A Study of BMS-986484 Alone and Combination Therapy in Participants With Advanced Solid Tumors
A Phase 1/1b First-in-human Trial of BMS-986484 as Monotherapy and Combination Therapy in Participants With Advanced Solid Malignancies
Bristol-Myers Squibb
213 participants
Oct 10, 2024
INTERVENTIONAL
Conditions
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
Inclusion Criteria3
- 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.
Exclusion Criteria4
- History of or with active interstitial lung disease or pulmonary fibrosis.
- Active, known, or suspected autoimmune disease.
- Serious uncontrolled medical disorders.
- New onset, non-catheter-associated venous thromboembolism within the past 6 months.
Interventions
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
Locations(11)
View Full Details on ClinicalTrials.gov
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NCT06544655