A Phase 1/2 Study of BMS-986340 with and without Nivolumab or Docetaxel in Solid Tumors

Phase 1/2

Recruiting

• Conditions: Male and female participants ≥ 18 years of age with advanced or metastatic cancers

• Registration Number: 2023-503651-10-00
• Lead Sponsor: Bristol-Myers Squibb Services Unlimited Company

Brief Summary

To assess the safety, tolerability, and to determine the MTD, MAD,

and/or RP2D(s) of BMS-986340 administered as monotherapy and in

combination with nivolumab or docetaxel

Detailed Description

Not available

Study Timeline

• Study First Posted: 2023-08-11
• Last Update Posted: 2025-06-09

Recruitment & Eligibility

• Status: Ongoing, recruiting
• Sex: Not specified
• Target Recruitment: 163

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

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, including an available programmed death (ligand)-1 inhibitor known to be effective in the tumor type for which they are being evaluated (except for Part 1C, where participants with prior docetaxel use for the advanced/metastatic setting will be excluded)

Participants must have advanced or metastatic disease, and have received, be refractory to, not be a candidate for, or be intolerant to existing therapies known to provide clinical benefit for the condition of the participant. Eligible tumor types for each Part are listed below: - Parts 1A and 1B: NSCLC, SCCHN, MSS-CRC, gastric/GEJ adenocarcinoma, cervical cancer (SCC or adenocarcinoma), RCC, UC, PDAC, melanoma, OC, or TNBC. - Parts 2A and 2B: NSCLC, SCCHN, gastric/GEJ adenocarcinoma, or up to 3 additional tumor types from Parts 1A and 1B may be considered based on emerging data. - Part 1C: NSCLC, SCCHN, gastric/GEJ adenocarcinoma, OC, or TNBC. Other protocol-defined inclusion criteria apply.

Exclusion Criteria

Women who are pregnant or breastfeeding

Major surgery within 4 weeks of study drug administration

History of or with active interstitial lung disease or pulmonary fibrosis Other protocol-defined exclusion criteria apply

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

Study & Design

• Study Type: Not specified
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of AEs, SAEs, AEs meeting protocol defined DLT criteria, AEs leading to discontinuation and death		Incidence of AEs, SAEs, AEs meeting protocol defined DLT criteria, AEs leading to discontinuation and death

Secondary Outcome Measures

Name	Time	Method
Summary measures of PK parameters of BMS-986340 administered as monotherapy and in combination with nivolumab or docetaxel		Summary measures of PK parameters of BMS-986340 administered as monotherapy and in combination with nivolumab or docetaxel
Incidence of anti-drug antibodies to BMS-986340 when BMS-986340 is administered as monotherapy and in combination with nivolumab or docetaxel		Incidence of anti-drug antibodies to BMS-986340 when BMS-986340 is administered as monotherapy and in combination with nivolumab or docetaxel
ORR, DCR, DOR, and PFSR		ORR, DCR, DOR, and PFSR

Trial Locations

Locations (17)

Hospital Universitari Germans Trias I Pujol; 🇪🇸 Badalona, Spain

Clinica Universidad De Navarra; 🇪🇸 Madrid, Spain

Hospital Universitario Hm Sanchinarro; 🇪🇸 Madrid, Spain

Hospital Universitario 12 De Octubre; 🇪🇸 Madrid, Spain

Hospital Universitario Virgen De La Victoria; 🇪🇸 Malaga, Spain

Hospital Universitario Fundacion Jimenez Diaz; 🇪🇸 Madrid, Spain

Vall D'hebron Institut De Recerca; 🇪🇸 Barcelona, Spain

Goethe University Frankfurt; 🇩🇪 Frankfurt Am Main, Germany

Universitaetsklinikum Ulm AöR; 🇩🇪 Ulm, Germany

Universitaetsklinikum Wuerzburg AöR; 🇩🇪 Wuerzburg, Germany

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Hospital Universitari Germans Trias I Pujol

🇪🇸Badalona, Spain

Cinta Hierro Carbo

Site contact

+34934978925

chierro@iconcologia.net