RecruitingPhase 1NCT06544655

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


Sponsor

Bristol-Myers Squibb

Enrollment

213 participants

Start Date

Oct 10, 2024

Study Type

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

Min Age: 18 Years

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

DRUGBMS-986484

Specified dose on specified days

BIOLOGICALNivolumab

Specified dose on specified days

DRUGOxaliplatin

Specified dose on specified days

DRUGCapecitabine

Specified dose on specified days

DRUGFluorouracil

Specified dose on specified days

DRUGCalcium folinate

Specified dose on specified days


Locations(11)

University of Arizona Cancer Center

Tucson, Arizona, United States

USC/Norris Comprehensive Cancer Center

Los Angeles, California, United States

START Midwest

Grand Rapids, Michigan, United States

Sanford Cancer Center

Sioux Falls, South Dakota, United States

NEXT Oncology

San Antonio, Texas, United States

St Vincent's Hospital

Darlinghurst, New South Wales, Australia

Lyell McEwin Hospital

Elizabeth Vale, South Australia, Australia

Princess Margaret Cancer Centre

Toronto, Ontario, Canada

Centre Hospitalier de l'Université de Montréal

Montreal, Quebec, Canada

Local Institution - 0023

Chuo-ku, Tokyo, Japan

Local Institution - 0022

Kashiwa, Japan

View Full Details on ClinicalTrials.gov

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NCT06544655


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