BMS-986523 alone and with other cancer medicines for advanced KRAS-altered solid tumors
A Phase 1/2a, Open-Label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of BMS-986523 As Monotherapy and in Combination With Anti-Cancer Agents in Participants With Advanced Solid Malignancies
This treatment tests whether BMS-986523, alone or combined with chemotherapy or immunotherapy, helps people with advanced KRAS-altered lung, colorectal, or pancreatic cancers.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 252 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Bristol-Myers Squibb Industry-sponsored |
| Drugs / interventions | radiation |
| Locations | 8 sites (Baltimore, Maryland and 7 other locations) |
| Trial ID | NCT07223047 on ClinicalTrials.gov |
What this trial studies
Bristol-Myers Squibb is running a phase 1/2 program of the investigational agent BMS-986523 given alone or together with agents such as gemcitabine, nab‑paclitaxel, cetuximab, or pembrolizumab in adults with unresectable or metastatic solid tumors that have KRAS alterations. Phase 1 focuses on safety, tolerability, and dose-finding while phase 2 explores preliminary anti-tumor activity across disease-specific arms including NSCLC, CRC, and PDAC, with one arm requiring PD-L1 ≥50%. Key outcomes include adverse events, tolerability, and measures of tumor response and disease control. Eligible participants must have a confirmed KRAS mutation or amplification and have received, be ineligible for, or decline standard treatments.
Who should consider this trial
Good fit: Adults with unresectable or metastatic NSCLC, colorectal cancer, or pancreatic ductal adenocarcinoma who have a confirmed KRAS alteration and who have received, are ineligible for, or decline standard therapies (with PD-L1 ≥50% required for one arm).
Not a fit: Patients with untreated central nervous system metastases, active interstitial lung disease or recent other malignancies, or those without a KRAS alteration are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, this approach could offer a new targeted treatment option for patients with KRAS-altered advanced solid tumors and potentially improve response rates or survival.
How similar studies have performed: Related targeted and combination approaches have shown benefit in certain KRAS-selected groups (for example KRAS G12C inhibitors), but BMS-986523 is investigational and its effectiveness across KRAS alterations remains exploratory.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Baltimore, Maryland and 7 other locations
- Local Institution - 0009 — Baltimore, Maryland, United States (Not_yet_recruiting)
- NEXT Oncology — San Antonio, Texas, United States (Recruiting)
- START Mountain Region — West Valley City, Utah, United States (Recruiting)
- NEXT Virginia — Fairfax, Virginia, United States (Recruiting)
- Local Institution - 0002 — Vancouver, British Columbia, Canada (Not_yet_recruiting)
- Princess Margaret Cancer Centre — Toronto, Ontario, Canada (Recruiting)
- Local Institution - 0006 — Badalona, Barcelona [Barcelona], Spain (Not_yet_recruiting)
- Local Institution - 0008 — Hortaleza, Madrid, Spain (Not_yet_recruiting)
Study contacts
- Study coordinator: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
- Email: Clinical.Trials@bms.com
- Phone: 855-907-3286
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.