A Study to Evaluate the Safety, Tolerability, and Efficacy of BMS-986523 Alone and in Combination With Anti-Cancer Agents in Participants With Advanced Solid Malignancies
The registry record from ClinicalTrials.gov (public domain): summary, interventions, outcomes and eligibility. Questions are answered only with quotes from this document. Source: ClinicalTrials.gov, retrieved 2026-11-05.
Ongoing
Record metadata
- Phase
- Phase 1 / Phase 2
- Status
- Recruiting
- Start
- 2025-11-25
- End
- 2028-10-13
- Enrollment
- 252
- Sites
- 8
- Sponsor class
- INDUSTRY
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Source text
Brief summary · public domain (ClinicalTrials.gov) · T1
The purpose of this study is to evaluate the safety, tolerability, and efficacy of BMS-986523 alone and in combination with anti-cancer agents in participants with advanced solid malignancies
Intervention · public domain (ClinicalTrials.gov) · T1
Drug: BMS-986523. Specified dose on specified days
Intervention · public domain (ClinicalTrials.gov) · T1
Drug: Gemcitabine. Specified dose on specified days
Intervention · public domain (ClinicalTrials.gov) · T1
Drug: Nab-Paclitaxel. Specified dose on specified days
Intervention · public domain (ClinicalTrials.gov) · T1
Drug: Cetuximab. Specified dose on specified days
Intervention · public domain (ClinicalTrials.gov) · T1
Drug: Pembrolizumab. Specified dose on specified days
Arm · public domain (ClinicalTrials.gov) · T1
Arm A (experimental):
Arm · public domain (ClinicalTrials.gov) · T1
Arm B (experimental):
Arm · public domain (ClinicalTrials.gov) · T1
Arm C (experimental):
Arm · public domain (ClinicalTrials.gov) · T1
Arm D (experimental):
Arm · public domain (ClinicalTrials.gov) · T1
Arm E (experimental):
Arm · public domain (ClinicalTrials.gov) · T1
Arm F (experimental):
Primary outcome · public domain (ClinicalTrials.gov) · T1
Number of participants with adverse events (AEs). Time frame: Up to 3 years.
Primary outcome · public domain (ClinicalTrials.gov) · T1
Number of participants with serious adverse events (SAEs). Time frame: Up to 3 years.
Primary outcome · public domain (ClinicalTrials.gov) · T1
Number of participants with AEs meeting protocol-defined dose limiting toxicity (DLT) criteria. Time frame: Up to 3 years.
Primary outcome · public domain (ClinicalTrials.gov) · T1
Number of participants with AEs leading to discontinuation. Time frame: Up to 3 years.
Primary outcome · public domain (ClinicalTrials.gov) · T1
Number of deaths. Time frame: Up to 3 years.
Secondary outcome · public domain (ClinicalTrials.gov) · T1
Objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as assessed by the investigator.. Time frame: Up to 3 years.
Secondary outcome · public domain (ClinicalTrials.gov) · T1
Duration of response (DOR) per RECIST v1.1 as assessed by the investigator.. Time frame: Up to 3 years.
Secondary outcome · public domain (ClinicalTrials.gov) · T1
Maximum observed plasma concentration (Cmax). Time frame: Up to 3 years.
Secondary outcome · public domain (ClinicalTrials.gov) · T1
Time of maximum observed plasma concentration (Tmax). Time frame: Up to 3 years.
Secondary outcome · public domain (ClinicalTrials.gov) · T1
Area under the concentration-time curve in 1 dosing interval (AUC(TAU)). Time frame: Up to 3 years.
Eligibility · public domain (ClinicalTrials.gov) · T1
Inclusion Criteria * Participants must have a histologically confirmed diagnosis of a locally advanced and unresectable or metastatic solid tumor malignancy with a known Kirsten rat sarcoma viral oncogene homolog (KRAS) alteration (mutation or amplification). * Participants must, for Arm D, have a PD-L1 expression (≥50%). * Participants must have previously received, be ineligible for, or decline (after having been provided adequate information to make an informed decision) the protocol defined standard of care (SoC) treatments. Exclusion Criteria * Participants must not have untreated central nervous system (CNS) metastases. * Participants must not have concurrent malignancy (present during screening) requiring treatment or history of prior malignancy active within 2 years prior to treatment. * Participants must not have a history of, or any evidence of, interstitial lung disease or active, non-infectious pneumonitis. A history of radiation pneumonitis in the radiation field is permitted. * Participants must not have a 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.
Enrollment · public domain (ClinicalTrials.gov) · T1
Enrollment: 252 participants (estimated).