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RecruitingLast updated: 5 August 2026

CA244-0001: Evaluating a new drug called BMS-986507 when given with other cancer treatments for people with advanced or metastatic non-small cell lung cancer or breast cancer (including TNBC and ER-low, HER2-negative breast 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

Trial purpose

Medical clipboardCancer treatment

Tumor type

Multi-Cancer Multi-Cancer

Age

People18+

Trial acronym

CA244-0001

Clinical summary

Summary

This is an early phase clinical trial testing a drug called BMS-986507 (also known as BL-B01D1) in combination with other treatments for people with advanced lung cancer or breast cancer.

The study aims to determine:

  • How safe these treatment combinations are
  • What side effects may occur
  • How the body processes the medicines
  • Whether the treatments show signs of helping control cancer

Who can take part?
The trial is recruiting adults with specific types of locally advanced, recurrent, inoperable or metastatic cancer:

  • Group A: people with non-small cell lung cancer (NSCLC) with specific EGFR mutations, including exon 19 deletion or exon 21 L858R mutation
  • Group B: people with advanced NSCLC
  • Group C: people with triple negative breast cancer (TNBC) or ER-low, HER2-negative breast cancer
  • Group D: people with advanced TNBC
  • Group E: people with NSCLC that is not suitable for treatment with the aim of cure
Depending on the treatment group, participants will receive BMS-986507 in combination with another anti-cancer medicine, such as osimertinib (Group A), pembrolizumab (Group B), nivolumab (Group C), or pumitamig (Groups D and E).

Conditions

This trial is treating people with locally advanced, metastatic or recurrent non-small cell lung cancer, triple negative breast cancer, or ER-low, HER2-negative breast cancer

Eligibility

Inclusion

  • 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

  • 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.

Inclusion

  • You have had treatment, but your cancer has come back (relapsed or recurrent).
  • Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).
  • Your cancer has not spread to other parts of the body, but it is not possible to perform surgery to remove it (unresectable).

Exclusion

  • You have certain types of non-cancer medical conditions.
Message

Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.

Participating hospitals

Recruiting hospitals

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More information

Trial Identifiers

Information on this page is partially produced from ClinicalTrials.gov, EU Clinical Trials Register *. View further details about this trial on the registry via the links below:

  • NCT06618287 *
  • 2024-514947-27 *
  • CA244-0001; U1111-1308-2752

Trial sponsor

Bristol-Myers Squibb

Scientific Title

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

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