A Phase 1/1b First-in-human Trial of BMS-986484 as Monotherapy and Combination Therapy in Participants With Advanced Solid Malignancies

Status: Recruiting
Location: See all (9) locations...
Intervention Type: Biological, Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

The purpose of this study is to assess the safety and tolerability of BMS-986484 administered alone, in combination with nivolumab in participants with advanced/metastatic solid tumors including non-small cell lung cancer (NSCLC), microsatellite stable (MSS) colorectal carcinoma (CRC), pancreatic ductal adenocarcinoma (PDAC), gastric/gastroesophageal junction adenocarcinoma (G/GEJC), and squamous cell carcinoma of the head and neck (SCCHN).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Locally advanced unresectable, metastatic, or recurrent malignant tumors including non-small cell lung cancer (NSCLC), pancreatic ductal adenocarcinoma (PDAC), gastric/gastroesophageal junction adenocarcinoma (G/GEJC), microsatellite stable colorectal cancer (MSS CRC), and squamous cell carcinoma of the head and neck (SCCHN).

• Must have measurable disease by response evaluation criteria in solid tumors version 1.1 (RECIST v1.1).

• Must have an Eastern Cooperative Oncology Group Performance Status of 0 or 1.

Locations
United States
Arizona
University of Arizona Cancer Center
RECRUITING
Tucson
California
USC/Norris Comprehensive Cancer Center
RECRUITING
Los Angeles
Michigan
START Midwest
RECRUITING
Grand Rapids
South Dakota
Sanford Cancer Center
RECRUITING
Sioux Falls
Texas
NEXT Oncology
RECRUITING
San Antonio
Other Locations
Australia
St Vincent's Hospital
RECRUITING
Darlinghurst
Lyell McEwin Hospital
RECRUITING
Elizabeth Vale
Canada
Centre Hospitalier de l'Université de Montréal
RECRUITING
Montreal
Princess Margaret Cancer Centre
RECRUITING
Toronto
Contact Information
Primary
BMS Study Connect Contact Center www.BMSStudyConnect.com
Clinical.Trials@bms.com
855-907-3286
Backup
First line of the email MUST contain NCT # and Site #.
Time Frame
Start Date: 2024-10-10
Estimated Completion Date: 2027-10-14
Participants
Target number of participants: 213
Treatments
Experimental: Part 1A: BMS-986484 Dose Escalation
Experimental: Part 1B: BMS-986484 + Nivolumab Dose Escalation
Experimental: Part 2A: BMS-986484 Dose Expansion
Experimental: Part 2B: BMS-986484 + Nivolumab Dose Expansion
Experimental: Part 1C: BMS-986484 + Nivolumab + Chemotherapy Dose Escalation
Experimental: Part 1 Co-Admin: BMS-986484 + Nivolumab
Experimental: Part 1SC: BMS-986484 Monotherapy Subcutaneous Dose Escalation
Experimental: Part 2C: BMS-986484 + Nivolumab + Chemotherapy Dose Expansion
Sponsors
Leads: Bristol-Myers Squibb

This content was sourced from clinicaltrials.gov