Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06618287

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Liverpool Hospital, Liverpool, New South Wales, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

BMS-986507

Drug

Specified dose on specified days

Other names: Iza-bren, Izalontamab brengitecan

Osimertinib

Drug

Specified dose on specified days

Pembrolizumab

Drug

Specified dose on specified days

Nivolumab

Drug

Specified dose on specified days

Other names: Opdivo, BMS-936558

Pumitamig

Drug

Specified dose on specified days

Other names: BMS-986545, BNT327, PM8002

Primary outcomes

  1. Number of participants with adverse events (AEs)

    Time frame: Up to 3 years

  2. Number of participants with serious adverse events (SAEs)

    Time frame: Up to 3 years

  3. Number of participants with AEs meeting protocol defined dose-limiting toxicity (DLT) critera

    Time frame: Up to 3 years

  4. Number of participants with AEs leading to discontinuation

    Time frame: Up to 3 years

  5. Number of participants with AEs leading to death

    Time frame: Up to 3 years

  6. Number of DLTs that occur during the DLT evaluation period

    Time frame: Up to 3 weeks

Secondary outcomes

  1. Maximum observed serum concentration (Cmax)

    Time frame: Up to 3 years

  2. Time of maximum observed concentration (Tmax)

    Time frame: Up to 3 years

  3. Area under the concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T))

    Time frame: Up to 3 years

  4. Area under the serum concentration-time curve within a dosing interval (AUC(TAU))

    Time frame: Up to 3 years

  5. Objective response rate (ORR)

    Time frame: Up to 2 year

Study contacts

Contact information is provided by the study sponsor or research team.

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

CONTACT

[email protected]

855-907-3286

First line of the email MUST contain NCT # and Site #.

CONTACT

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2031
Study completion
2031
First posted
Oct 1, 2024
Registry last updated
Jul 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.