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RecruitingPhase 1 / Phase 2

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

A Phase 1/2 Study of BMS-986340 as Monotherapy and as Combination Therapy in Participants With Advanced Solid Tumors

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests BMS-986340 alone or with nivolumab, docetaxel, or Pumitamig in people with advanced solid tumors. It looks at safety, side effects, and which doses to use. This is the first study of BMS-986340 in humans.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have advanced cancer or cancer that has spread. You must have tried standard treatments, or available treatments must not work for you or be suitable for you.
  • Have received standard cancer treatments, including an available PD-1 or PD-L1 inhibitor (a type of immune treatment) known to work for your cancer type.
  • Have scans showing that your cancer grew or spread during or after your most recent treatment.
  • Have cancer that can be measured using the study’s rules, with at least one tumor that can be sampled.
  • Provide new tumor tissue samples before and during treatment. Fine-needle samples, cell-only samples, and samples from bone tumors do not count.
  • Be fully active or able to do light work, even if you cannot do hard physical activity.
  • For Parts 1C, 2C, and 2D, you must not have received docetaxel for advanced cancer or cancer that has spread.

Who can't join

  • Are pregnant or breastfeeding.
  • Have cancer that started in the brain or spinal cord, untreated cancer spread there, or cancer spread to the lining around them.
  • Have another cancer that needs treatment, or a past cancer that was active within 2 years before the first study dose.
  • Have a known or suspected active autoimmune disease (when the immune system attacks the body), or need whole-body steroid treatment within 14 days or other immune-suppressing drugs within 30 days before the first study dose.
  • Have received an organ or tissue transplant from another person.
  • Have uncontrolled or serious heart or blood vessel disease.
  • Have had major surgery within 4 weeks before receiving the study drug.
  • Have or have had interstitial lung disease or pulmonary fibrosis (lung damage or scarring).

Simplified for readability. The official criteria below are what the study team uses.

Official 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 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.

Study sites (11)

CA

IA

NJ

NY

OR

TN

TX