Share Icon Health Study Area: Cardiovascular Disease Chevron Icon Health Study Area: Genitourinary For Patients Health Study Area: Lung Cancer Page Icon Phone Icon For Caregivers Health Study Area: AutoImmune Disease Health Study Area: Melanoma Location Icon Print YouTube Icon For Parents Health Study Area: Lung Cancer Print Created with Sketch. Help Icon Green Check Icon Search Icon Instagram Created with sketchtool. Direction Arrow Icon Error Icon For Parents Health Study Area: Blood Cancer Help Icon Health Study Area: NASH Gender Both Bookmark Icon Health Study Area: Melanoma Created with Sketch. Glossary Print Health Study Area: Blood Cancer Health Study Area: Genitourinary Health Study Area: Gastrointestinal Cancer Mobile Menu Icon Created with Sketch. Health Study Area: Cardiovascular Disease Health Study Area: Women's Cancer Communities Map Icon Created with Sketch. For Caregivers Health Study Area: Fibrosis Health Study Area: AutoImmune Disease FAQs Health Study Area: Head and Neck Cancer Created with Sketch. For Clinicians Chevron Right Icon Gender Female Health Study Area: Breast Cancer Direction Arrow Icon Gender Both Right Arrow Icon LinkedIn Icon Green Check Icon Gender Male Health Study Area: Fibrosis For Patients Twitter Icon Email Icon Facebook Icon Health Study Area: Gastrointestinal Cancer Health Study Area: Head and Neck Cancer For Clinicians External Link Icon
BMS Recruiting Study icon

Recruiting

Trial ID CA052-002  |   NCT04895709

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

Summary

  • Phase 1/Phase 2
  • Male and Female Gender icon
  • 18+
    Age Range
  • 41
    Locations
  • BMS Recruiting Study icon
    Recruiting

Overview

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 or docetaxel in participants with advanced solid tumors. This study is a first-in-human (FIH) study of BMS-986340 in participants with advanced solid tumors.

Nearest Recruiting Site

Key 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, 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

Treatment Options

Study Arms

ASSIGNED INTERVENTION

Study Arms

Experimental: Part 1A: BMS-986340 Dose Escalation

ASSIGNED INTERVENTION
  • Drug: BMS-986340

Study Arms

Experimental: Part 1B: BMS-986340 + Nivolumab Dose Escalation

ASSIGNED INTERVENTION
  • Drug: BMS-986340, BMS-936558-01

Study Arms

Experimental: Part 1C: BMS-986340 + Docetaxel Dose Escalation

ASSIGNED INTERVENTION
  • Drug: Docetaxel, BMS-986340

Study Arms

Experimental: Part 2A: BMS-986340 Dose Expansion

ASSIGNED INTERVENTION
  • Drug: BMS-986340

Study Arms

Experimental: Part 2B: BMS-986340 + Nivolumab Dose Expansion

ASSIGNED INTERVENTION
  • Drug: BMS-936558-01, BMS-986340
Please select a study site to register
Select a Study Site Location
Select a study site location that is convenient for you
Register
Provide your contact details for the study site to connect with you.