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Evaluating a new drug combination for advanced lung cancer

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

Phase1; Phase2 Interventional Bristol-Myers Squibb · NCT06618287

This study is testing a new combination of drugs for adults with advanced lung cancer to see if it is safe and effective when used with existing treatments.

Quick facts

PhasePhase1; Phase2
Study typeInterventional
Enrollment416 (estimated)
Ages18 Years and up
SexAll
SponsorBristol-Myers Squibb Industry-sponsored
Locations64 sites (Birmingham, Alabama and 63 other locations)
Trial IDNCT06618287 on ClinicalTrials.gov

What this trial studies

This study aims to assess the safety, tolerability, drug levels, and preliminary efficacy of a combination of BMS-986507 with other treatments in adults with advanced solid tumors, specifically targeting lung cancer. Participants will receive the investigational drug alongside established therapies like Osimertinib and Pembrolizumab. The study will include patients with measurable lesions and will monitor their response to the treatment over time. The goal is to gather data that could inform future treatment options for this patient population.

Who should consider this trial

Good fit: Ideal candidates for this study are adults with advanced non-small cell lung cancer who have measurable lesions and a good performance status.

Not a fit: Patients with mixed small cell and non-small cell lung cancer or untreated symptomatic central nervous system metastases may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new effective treatment option for patients with advanced lung cancer.

How similar studies have performed: Other studies have shown promise with similar drug combinations in treating advanced lung cancer, indicating potential for success.

Eligibility criteria

Show full inclusion / exclusion 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.

Where this trial is running

Birmingham, Alabama and 63 other locations

+14 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
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Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.