Clinical trial NCT06544655: A Study of BMS-986484 Alone and Combination Therapy in Participants With Advanced Solid Tumors
Official title: A Phase 1/1b First-in-human Trial of BMS-986484 as Monotherapy and Combination Therapy in Participants With Advanced Solid Malignancies
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Advanced Solid Tumors
Keywords: Opdivo®
Immunotherapy
BMS-986484
Non-small cell lung cancer (NSCLC)
Microsatellite stable (MSS) colorectal carcinoma (CRC)
Pancreatic ductal adenocarcinoma (PDAC)
Gastric/gastroesophageal junction adenocarcinoma (G/GEJC)
Squamous cell carcinoma of the head and neck (SCCHN)
anti-CD40
anti-FAP
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2024-08-09
Enrollment: 134
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief 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 criteria: Inclusion Criteria:

* 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 Criteria:

* 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.
* Other protocol-defined Inclusion/Exclusion criteria apply.

Primary outcomes:
measure: Incidence of adverse events (AEs)
timeFrame: Up to approximately 2 years
measure: Incidence of serious adverse events (SAEs)
timeFrame: Up to approximately 2 years
measure: Incidence of AEs meeting protocol defined dose-limiting toxicity (DLT) criteria
timeFrame: Up to approximately 28 days
measure: Incidence of AEs leading to discontinuation
timeFrame: Up to approximately 2 years
measure: Incidence of AEs leading to death
timeFrame: Up to approximately 2 years
Secondary outcomes:
measure: Maximum observed concentration (Cmax)
timeFrame: Up to approximately 2 years
measure: Time of maximum observed concentration (Tmax)
timeFrame: Up to approximately 2 years
measure: Area under the concentration-time curve (AUC)
timeFrame: Up to approximately 2 years
measure: Incidence of anti-drug antibodies (ADAs)
timeFrame: Up to approximately 2 years
measure: Objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)
timeFrame: Up to approximately 2 years
measure: Disease control rate (DCR) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)
timeFrame: Up to approximately 2 years
measure: Duration of response (DOR) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)
timeFrame: Up to approximately 2 years
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Local Institution - 0003
state: Arizona
city: Los Angeles
country: United States
facility: USC/Norris Comprehensive Cancer Center
state: California
city: Aurora
country: United States
facility: Local Institution - 0014
state: Colorado
city: Aurora
country: United States
facility: Local Institution - 0018
state: Colorado
city: Grand Rapids
country: United States
facility: START Midwest
state: Michigan
city: Sioux Falls
country: United States
facility: Sanford Cancer Center
state: South Dakota
city: San Antonio
country: United States
facility: NEXT Oncology
state: Texas
city: Darlinghurst
country: Australia
facility: St Vincent's Hospital
state: New South Wales
city: Elizabeth Vale
country: Australia
facility: Lyell McEwin Hospital
state: South Australia
city: Toronto
country: Canada
facility: Princess Margaret Cancer Centre
state: Ontario
city: Montréal
country: Canada
facility: Centre Hospitalier de l'Université de Montréal
state: Quebec
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: