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Clinical Trials/EUCTR2021-001188-26-DE
EUCTR2021-001188-26-DEActive, not recruitingPhase 1

A Phase 1/2 Study of BMS-986340 as Monotherapy and in Combination with Nivolumab or Docetaxel in Participants with Advanced Solid Tumors

Bristol-Myers Squibb International Corporation0 sites277 target enrollmentStarted: November 10, 2021Last updated:
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Conditions
Drugs

Trial Snapshot

Phase
Phase 1
Status
Active, not recruiting
Enrollment
277
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility Criteria

Sex
All

Inclusion Criteria

  • •Fresh pre-treatment and on-treatment tumor biopsy must be provided for biomarker analysis
  • •Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and at least 1 lesion accessible for biopsy
  • •Eastern Cooperative Oncology Group Performance Status of 0 or 1
  • •Radiographically documented progressive disease on or after the most recent therapy
  • •Received standard-of-care therapies, including an available programmed death (ligand)-1 inhibitor known to be effective in the tumor type for which they are being evaluated (except for Part 1C, where participants with prior docetaxel use for the advanced/metastatic setting will be excluded)
  • •Participants must have advanced or metastatic disease, and have received, be refractory to, not be a candidate for, or be intolerant to existing therapies known to provide clinical benefit for the condition of the participant. Eligible tumor types for each Part are listed below:
  • •- Parts 1A and 1B: NSCLC, SCCHN, MSS-CRC, gastric/GEJ adenocarcinoma, cervical cancer (SCC or adenocarcinoma), RCC, UC, PDAC, melanoma, OC, or TNBC.
  • •- Parts 2A and 2B: NSCLC, SCCHN, gastric/GEJ adenocarcinoma, or up to 3 additional tumor types from Parts 1A and 1B may be considered based on emerging data.
  • •- Part 1C: NSCLC, SCCHN, gastric/GEJ adenocarcinoma, OC, or TNBC.
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1.2 Adults (18-64 years) yes
  • •F.1.2.1 Number of subjects for this age range 167
  • •F.1.3 Elderly (>=65 years) yes
  • •F.1.3.1 Number of subjects for this age range 110

Exclusion Criteria

  • •Women who are pregnant or breastfeeding
  • •Primary central nervous system (CNS) malignancy
  • •Untreated CNS metastases
  • •Leptomeningeal metastases
  • •Concurrent malignancy requiring treatment or history of prior malignancy active within 2 years prior to the first dose of study treatment
  • •Active, known, or suspected autoimmune disease
  • •Condition requiring systemic treatment with either corticosteroids within 14
  • •days or other immunosuppressive medications within 30 days of the first dose of study treatment
  • •Prior organ or tissue allograft
  • •Uncontrolled or significant cardiovascular disease
  • •Major surgery within 4 weeks of study drug administration
  • •History of or with active interstitial lung disease or pulmonary fibrosis
  • •Other protocol-defined inclusion/exclusion criteria apply

Investigators

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CA052002 is a Phase 1/2, multi-center,... | Clinical Trial