Clinical trial NCT06697197: A Study of BMS-986482 Alone or as Combination Therapy in Participants With Advanced Solid Tumors
Official title: A Phase 1/2 Study of BMS-986482 as Monotherapy or Combination Therapy in Participants With Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Advanced Solid Tumors
Keywords: Immuno-oncology
Regulatory T cells
Tregs
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2024-11-20
Enrollment: 413
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to test the safety and efficacy of BMS-986482 alone and as combination therapy in participants with advanced solid tumors.


Eligibility criteria: Inclusion Criteria:

* All participants must have a histologically or cytologically confirmed, advanced, unresectable/metastatic, solid malignancy measurable by RECIST v1.1, and have received, be refractory to, ineligible for, intolerant of, or refused existing therapy(ies) known to provide clinical benefit for the condition of the participant.
* Participant must be ≥ 18 years or the legal age of consent in the jurisdiction in which the study is taking place, inclusive, at the time of signing the ICF.
* Participants in Part 1A may have NSCLC, SCCHN, MSS-CRC, gastric/GEJ adenocarcinoma, urothelial carcinoma, PDAC, melanoma or breast cancer (TNBC and ER+HER2-).
* Participants in Part 1B1 and 2B1 must have NSCLC and, if known, should have documented status for EGFR, KRAS, ALK, ROS1, RET, NTRK, MET exon 14 skipping mutations, and BRAF V600E.Participants must have received platinum-based chemotherapy and anti-PD-(L)1 therapy, if eligible and available.
* Participants in Parts 1B2, 2B2, and 1C must have cutaneous, acral, mucosal, or unknown primary melanoma. Participants with uveal/ocular melanoma are excluded. Participants must be melanoma 2L+.
* Participants in Part 1B3 must have advanced or metastatic MSS-CRC.
* Participants in Part 2A may have advanced solid tumors (advanced, unresectable, or metastatic NSCLC, advanced, unresectable, hormone resistant ER+HER2-breast cancer or pancreatic adenocarcinoma \[PDAC\]) based on emerging data.
* Participants in Part 2B3 must have advanced or metastatic MSS-CRC.
* For all participants in Part 1C cohort, a tumor sample from a ("fresh") biopsy \[core biopsy (at least 4 passages recommended), punch biopsy, excisional biopsy or surgical specimen\] must be obtained (obtained within 1 month of the start of the Screening, if there are tumor sites that can be biopsied with acceptable clinical risk).

Exclusion Criteria:

* History of life threatening immune mediated toxicity related to prior T-cell agonist or checkpoint inhibitor therapy, except those that are unlikely to re-occur with standard countermeasures.
* Any significant acute or chronic medical illness which would interfere with study intervention or follow-up in the opinion of the investigator.
* Other protocol-defined Inclusion/Exclusion criteria apply.

Primary outcomes:
measure: Number of participants with Adverse Events (AEs) as assessed by National Cancer Institute -Common Terminology Criteria for Adverse Events version 5.0 (NCI-CTCAE v5.0)
timeFrame: Up to 135 days post last treatment visit
measure: Number of participants with Serious AEs (SAEs) as assessed by NCI-CTCAE v5.0
timeFrame: Up to 135 days post last treatment visit
measure: Number of participants with AEs meeting protocol-defined Dose-Limiting Toxicity (DLT) criteria as assessed by NCI-CTCAE v5.0
timeFrame: Up to Day 28
measure: Number of participants with AEs leading to discontinuation as assessed by NCI-CTCAE v5.0
timeFrame: Up to 135 days post last treatment visit
measure: Number of deaths as assessed by NCI-CTCAE v5.0
timeFrame: Through study completion (approximately 5 years)
Secondary outcomes:
measure: Concentration at the end of infusion (Cmax)
timeFrame: Up to 135 days post last treatment visit
measure: Time of maximum observed concentration (Tmax)
timeFrame: Up to 135 days post last treatment visit
measure: Area under the concentration-time curve in one dosing interval (AUC(TAU))
timeFrame: Up to 135 days post last treatment visit
measure: Overall Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST v1.1) as assessed by Investigator
timeFrame: Up to 135 days post last treatment visit
Other outcomes:
Locations:
city: Irvine
country: United States
facility: Local Institution - 0005
state: California
city: Los Angeles
country: United States
facility: Local Institution - 0030
state: California
city: Aurora
country: United States
facility: Local Institution - 0008
state: Colorado
city: Hackensack
country: United States
facility: John Theurer Cancer Center at Hackensack University Medical Center
state: New Jersey
city: Lake Success
country: United States
facility: Northwell Health/ RJ Zuckerberg Cancer Center
state: New York
city: Charlotte
country: United States
facility: Local Institution - 0011
state: North Carolina
city: Seattle
country: United States
facility: Fred Hutchinson Cancer Center
state: Washington
city: Gent
country: Belgium
facility: Local Institution - 0017
state: Oost-Vlaanderen
city: Copenhagen
country: Denmark
facility: Local Institution - 0022
state: Hovedstaden
city: Marseille
country: France
facility: Local Institution - 0016
state: Bouches-du-Rhône
city: Villejuif
country: France
facility: Local Institution - 0012
state: Val-de-Marne
city: Athens
country: Greece
facility: Local Institution - 0038
state: Attikí
city: Thessaloniki
country: Greece
facility: Local Institution - 0039
state: Thessaloníki
city: Milan
country: Italy
facility: Local Institution - 0037
state: Lombardia
city: Rozzano
country: Italy
facility: Local Institution - 0036
state: Milano
city: Amsterdam
country: Netherlands
facility: Local Institution - 0018
state: Noord-Holland
city: Rotterdam
country: Netherlands
facility: Local Institution - 0028
city: Barcelona
country: Spain
facility: Local Institution - 0033
state: Barcelona [Barcelona]
city: Pamplona
country: Spain
facility: Local Institution - 0035
state: Navarra
city: Madrid
country: Spain
facility: Local Institution - 0034
city: Solna
country: Sweden
facility: Local Institution - 0023
state: Stockholms Län [se-01]
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: