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

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorBristol-Myers Squibb

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • BMS-986507
  • Osimertinib
  • Pembrolizumab
  • Nivolumab
  • Pumitamig

Treatment groups

416 Participants
are divided into 5 treatment groups

Locations

64
Australia
Liverpool Hospital2170, LiverpoolNew South Wales, Australia
Princess Alexandra Hospital4102, WoolloongabbaQueensland, Australia
Local Institution - 01083002, East MelbourneVictoria, Australia
Local Institution - 01016008, SubiacoWestern Australia, Australia

Sponsors and collaborators

Bristol-Myers Squibb

Lead sponsor