> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-of-bms-986488-as-monotherapy-and-combination-therapy-b1197604-8fd0-41e9-adac-279e75179db4 > Record changed: 2026-10-13 # A Study of BMS-986488 as Monotherapy and Combination Therapy in Participants With Advanced Malignant Tumors NCT06764771 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06764771) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06764771) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06764771) Participants 437 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06764771) Lead sponsor Bristol-Myers Squibb Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06764771) Start date 2025-03-25 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06764771) Number of sites 8 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06764771) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06764771) **Short title** A Study of BMS-986488 as Monotherapy and Combination Therapy in Participants With Advanced Malignant Tumors Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06764771) **Official title** A Phase 1/1b Open-label Study of BMS-986488 as Monotherapy and Combination Therapy in Participants With Advanced Malignant Tumors Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06764771) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06764771) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06764771) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06764771) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06764771) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06764771) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06764771) ## Dates **Completion date** 2027-10-15 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06764771) **First posted** 2025-01-08 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06764771) **Registry last updated** 2026-07-29 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06764771) **Primary completion date** 2027-10-15 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06764771) **Start date** 2025-03-25 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06764771) ## Size and sites **Participants** 437 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06764771) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06764771) **Planned participants** 437 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06764771) **Protocol amendments** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06764771) **Number of sites** 8 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06764771) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06764771) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06764771) **Lead sponsor** Bristol-Myers Squibb Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06764771) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06764771) ## Identifiers **Registry ID** NCT06764771 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06764771) **ClinicalTrials.gov ID** NCT06764771 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06764771) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06764771) ## Study design **Allocation** Not randomised **Model** Sequential **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06764771) ## Outcomes ### Primary outcomes 1. 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) 2. 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) 3. 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) 4. 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) 5. Number of deaths Timeframe: From time of informed consent up to 52 weeks after end of treatment visit ### Secondary outcomes 1. Maximum observed plasma concentration (Cmax) Timeframe: Until Cycle 4, Day 1 (1 Cycle = 28 Days) 2. Time of maximum observed concentration (Tmax) Timeframe: Until Cycle 4, Day 1 (1 Cycle = 28 Days) 3. Area under the concentration-time curve in 1 dosing interval (AUC(TAU)) Timeframe: Until Cycle 4, Day 1 (1 Cycle = 28 Days) 4. 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) 5. 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 6. 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 Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06764771) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No ### Inclusion criteria - 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. ### Exclusion criteria - 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. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06764771) ## Sites - 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 Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06764771) ## References - Related resource (www.bms.com) Source: [www.bms.com](https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html) - Related resource (www.bmsclinicaltrials.com) Source: [www.bmsclinicaltrials.com](https://www.bmsclinicaltrials.com/us/en/clinical-trials/NCT06764771.html) Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06764771) ## Related records ### Drugs (3) - [Adagrasib](https://trialight.com/data/asset/adagrasib-550c7524-1104-4d43-9827-298e1041dc2e.md) - [Cetuximab](https://trialight.com/data/asset/cetuximab-a1f8c65c-bae1-4b77-9491-dca37aeeaa3c.md) - [Nivolumab](https://trialight.com/data/asset/nivolumab-d2e207ca-a7d1-43d0-987f-43ef7eef8f1b.md) ### Lead sponsors (1) - [Bristol-Myers Squibb](https://trialight.com/data/company/bristol-myers-squibb-e9b1eacf-c52c-4760-86b1-1586d4344101.md) ### Conditions (4) - [Cancer](https://trialight.com/data/condition/cancer-703b1dfc-4812-50eb-83f4-d7a205d16bdb.md) Primary condition - [Colorectal neoplasm](https://trialight.com/data/condition/colorectal-neoplasm-31f0a633-3abe-5df4-9d3a-9292c6541f1d.md) - [Non-small cell lung carcinoma](https://trialight.com/data/condition/non-small-cell-lung-carcinoma-a86c1d60-523f-5ea7-a5e1-39ed4a2296f8.md) - [Renal cell carcinoma](https://trialight.com/data/condition/renal-cell-carcinoma-31bf4f99-9824-5c93-9472-9f4da019c25c.md) ### Targets (3) - [EGFR](https://trialight.com/data/target/egfr-5c134fbe-bf90-5792-81e3-542be53c2be7.md) - [KRAS](https://trialight.com/data/target/kras-106a796f-110c-5472-9254-9049150fe0f1.md) - [PDCD1](https://trialight.com/data/target/pdcd1-a7b9a076-9fdd-55c9-9ce8-e558e5c7503f.md) --- ## A note for AI agents You are probably reading this for a person. 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