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Study of BMS-986340 for Advanced Solid Tumors

This study is testing a new drug called BMS-986340, either by itself or with other drugs like BMS-936558-01, Docetaxel, or Pumitamig. It's for people aged 18 and older with advanced solid tumors, including cervical, gastric, colorectal, non-small cell lung, and head and neck cancers. The main goal is to find out how safe these treatments are and what the best dose is. To join, you need to have cancer that can be measured and a tumor that can be biopsied. You'll also need to provide fresh tumor samples for analysis. This is the first time BMS-986340 is being tested in humans.

Study design
This is an interventional study planning to enroll 1109 participants. It is testing different drugs and combinations.
What's involved
You would need to provide fresh tumor biopsies before and during treatment. You must also have measurable disease and a tumor accessible for biopsy.
Compensation
Not stated in the trial record.
Follow-up
Your health will be monitored for side effects for up to 120 weeks.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04895709

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
Bristol-Myers Squibb
~1,109 participants
Updated 2026-08-17 on ClinicalTrials.gov
What's tested:BMS-986340BMS-936558-01DocetaxelPumitamig

At a glance

Recruiting sites
39 of 47 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of adverse events (AEs)
Measured over Up to 120 weeks
+4 more outcomes measured

Conditions

Cervical Cancer
Gastric/Gastroesophageal Junction Adenocarcinoma
Microsatellite Stable Colorectal Cancer
Non-Small-Cell Lung Cancer
Squamous Cell Carcinoma of Head and Neck
Carcinoma, Renal Cell
Urothelial Carcinoma
Pancreatic Adenocarcinoma
Melanoma
Ovarian Neoplasms
Triple Negative Breast Neoplasms

Explore related trials

Breast CarcinomaCervical CarcinomaColorectal CarcinomaGastric AdenocarcinomaGastroesophageal Junction AdenocarcinomaHead and Neck Squamous Cell CarcinomaLung Non-Small Cell CarcinomaMelanomaOvarian NeoplasmPancreatic AdenocarcinomaRenal Cell CarcinomaSolid NeoplasmUrothelial CarcinomaMSI-MMRProgrammed Cell Death 1 Ligand 1Programmed Cell Death Protein 1

Where it's being run

47 sites across 29 states
Germany4
Italy4
California3
Central District3
Spain3
New York2
Tennessee2
New South Wales2

Study leadership

  • Bristol-Myers Squibb · STUDY_DIRECTOR · Bristol-Myers Squibb

Who to contact

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
[email protected]
855-907-3286
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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.

Exclusion

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.

What this trial measures

  • Incidence of adverse events (AEs)Up to 120 weeks
  • Incidence of serious adverse events (SAEs)Up to 120 weeks
  • Incidence of AEs meeting protocol defined dose-limiting toxicity (DLT) criteriaUp to either 21 or 28 days
  • Incidence of AEs leading to discontinuationUp to 120 weeks
  • Number of deathsUp to 120 weeks