1.02	0.500 – 6.15
BMS-986158 4.5 mg	2.02	1.00 – 4.03

Metabolite BMT-161485

Group	Value	95% CI
BMS-986158 0.75 mg	24.0	2.55 – 24.2
BMS-986158 1.25 mg	2.00	2.00 – 24.0
BMS-986158 2 mg	6.00	1.00 – 72.0
BMS-986158 3 mg	3.03	0.983 – 48.0
BMS-986158 4.5 mg	6.27	1.00 – 48.0

Area Under the Plasma Concentration-Time Curve in One Dosing Interval (AUC(0-24)) - Single Dose Administration Secondary · From drug administration in Cycle 1 Day 1 to 168 hours post drug administration

Values are reported separately for the parent BMS-986158 and its metabolite BMT-161485

Parent BMS-986158

Group	Value	95% CI
BMS-986158 0.75 mg	1027	± 16
BMS-986158 1.25 mg	2309	± 13
BMS-986158 2 mg	3533	± 25
BMS-986158 3 mg	4989	± 38
BMS-986158 4.5 mg	7039	± 34

Metabolite BMT-161485

Group	Value	95% CI
BMS-986158 0.75 mg	98.2	± 34
BMS-986158 1.25 mg	188	± 11
BMS-986158 2 mg	310	± 35
BMS-986158 3 mg	377	± 44
BMS-986158 4.5 mg	629	± 41

Apparent Terminal Phase Half-Life (T-HALF) - Single Dose Administration Secondary · From drug administration in Cycle 1 Day 1 to 168 hours post drug administration

Values are reported separately for the parent BMS-986158 and its metabolite BMT-161485

Parent BMS-986158

Group	Value	95% CI
BMS-986158 0.75 mg	33.7	± 1.41
BMS-986158 1.25 mg	48.7	± 6.66
BMS-986158 2 mg	54.3	± 19.87
BMS-986158 3 mg	42.7	± 19.56
BMS-986158 4.5 mg	43.8	± 15.75

Metabolite BMT-161485

Group	Value	95% CI
BMS-986158 0.75 mg	35.3	± NA
BMS-986158 1.25 mg	50.8	± 6.26
BMS-986158 2 mg	48.8	± 18.78
BMS-986158 3 mg	39.4	± 13.80
BMS-986158 4.5 mg	38.7	± 13.66

Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinite Time (AUC(INF)) - Single Dose Administration Secondary · From drug administration in Cycle 1 Day 1 to 168 hours post drug administration

Values are reported separately for the parent BMS-986158 and its metabolite BMT-161485

Parent BMS-986158

Group	Value	95% CI
BMS-986158 0.75 mg	2479	± 18
BMS-986158 1.25 mg	7013	± 17
BMS-986158 2 mg	9775	± 56
BMS-986158 3 mg	11677	± 44
BMS-986158 4.5 mg	18974	± 40

Metabolite BMT-161485

Group	Value	95% CI
BMS-986158 0.75 mg	409	± NA
BMS-986158 1.25 mg	892	± 13
BMS-986158 2 mg	944	± 73
BMS-986158 3 mg	1128	± 46
BMS-986158 4.5 mg	2231	± 67

Adverse events — posted to ClinicalTrials.gov

Time frame: All-cause mortality was assessed from date of first dose to study completion (up to approximately 68 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 29 months).. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Part 1 Schedule A - BMS-986158 0.75 mg

Serious: 3/5 (60%)

Deaths: 5/5

Part 1 Schedule A - BMS-986158 1.25 mg

Serious: 3/4 (75%)

Deaths: 3/4

Part 1 Schedule A - BMS-986158 2 mg

Serious: 7/13 (54%)

Deaths: 10/13

Part 1 Schedule A - BMS-986158 3 mg

Serious: 7/10 (70%)

Deaths: 8/10

Part 1 Schedule A - BMS-986158 4.5 mg

Serious: 9/13 (69%)

