RightFit
RecruitingPhase 1 / Phase 2

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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests BMS-986523 alone and with other cancer drugs in people with advanced solid tumors that have a KRAS gene change. It looks at how safe the treatment is, how well people handle side effects, and how well it works.

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

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • A tissue test must confirm a solid tumor that has spread nearby and cannot be removed by surgery, or has spread to other parts of the body.
  • The tumor must have a known change in the KRAS gene, such as a mutation or extra copies of the gene.
  • For study group D, the tumor must have a PD-L1 protein test result of at least 50%.
  • You must have received the standard treatments listed in the study plan, be unable to receive them, or choose not to receive them after getting enough information to decide.

Who can't join

  • Cancer that has spread to the brain or spinal cord and has not been treated.
  • Another cancer that needs treatment during screening, or a past cancer that was active within 2 years before study treatment.
  • Past or current interstitial lung disease (lung damage or scarring), or active pneumonitis (lung swelling) not caused by an infection. Past lung swelling from radiation is allowed if it stayed in the area treated with radiation.
  • A history of severe skin reactions, including Stevens-Johnson syndrome or toxic epidermal necrolysis, which can cause blistering and peeling skin.
  • Other study rules for who can and cannot join also apply.

Simplified for readability. The official criteria below are what the study team uses.

Official 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 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.

Study sites (4)

MD

TX

UT

VA