A Study of BMS-986488 as Monotherapy and Combination Therapy in Participants With Advanced Malignant Tumors
- Summary
- This purpose of this study is to determine if experimental treatment with BMS-986488, alone, or in combinations is safe, tolerable, and has anti-cancer activity in patients with advanced malignant tumors.
- Short title
- A Study of BMS-986488 as Monotherapy and Combination Therapy in Participants With Advanced Malignant Tumors
- Official title
- A Phase 1/1b Open-label Study of BMS-986488 as Monotherapy and Combination Therapy in Participants With Advanced Malignant Tumors
- Control arm
- Open label
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Completion date
- 2027-10-15
- First posted
- 2025-01-08
- Registry last updated
- 2026-07-29
- Primary completion date
- 2027-10-15
- Start date
- 2025-03-25
- Participants
- Participant count basis
- Estimated
- Planned participants
- Protocol amendments
- Number of sites
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- Bristol-Myers Squibb
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT06764771
- ClinicalTrials.gov ID
- NCT06764771
- Registry record
- Open registry record
- Allocation
- Not randomised
- Model
- Sequential
- Purpose
- Treatment
- Masking
- No masking
Number of participants with Adverse Events (AEs)
Timeframe: Until the end of the Safety Follow-up period (up to approximately 100 days after last dose)
Number of participants with Serious AEs (SAEs)
Timeframe: Until the end of the Safety Follow-up period (up to approximately 100 days after last dose)
Number of participants with AEs meeting protocol-defined Dose-Limiting Toxicity (DLT) criteria
Timeframe: From first dose of study treatment until end of cycle 1 (1 Cycle = 28 Days)
Number of participants with AEs leading to discontinuation
Timeframe: Until the end of the Safety Follow-up period (up to approximately 100 days after last dose)
Number of deaths
Timeframe: From time of informed consent up to 52 weeks after end of treatment visit
Maximum observed plasma concentration (Cmax)
Timeframe: Until Cycle 4, Day 1 (1 Cycle = 28 Days)
Time of maximum observed concentration (Tmax)
Timeframe: Until Cycle 4, Day 1 (1 Cycle = 28 Days)
Area under the concentration-time curve in 1 dosing interval (AUC(TAU))
Timeframe: Until Cycle 4, Day 1 (1 Cycle = 28 Days)
Objective response rate (ORR)
Timeframe: From time of informed consent up to 52 weeks after end of treatment visit
Defined as the proportion of participants who achieve a best overall response (BOR) of complete response (CR) or partial response (PR) assessed by the investigator using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)
Disease control rate (DCR)
Timeframe: From time of informed consent up to 52 weeks after end of treatment visit
Defined as the proportion of participants who achieve a best response of CR, PR, or stable disease (SD) assessed by the investigator using RECIST v1.1
Duration of response (DOR)
Timeframe: From time of informed consent up to 52 weeks after end of treatment visit
Defined as the time between the date of first documented response (CR or PR) to the date of the first documented disease progression as assessed by the investigator using RECIST v1.1 or death due to any cause, whichever occurs first
- Sex
- All
- Age groups
- Adults, Older adults
- Minimum age
- 18 Years
- Healthy volunteers
- No
-
Participant must be ≥ 18 years of age.
-
Histologically confirmed diagnosis of a locally advanced and unresectable or metastatic solid tumor malignancy with any of the following tumor types:.
-
Part 1A: clear-cell renal cell carcinoma (ccRCC), clear-cell ovarian cancer (ccOC), non-small cell lung cancer (NSCLC), colorectal cancer (CRC), and pancreatic ductal adenocarcinoma (PDAC).
-
Parts 2A, 1D, 2D: ccRCC.
i) Part 1B: solid tumors with KRAS G12C mutation.
ii) Part 2B: NSCLC with KRAS G12C mutation.
iii) Parts 1C, 2C: colorectal cancer (CRC) with KRAS G12C mutation.
- Participants must have an Eastern Cooperative Oncology Groups (ECOG) Performance Status of 0 or 1.
- Participants must have measurable disease per RECIST v1.1.
-
Untreated central nervous system (CNS) metastases.
-
Leptomeningeal metastasis (carcinomatous meningitis).
-
Impaired cardiac function or clinically significant cardiac disease.
-
For Parts 1B, 1C, 2B, 2C only (combination with adagrasib):.
i) History of pneumonitis or interstitial lung disease (ILD).
ii) History of prior severe cutaneous adverse reactions (SCARs), including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN).
- Other protocol-defined inclusion/exclusion criteria apply.
- John Theurer Cancer Center at Hackensack University Medical CenterHackensack, United StatesRecruiting
- Local Institution - 0020Allentown, United StatesActive, not recruiting
- The West Clinic, PLLC dba West Cancer CenterGermantown, United StatesRecruiting
- Local Institution - 0025Dallas, United StatesWithdrawn
- Local Institution - 0031Brisbane, AustraliaActive, not recruiting
- BC Cancer VancouverVancouver, CanadaRecruiting
- Local Institution - 0015Montreal, CanadaNot yet recruiting
- Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-JésusQuébec, CanadaRecruiting
- Related resource (www.bms.com)
- Related resource (www.bmsclinicaltrials.com)