A Study of BMS-986340 as Monotherapy and in Combination With Nivolumab or Docetaxel in Participants With Advanced Solid Tumors
Phase 1
Recruiting
- Conditions
- Gastric/Gastroesophageal Junction AdenocarcinomaCarcinoma, Renal CellCervical CancerNon-Small-Cell Lung CancerUrothelial CarcinomaOvarian NeoplasmsMicrosatellite Stable Colorectal CancerSquamous Cell Carcinoma of Head and NeckTriple Negative Breast NeoplasmsPancreatic Adenocarcinoma
- Interventions
- Registration Number
- NCT04895709
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 905
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Part 2B: BMS-986340 + Nivolumab Dose Expansion BMS-986340 - Part 1B: BMS-986340 + Nivolumab Dose Escalation BMS-936558-01 - Part 2B: BMS-986340 + Nivolumab Dose Expansion BMS-936558-01 - Part 1A: BMS-986340 Dose Escalation BMS-986340 - Part 1B: BMS-986340 + Nivolumab Dose Escalation BMS-986340 - Part 2A: BMS-986340 Dose Expansion BMS-986340 - Part 1C: BMS-986340 + Docetaxel Dose Escalation BMS-986340 - Part 1C: BMS-986340 + Docetaxel Dose Escalation Docetaxel -
- Primary Outcome Measures
Name Time Method Incidence of serious adverse events (SAEs) Up to 120 weeks Incidence of adverse events (AEs) Up to 120 weeks Incidence of AEs meeting protocol defined dose-limiting toxicity (DLT) criteria Up to 120 weeks Incidence of AEs leading to discontinuation Up to 120 weeks Incidence of AEs leading to death Up to 120 weeks
- Secondary Outcome Measures
Name Time Method PK parameters of BMS-986340 administered as monotherapy: Time to maximum concentration (Tmax) Up to 120 weeks PK parameters of BMS-986340 administered in combination with nivolumab: Maximum concentration (Cmax) Up to 120 weeks PK parameters of BMS-986340 administered in combination with docetaxel: Cmax Up to 120 weeks PK parameters of BMS-986340 administered in combination with docetaxel: Tmax Up to 120 weeks Incidence of anti-drug antibodies to BMS- 986340 when administered in combination with docetaxel Up to 120 weeks Objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by investigator At 6 months, 12 months Disease control rate (DCR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by investigator At 6 months, 12 months PK parameters of BMS-986340 administered in combination with nivolumab: Observed concentration at the end of the dosing interval (Ctau) Up to 120 weeks Pharmacokinetic (PK) parameters of BMS-986340 administered as monotherapy: Maximum concentration (Cmax) Up to 120 weeks PK parameters of BMS-986340 administered as monotherapy: Area under the concentration-time curve 1 dosing interval (AUC (TAU)) Up to 120 weeks PK parameters of BMS-986340 administered as monotherapy: Observed concentration at the end of the dosing interval (Ctau) Up to 120 weeks PK parameters of BMS-986340 administered in combination with nivolumab: Time to maximum concentration (Tmax) Up to 120 weeks PK parameters of BMS-986340 administered in combination with nivolumab: Area under the concentration-time curve in 1 dosing interval (AUC(TAU)) Up to 120 weeks PK parameters of BMS-986340 administered in combination with docetaxel: AUC(TAU) Up to 120 weeks PK parameters of BMS-986340 administered in combination with docetaxel: Ctau Up to 120 weeks Incidence of anti-drug antibodies to BMS- 986340 when administered as monotherapy Up to 120 weeks Incidence of anti-drug antibodies to BMS- 986340 when administered in combination with nivolumab Up to 120 weeks Duration of response (DOR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by investigator At 6 months, 12 months Progression-free survival rate (PFSR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by investigator At 6 months, 12 months
Trial Locations
- Locations (47)
Universitaetsklinikum Essen
🇩🇪Essen, Germany
Community Cancer Institute
🇺🇸Clovis, California, United States
USC/Norris Comprehensive Cancer Center
🇺🇸Los Angeles, California, United States
Hoag Memorial Hospital Presbyterian
🇺🇸Newport Beach, California, United States
University of Iowa
🇺🇸Iowa City, Iowa, United States
John Theurer Cancer Center
🇺🇸Hackensack, New Jersey, United States
Columbia University Irving Medical Center
🇺🇸New York, New York, United States
Local Institution - 0002
🇺🇸New York, New York, United States
Providence Cancer Center Oncology and Hematology Care- Eastside
🇺🇸Portland, Oregon, United States
Local Institution - 0063
🇺🇸Nashville, Tennessee, United States
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