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A Study to Assess Safety, Tolerability and Drug Levels of BMS-986504 in Participants With Advanced Solid Tumors

Bristol-Myers Squibb (BMS) logo

Bristol-Myers Squibb (BMS)

Status and phase

Enrolling
Phase 1

Conditions

Advanced Solid Tumors

Treatments

Drug: BMS-986504

Study type

Interventional

Funder types

Industry

Identifiers

NCT07077434
CA240-0010

Details and patient eligibility

About

The purpose of this study is to evaluate the safety, tolerability and drug levels of BMS-986504 in participants with advanced solid tumors.

Enrollment

32 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Participants must have histologically confirmed diagnosis of a solid tumor malignancy with homozygous deletion of the MTAP gene detected in tumor tissue.
  • Participants must have unresectable or metastatic disease not amenable to curative therapies after progression on prior therapies at the time of enrollment.
  • Participants must have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Participants must have presence of at least one measurable tumor lesion per RECIST 1.1 at baseline.

Exclusion criteria

  • Participants must not have prior treatment with a Protein arginine methyltransferase 5 (PRMT5) or Methionine adenosyltransferase 2A (MAT2A) inhibitor.
  • Participants must not have active brain metastases or carcinomatous meningitis.
  • Participants must not have a history of gastrointestinal disease or other gastrointestinal conditions (e.g., uncontrolled nausea, vomiting, malabsorption syndrome) likely to alter absorption of study treatment or result in inability to swallow oral medications.
  • Participants must not have known severe hypersensitivity to study treatment and/or any of its excipients.
  • Other protocol-defined Inclusion/Exclusion criteria apply.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

32 participants in 1 patient group

BMS-986504 Arm
Experimental group
Treatment:
Drug: BMS-986504

Trial contacts and locations

12

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Central trial contact

First line of the email MUST contain the NCT# and Site #.; BMS Study Connect Contact Center, www.BMSStudyConnect.com

Data sourced from clinicaltrials.gov

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