Actively Recruiting
A Phase 1/2a, Open-Label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of BMS-986523 Alone and With Anti-Cancer Agents in Advanced Solid Malignancies
Led by Bristol-Myers Squibb · Updated on 2026-05-28
252
Participants Needed
8
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, and effectiveness of a drug called BMS-986523 alone and in combination with other anti-cancer drugs in people with advanced solid tumors, including non-small cell lung cancer, colorectal cancer, and pancreatic ductal adenocarcinoma. The study is an open-label, phase 1/2a trial sponsored by Bristol-Myers Squibb, focusing on participants with specific genetic alterations (KRAS mutations or amplifications) and advanced disease stages. Participants will receive BMS-986523 alone or combined with other anti-cancer agents such as Gemcitabine, Nab-Paclitaxel, Cetuximab, or Pembrolizumab, each given at specified doses on designated days. The study includes multiple treatment groups (arms A through F) with no random assignment or masking, allowing researchers to observe the drug effects in different combinations. The trial will monitor participants for up to three years to assess safety and treatment responses. During the study, participants will undergo regular assessments to track adverse events, serious side effects, and any toxicities related to the treatments. Researchers will also evaluate the tumor response using standardized criteria and measure drug levels in the blood. Safety monitoring includes checking for events leading to treatment discontinuation or death. Participants will be followed for up to three years to collect comprehensive data on treatment impact and tolerability.
CONDITIONS
Brief Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Diagnosed with locally advanced, unresectable, or metastatic solid tumor malignancy with a KRAS mutation or amplification
- For Arm D participants, PD-L1 expression must be 50% or higher
- Previously received, are ineligible for, or have declined standard of care treatments
You will not qualify if you...
- Untreated central nervous system metastases
- Concurrent malignancy requiring treatment or prior malignancy active within 2 years
- History or evidence of interstitial lung disease or active, non-infectious pneumonitis (radiation pneumonitis allowed in treated area)
- History of severe cutaneous adverse reactions such as Stevens-Johnson Syndrome or toxic epidermal necrolysis
- Other protocol-defined exclusion criteria
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 3 years or until discontinuation
Participants receive specified doses of BMS-986523 alone or in combination with other anti-cancer agents according to their assigned arm.
Visit frequency varies based on treatment schedule and participant response
Duration - Up to 3 years
Participants are monitored for safety, efficacy, and survival outcomes after treatment ends.
Periodic visits depending on participant status
Trial Site Locations
Total: 8 locations
1
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
Actively Recruiting
2
NEXT Oncology
San Antonio, Texas, United States, 78229
Actively Recruiting
3
START Mountain Region
West Valley City, Utah, United States, 84119
Actively Recruiting
4
NEXT Virginia
Fairfax, Virginia, United States, 22031
Actively Recruiting
5
BC Cancer Vancouver
Vancouver, British Columbia, Canada, V5Z 4E6
Actively Recruiting
6
Princess Margaret Cancer Centre
Toronto, Ontario, Canada, M5G 2M9
Actively Recruiting
7
Local Institution - 0006
Badalona, Barcelona [Barcelona], Spain, 08916
Not Yet Recruiting
8
Local Institution - 0008
Hortaleza, Madrid, Spain, 28050
Not Yet Recruiting
Research Team
B
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
F
First line of the email MUST contain NCT # and Site #.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
6
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