A Study of BMS-986340 as Monotherapy and as Combination Therapy in Participants With Advanced Solid Tumors
Recruiting
Phase 1Phase 2Interventional Study
Cervical CancerGastric/Gastroesophageal Junction AdenocarcinomaMicrosatellite Stable Colorectal CancerNon-Small-Cell Lung CancerSquamous Cell Carcinoma of Head and NeckCarcinoma, Renal CellUrothelial CarcinomaPancreatic AdenocarcinomaMelanomaOvarian NeoplasmsTriple Negative Breast Neoplasms
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 1/2
Study type
Interventional
Purpose
Treatment
Participants needed
1,109 (estimated)
Sponsor
Bristol-Myers Squibb · Industry
Who this trial is looking for
This trial is looking for people with advanced solid tumors to assess the safety and correct dose of a new drug called BMS-986340. Participants will need to provide tumor samples and have measurable disease.
Are You a Good Fit for This Trial?
You may be able to join if
I have measurable disease with at least one tumor that can be biopsied.
I have had progressive disease after my last treatment.
I have a performance status of 0 or 1.
I have received standard cancer therapies.
I have advanced or metastatic disease.
I can provide fresh tumor samples for testing.
You may not be able to join if
I am pregnant or breastfeeding.
I have a primary brain cancer.
I have untreated brain metastases.
I have an autoimmune disease.
I have had major surgery in the last 4 weeks.
I have a history of interstitial lung disease.
I have concurrent cancer that requires treatment.
I have had a prior organ transplant.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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.
Trial Locations
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Status
Eligibility Criteria
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. Fine needle biopsy, cytology, and bone lesion biopsies are…
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. 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 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.
Contacts
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
First line of the email MUST contain NCT # and Site #.
CONTACT
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