A Study of BMS-986340 as Monotherapy and as Combination Therapy in Participants With Advanced Solid Tumors

Part of paid clinical trials in Clovis, California.

Sponsor
Bristol-Myers Squibb
Study ID
NCT04895709
Phase
PHASE1/PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • BMS-986340 — DRUG
    Specified dose on specified days
  • BMS-936558-01 — DRUG
    Specified dose on specified days
  • Docetaxel — DRUG
    Specified dose on specified days
  • Pumitamig — DRUG
    Specified dose on specified days

Study Details

The purpose of this study is to assess the safety, tolerability, and recommended dose(s) of BMS-986340 as monotherapy and in combination with nivolumab, docetaxel, or Pumitamig in participants with advanced solid tumors. This study is a first-in-human (FIH) study of BMS-986340 in participants with advanced solid tumors.

Key Dates

Start date
May 27, 2021
Status verified
Jun 2026
Primary completion
Aug 31, 2031
Completion
Aug 31, 2031

Study Design

Enrollment
1,109 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Part 1A: BMS-986340 Dose Escalation
  • Experimental: Part 2A: BMS-986340 Dose Expansion
  • Experimental: Part 1B: BMS-986340 + Nivolumab Dose Escalation
  • Experimental: Part 2B: BMS-986340 + Nivolumab Dose Expansion
  • Experimental: Part 1C: BMS-986340 + Docetaxel Dose Escalation
  • Experimental: Part 1A-J: BMS-986340 Dose Escalation
  • Experimental: Part 1B-J: BMS-986340 + Nivolumab Dose Escalation
  • Experimental: Part 2C: BMS-986340 + Docetaxel Dose Expansion
  • Experimental: Part 2D: BMS-986340 + Pumitamig Dose Expansion

Primary Outcome Measure

Incidence of adverse events (AEs) [ Time Frame: Up to 120 weeks ]

Central Contacts

  • BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
    855-907-3286
    [email protected]
  • First line of the email MUST contain NCT # and Site #.

Locations (11)

FacilityCityStateZIPSite coordinators
Community Cancer InstituteClovisCalifornia93611
Uzair Chaudhary, Site 0032
559-387-1600
USC/Norris Comprehensive Cancer CenterLos AngelesCalifornia90033
Anthony El-Khoueiry, Site 0041
323-865-3967
Hoag Memorial Hospital PresbyterianNewport BeachCalifornia92663
Carlos Becerra, Site 0050
949-764-8222
University of IowaIowa CityIowa52242
Douglas Laux, Site 0062
319-356-1032
John Theurer Cancer CenterHackensackNew Jersey07601
Martin Gutierrez, Site 0007
551-996-5863
Local Institution - 0002New YorkNew York10065-
Local Institution - 0006New YorkNew York10032-
Providence Cancer Center Oncology and Hematology Care- EastsidePortlandOregon97213
Rom Leidner, Site 0001
503-215-5696
Local Institution - 0063NashvilleTennessee37067
Site 0063
Vanderbilt University Medical CenterNashvilleTennessee37232
Jordan Berlin, Site 0052
615-936-1796
Houston Methodist HospitalHoustonTexas77030
Maen Abdelrahim, Site 0061
346-241-5495

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