RightFit
RecruitingPhase 1 / Phase 2

A Study to Evaluate the Safety, Tolerability, Drug Levels, and Preliminary Efficacy of BMS-986507 Combinations in Adult Participants With Advanced Solid Tumors

A Phase 1/2a, Open-label, Dose-finding Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of BMS-986507 (BL-B01D1) Combinations in Adult Participants With Advanced Solid Tumors

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-986507 with other drugs in adults with advanced solid tumors. It checks safety, side effects, drug levels in the body, and early signs of how well the treatment works.

The purpose of this study is to evaluate the safety, tolerability, drug levels, and preliminary efficacy of BMS-986507 combinations in adult participants with advanced solid tumors.

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

Eligibility

Who can join

  • Have at least one tumor that can be measured using the study’s rules.
  • Be fully active or able to do light work, even if hard physical activity is limited (ECOG score of 0 or 1).
  • Be expected to live at least 3 months after the first dose.
  • Group A: Have non-small cell lung cancer confirmed by a tissue test that has spread nearby or to other body parts. It must have an EGFR gene change, such as an exon 19 deletion or L858R. Other EGFR changes are also allowed.
  • Group B: Have non-small cell lung cancer confirmed by a tissue test that has spread nearby or to other body parts.
  • Group C: Have breast cancer confirmed by a tissue test that has spread nearby, returned and cannot be removed by surgery, or spread to other body parts. It must be triple-negative (lacking three cancer markers) or have low estrogen receptors and be HER2-negative.
  • Group D: Have triple-negative breast cancer that has spread nearby, returned and cannot be removed by surgery, or spread to other body parts. The most recent tissue test must confirm this using the study’s rules.
  • Group E: Have non-small cell lung cancer confirmed by a tissue test that has spread nearby or to other body parts and cannot be treated with the goal of a cure.

Who can't join

  • Have lung cancer with both small cell and non-small cell types.
  • Have a known EGFR gene change (Groups A, B, and E). This conflicts with the Group A rule above. Ask the study team to clarify.
  • Have a history of serious infections that keep coming back.
  • Have a history of severe heart disease.
  • Other study rules also apply.

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

Official eligibility criteria

Inclusion Criteria * Participants must have at least one measurable lesion per response evaluation criteria in solid tumors. * Participants must have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1. * Participants must have a life expectancy of at least 3 months at the time of the first dose. * Group A: Participants must have pathologically confirmed locally advanced or metastatic NSCLC with an EGFR exon 19 deletion or L858R mutation in exon 21, either alone or in combination with other EGFR mutations, which may include T790M in exon 20. Participants with other EGFR mutations (including but not limited to, exon 21 L861Q, exon 18 G719X, and exon 20 S768I mutations, etc.) will also be allowed * Group B: Participants must have pathologically confirmed locally advanced or metastatic NSCLC. * Group C: Participants must have pathologically confirmed locally-advanced, recurrent inoperable, or metastatic TNBC or ER-low, HER2-negative BC. * Group D: Participants must have pathologically confirmed locally-advanced, recurrent inoperable, or metastatic TNBC per ASCO/CAP criteria, based on the most recently analyzed biopsy or another pathology specimen. * Group E: Participants must have pathologically confirmed locally advanced or metastatic NSCLC, not amenable to treatment in curative intent. Exclusion Criteria * Participants must not have any mixed Small Cell Lung Cancer (SCLC) and Non-Small Cell Lung Cancer (NSCLC) histology. * Participants with known mutations in EGFR will be excluded (Group A,B and E). * Participants must not have a history of serious recurrent infections. * Participants must not have a history of severe heart disease. * Other protocol-defined Inclusion/Exclusion criteria apply.

Study sites (14)

AL

FL

  • University of Miami Hospital and Clinics, Sylvester Cancer Center · Miami, FL 33136Gilberto DE LIMA LOPES JUNIOR, Site 0009 · Study contact · 305-243-1086More trials in Miami

IA

MO

NJ

OH

OR

PA

TN

TX

WA