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
Recruiting · NCT07223047 · Interventional (participants receive a specific treatment) · Lead sponsor: Bristol-Myers Squibb
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 1, Phase 2
Study type
Interventional (participants receive a specific treatment)
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 it is running
8 locations listed across 4 US states.
- Johns Hopkins Hospital - Baltimore, Maryland, United States
- NEXT Oncology - San Antonio, Texas, United States
- START Mountain Region - West Valley City, Utah, United States
- NEXT Virginia - Fairfax, Virginia, United States
- Local Institution - 0006 - Badalona, Barcelona [Barcelona], Spain
- BC Cancer Vancouver - Vancouver, British Columbia, Canada
- Local Institution - 0008 - Hortaleza, Madrid, Spain
- Princess Margaret Cancer Centre - Toronto, Ontario, Canada