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
Study Identifier:
CA2560001
CT.gov Identifier:
EudraCT Identifier:
EU Trial (CTIS) Number:
Study Contact Information:
Recruiting
Considering participating in a START clinical trial?
Study Summary
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
To find out if BMS-986523 is safe and tolerable and to figure out the best dose and schedule for using BMS-986523 alone or with pembrolizumab, cetuximab, or gemcitabine plus nab-paclitaxel in participants with advanced solid malignancies that have KRAS alterations.
Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
Unspecified Cancer
Non-Small Cell Lung Cancer
Bowel (Colorectal)
Pancreas
Phase
The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
Phase I/II
Sex
Female & Male
Age
18+ years
Study Drug
Drug: EXPERIMENTAL: Arm A
Read More
Drug: Drug: BMS-986523
Drug: Specified dose on specified days
Drug: EXPERIMENTAL: Arm B
Drug: EXPERIMENTAL: Arm C
Drug: EXPERIMENTAL: Arm D
Drug: Drug: Pembrolizumab
Drug: EXPERIMENTAL: Arm E
Drug: Drug: Cetuximab
Drug: EXPERIMENTAL: Arm F
Drug: Drug: Gemcitabine
Drug: Drug: Nab-Paclitaxel
Study Status
Indicates the current recruitment status or the expanded access status
Recruiting
Requirements information
Inclusion 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.
- 1Histologically confirmed diagnosis of a locally advanced and unresectable or metastatic solid tumor malignancy with a known KRAS alteration (mutation or amplification): Part 1A: All tumor types (Arms A and B); Part 2A: NSCLC, CRC, and PDAC (Arm C); Part 1B: NSCLC (Arm D), CRC (Arm E), and PDAC (Arm F).
- 2Participants should have previously received, be ineligible for, or declined (after having been provided adequate information to make an informed decision) select standard of care treatments depending on their assigned study arm.
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.
- 1Untreated central nervous system (CNS) metastases.Spanish:Metástasis en el sistema nervioso central (SNC) sin tratar.
- 2Concurrent malignancy (present during screening) requiring treatment or history of prior malignancy active within 2 years prior to treatment
- 3Prior treatment with a (K)RAS directed therapy including approved treatments and investigational agents.
Clinical Study Information for Healthcare Providers
By clicking the button below you will find in-depth information about this clinical trial, including study design, primary and secondary endpoints, and more. This information is intended for healthcare professionals seeking to review the scientific and operational aspects of the study.
Study Locations
Location
Investigator
Status
Condition(s) Treated at Site
Location
START Mountain Region
West Valley City, UT, United States, 84119
Investigator
Justin Call
Status
Recruiting
Condition(s) Treated at Site
Unspecified Cancer
Non-Small Cell Lung Cancer
Bowel (Colorectal)
Pancreas