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
Phase 1Phase 2Interventional Study
Advanced Solid MalignanciesNon-small Cell Lung Cancer (NSCLC)Colorectal Cancer (CRC)Pancreatic Ductal Adenocarcinoma (PDAC)
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 1/2
Study type
Interventional
Purpose
Treatment
Participants needed
252 (estimated)
Sponsor
Bristol-Myers Squibb · Industry
Who this trial is looking for
This trial is looking for people with certain advanced cancers who have a specific gene change. Participants will receive the study drug alone or with other cancer treatments to see how well it works and if it's safe.
Are You a Good Fit for This Trial?
You may be able to join if
I have a confirmed diagnosis of a certain advanced solid tumor.
I have a KRAS gene change.
I have received standard cancer treatments or I cannot take them.
You may not be able to join if
I have untreated central nervous system metastases.
I have another cancer that needs treatment.
I have a history of lung disease or certain lung reactions.
I have had severe skin reactions in the past.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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
Trial Locations
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Eligibility 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 …
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.
Contacts
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
First line of the email MUST contain NCT # and Site #.
CONTACT
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