Early access
Sign in
Taking people in United StatesPhase 1/2

Tests BMS-986340 alone and combined in advanced solid tumors

Tests BMS-986340, alone or with other drugs, in adults with advanced solid tumors.

Key facts

Who runs it
Bristol-Myers Squibb
Where
Clovis, Hackensack, Houston, Iowa City, Los Angeles, Nashville, New York, Newport Beach, and Portland, United StatesSee the 11 sitesAlso in 7 other countries, 36 sites
Trial code
Registry title
A Study of BMS-986340 as Monotherapy and as Combination Therapy in Participants With Advanced Solid Tumors
Status
Recruiting
Phase
Phase 1/2
People taking part
1,109 people, planned
Started
27 May 2021
Expected to end
31 Aug 2031
Type of study
Interventional, 9 groups
Treatments tested
  • BMS-986340
  • BMS-936558-01
  • Docetaxel
  • Pumitamig
Record updated
17 August 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with advanced or metastatic solid tumors who have already had standard treatments and whose disease has gotten worse.

Age
18 years or older
Sex
Women and men can join.
Disease stage
Advanced or metastatic solid tumor with disease that can be measured on scans and has gotten worse on or after the latest treatment. ECOG performance status of 0 or 1.
Earlier treatment
People must have had standard treatments, including a PD-(L)1 inhibitor known to work for their tumor type, or cannot have them or cannot tolerate them. For some parts of the study (1C, 2C, 2D), people who had docetaxel for advanced or metastatic disease cannot join.
Biomarker or test result
A fresh tumor biopsy before treatment and another during treatment is required for biomarker testing. At least 1 tumor lesion must be reachable for biopsy.

Main reasons for not taking part

  • Pregnant or breastfeeding women
  • Cancer of the brain or spinal cord, untreated spread to the brain, or spread to the membranes around the brain
  • Another cancer needing treatment, or active within the last 2 years
  • Active, known or suspected autoimmune disease
  • Past organ or tissue transplant from a donor

The registry criteria, word for word

Show all 18 criteriaShow less

Who can take part

  • 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. Fine needle biopsy, cytology, and bone lesion biopsies are not acceptable
  • 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, (except for Part 1C, 2C and 2D, where participants with prior docetaxel use for the advanced/metastatic setting will be excluded), including an available programmed death (ligand)-1 inhibitor known to be effective in the tumor type for which they are being evaluated
  • Advanced or metastatic disease and have received, be refractory to, not be a candidate for, or be intolerant of existing therapies known to provide clinical benefit for the condition of the participant

Who cannot take part

  • 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
  • Major surgery within 4 weeks of study drug administration
  • Primary central nervous system (CNS) malignancy
  • 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
  • Uncontrolled or significant cardiovascular disease
  • History of or with active interstitial lung disease or pulmonary fibrosis
  • Women who are pregnant or breastfeeding
  • Untreated CNS metastases
  • Leptomeningeal metastases
  • Other protocol-defined inclusion/exclusion criteria apply

Where in United States

Also in 7 other countries, 36 sites

  • Community Cancer InstituteClovis, United StatesContact: Uzair Chaudhary, Site 0032Taking people
  • John Theurer Cancer CenterHackensack, United StatesContact: Martin Gutierrez, Site 0007Taking people
  • Houston Methodist HospitalHouston, United StatesContact: Maen Abdelrahim, Site 0061Taking people
  • University of IowaIowa City, United StatesContact: Douglas Laux, Site 0062Taking people
  • USC / Norris Comprehensive Cancer CenterLos Angeles, United StatesContact: Anthony El-Khoueiry, Site 0041Taking people
  • Vanderbilt University Medical CenterNashville, United StatesContact: Jordan Berlin, Site 0052Taking people
  • Nashville, TennesseeHospital not named in the registryNo longer taking part
  • New YorkHospital not named in the registryNo longer taking part
  • New YorkHospital not named in the registryNo longer taking part
  • Hoag Memorial Hospital PresbyterianNewport Beach, United StatesContact: Carlos Becerra, Site 0050Taking people
  • Providence Cancer Center Oncology and Hematology Care- EastsidePortland, United StatesContact: Rom Leidner, Site 0001Taking people

About the trial

What the trial wants to find out

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.

The 9 groups in the trial

  • Part 1A: BMS-986340 Dose EscalationTreatment being tested

    Treatment: BMS-986340

  • Part 2A: BMS-986340 Dose ExpansionTreatment being tested

    Treatment: BMS-986340

  • Part 1B: BMS-986340 + Nivolumab Dose EscalationTreatment being tested

    Treatment: BMS-986340 and BMS-936558-01

  • Part 2B: BMS-986340 + Nivolumab Dose ExpansionTreatment being tested

    Treatment: BMS-986340 and BMS-936558-01

  • Part 1C: BMS-986340 + Docetaxel Dose EscalationTreatment being tested

    Treatment: BMS-986340 and Docetaxel

  • Part 1A-J: BMS-986340 Dose EscalationTreatment being tested

    Treatment: BMS-986340

  • Part 1B-J: BMS-986340 + Nivolumab Dose EscalationTreatment being tested

    Treatment: BMS-986340 and BMS-936558-01

  • Part 2C: BMS-986340 + Docetaxel Dose ExpansionTreatment being tested

    Treatment: BMS-986340 and Docetaxel

  • Part 2D: BMS-986340 + Pumitamig Dose ExpansionTreatment being tested

    Treatment: BMS-986340 and Pumitamig

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
A Phase 1/2 Study of BMS-986340 as Monotherapy and as Combination Therapy in Participants With Advanced Solid Tumors
Plain-language title
Tests BMS-986340 alone and combined in advanced solid tumorsGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
17 August 2026