Deaths: 12/13

Part 1 Schedule B - BMS-986158 2 mg

Serious: 2/4 (50%)

Deaths: 3/4

Part 1 Schedule B - BMS-986158 3 mg

Serious: 2/4 (50%)

Deaths: 3/4

Part 1 Schedule C - BMS-986158 2 mg

Serious: 4/6 (67%)

Deaths: 4/6

Part 1 Schedule C - BMS-986158 3 mg

Serious: 5/13 (38%)

Deaths: 10/13

Part 1 Schedule C - BMS-986158 4.5 mg

Serious: 3/10 (30%)

Deaths: 7/10

Part 2 Schedule A

Serious: 0/1 (0%)

Deaths: 0/1

Serious adverse events (38 terms)

Reaction	System	Part 1 Schedule A - BMS-98…	Part 1 Schedule A - BMS-98…	Part 1 Schedule A - BMS-98…	Part 1 Schedule A - BMS-98…	Part 1 Schedule A - BMS-98…	Part 1 Schedule B - BMS-98…	Part 1 Schedule B - BMS-98…	Part 1 Schedule C - BMS-98…	Part 1 Schedule C - BMS-98…	Part 1 Schedule C - BMS-98…	Part 2 Schedule A
Malignant neoplasm progression	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—	—	—	—	—	—	—	—	—
Thrombocytopenia	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—	—	—	—
Intestinal obstruction	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—
Nausea	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—
Small intestinal obstruction	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—
Cerebrovascular accident	Nervous system disorders	—	—	—	—	—	—	—	—	—	—	—
Anaemia	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—	—	—	—
Myocardial infarction	Cardiac disorders	—	—	—	—	—	—	—	—	—	—	—
Abdominal pain	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—
Ascites	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—
Duodenal obstruction	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—
Lower gastrointestinal haemorrhage	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—
Non-cardiac chest pain	General disorders	—	—	—	—	—	—	—	—	—	—	—
Pyrexia	General disorders	—	—	—	—	—	—	—	—	—	—	—
Biliary obstruction	Hepatobiliary disorders	—	—	—	—	—	—	—	—	—	—	—
Jaundice cholestatic	Hepatobiliary disorders	—	—	—	—	—	—	—	—	—	—	—
Pneumonia	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—
Pyelonephritis	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—
Sepsis	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—
Upper respiratory tract infection	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—
Femur fracture	Injury, poisoning and procedural complications	—	—	—	—	—	—	—	—	—	—	—
Dehydration	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—	—	—	—
Arthralgia	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—	—
Flank pain	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—	—
Pathological fracture	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—	—

Other adverse events (180 terms — click to expand)

Reaction	System	Part 1 Schedule A - BMS-98…	Part 1 Schedule A - BMS-98…	Part 1 Schedule A - BMS-98…	Part 1 Schedule A - BMS-98…	Part 1 Schedule A - BMS-98…	Part 1 Schedule B - BMS-98…	Part 1 Schedule B - BMS-98…	Part 1 Schedule C - BMS-98…	Part 1 Schedule C - BMS-98…	Part 1 Schedule C - BMS-98…	Part 2 Schedule A
Diarrhoea	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—
Fatigue	General disorders	—	—	—	—	—	—	—	—	—	—	—
Anaemia	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—	—	—	—
Thrombocytopenia	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—	—	—	—
Nausea	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—
Decreased appetite	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—	—	—	—
Dyspnoea	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—	—	—
Constipation	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—
Weight decreased	Investigations	—	—	—	—	—	—	—	—	—	—	—
Dysgeusia	Nervous system disorders	—	—	—	—	—	—	—	—	—	—	—
Oedema peripheral	General disorders	—	—	—	—	—	—	—	—	—	—	—
Blood bilirubin increased	Investigations	—	—	—	—	—	—	—	—	—	—	—
Headache	Nervous system disorders	—	—	—	—	—	—	—	—	—	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—	—	—
Epistaxis	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—	—	—
Dry skin	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—	—	—	—	—
Abdominal pain	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—
Abdominal pain upper	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—
Dry mouth	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—
Asthenia	General disorders	—	—	—	—	—	—	—	—	—	—	—
Hyperbilirubinaemia	Hepatobiliary disorders	—	—	—	—	—	—	—	—	—	—	—
Urinary tract infection	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—
Lipase increased	Investigations	—	—	—	—	—	—	—	—	—	—	—
Hypomagnesaemia	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—	—	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—	—
Muscle spasms	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—	—
Rash	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—	—	—	—	—
Abdominal distension	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—
Malaise	General disorders	—	—	—	—	—	—	—	—	—	—	—
Pain	General disorders	—	—	—	—	—	—	—	—	—	—	—
Influenza	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—
Upper respiratory tract infection	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—
Contusion	Injury, poisoning and procedural complications	—	—	—	—	—	—	—	—	—	—	—
Alanine aminotransferase increased	Investigations	—	—	—	—	—	—	—	—	—	—	—
Aspartate aminotransferase increased	Investigations	—	—	—	—	—	—	—	—	—	—	—
International normalised ratio increased	Investigations	—	—	—	—	—	—	—	—	—	—	—
Dehydration	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—	—	—	—
Hypokalaemia	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—	—	—	—
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—	—

Most-reported serious reactions: Malignant neoplasm progression, Thrombocytopenia, Intestinal obstruction, Nausea, Small intestinal obstruction, Cerebrovascular accident, Anaemia, Myocardial infarction.

Data from ClinicalTrials.gov NCT02419417 adverse events section.

Sponsor's own description

The purpose of this study is to determine the safety, tolerability, pharmacokinetics, and pharmacodynamics of BMS-986158 in subjects with select advanced cancers

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Targeting transcription factors in cancer - from undruggable to reality.
   Bushweller JH. · · 2019 · cited 741× · PMID 31511663 · DOI 10.1038/s41568-019-0196-7
2. Epigenetic regulation in human cancer: the potential role of epi-drug in cancer therapy.
   Lu Y, Chan YT, Tan HY, Li S, et al · · 2020 · cited 318× · PMID 32340605 · DOI 10.1186/s12943-020-01197-3
3. Achieving clinical success with BET inhibitors as anti-cancer agents.
   Shorstova T, Foulkes WD, Witcher M. · · 2021 · cited 272× · PMID 33723398 · DOI 10.1038/s41416-021-01321-0
4. BRD4 Inhibition Is Synthetic Lethal with PARP Inhibitors through the Induction of Homologous Recombination Deficiency.
   Sun C, Yin J, Fang Y, Chen J, et al · · 2018 · cited 257× · PMID 29533782 · DOI 10.1016/j.ccell.2018.01.019
5. Epigenetic regulation in the tumor microenvironment: molecular mechanisms and therapeutic targets.
   Yang J, Xu J, Wang W, Zhang B, et al · · 2023 · cited 251× · PMID 37217462 · DOI 10.1038/s41392-023-01480-x
6. Drug Discovery Targeting Bromodomain-Containing Protein 4.
   Liu Z, Wang P, Chen H, Wold EA, et al · · 2017 · cited 234× · PMID 28195723 · DOI 10.1021/acs.jmedchem.6b01761
7. Bromodomain and extra-terminal motif inhibitors: a review of preclinical and clinical advances in cancer therapy.
   Alqahtani A, Choucair K, Ashraf M, Hammouda DM, et al · · 2019 · cited 198× · PMID 30906568 · DOI 10.4155/fsoa-2018-0115
8. Bromodomain inhibitors and cancer therapy: From structures to applications.
   Pérez-Salvia M, Esteller M. · · 2017 · cited 197× · PMID 27911230 · DOI 10.1080/15592294.2016.1265710