Clinical trial NCT06764771: A Study of BMS-986488 as Monotherapy and Combination Therapy in Participants With Advanced Malignant Tumors
Official title: A Phase 1/1b Open-label Study of BMS-986488 as Monotherapy and Combination Therapy in Participants With Advanced Malignant Tumors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Advanced Malignant Tumors
Keywords: Colorectal Cancer
CRC
Renal Cell Carcinoma
RCC
Non-Small Cell Lung Cancer
NSCLC
Cancer
Oncology
Phase 1
Solid Tumor
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2025-01-08
Enrollment: 437
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: This purpose of this study is to determine if experimental treatment with BMS-986488, alone, or in combinations is safe, tolerable, and has anti-cancer activity in patients with advanced malignant tumors.


Eligibility criteria: Inclusion Criteria:

* Participant must be ≥ 18 years of age.
* Histologically confirmed diagnosis of a locally advanced and unresectable or metastatic solid tumor malignancy with any of the following tumor types:.
* Part 1A: clear-cell renal cell carcinoma (ccRCC), clear-cell ovarian cancer (ccOC), non-small cell lung cancer (NSCLC), colorectal cancer (CRC), and pancreatic ductal adenocarcinoma (PDAC).
* Parts 2A, 1D, 2D: ccRCC.

  i) Part 1B: solid tumors with KRAS G12C mutation.

ii) Part 2B: NSCLC with KRAS G12C mutation.

iii) Parts 1C, 2C: colorectal cancer (CRC) with KRAS G12C mutation.

* Participants must have an Eastern Cooperative Oncology Groups (ECOG) Performance Status of 0 or 1.
* Participants must have measurable disease per RECIST v1.1.

Exclusion Criteria:

* Untreated central nervous system (CNS) metastases.
* Leptomeningeal metastasis (carcinomatous meningitis).
* Impaired cardiac function or clinically significant cardiac disease.
* For Parts 1B, 1C, 2B, 2C only (combination with adagrasib):.

  i) History of pneumonitis or interstitial lung disease (ILD).

ii) History of prior severe cutaneous adverse reactions (SCARs), including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN).

- Other protocol-defined inclusion/exclusion criteria apply.

Primary outcomes:
measure: Number of participants with Adverse Events (AEs)
timeFrame: Until the end of the Safety Follow-up period (up to approximately 100 days after last dose)
measure: Number of participants with Serious AEs (SAEs)
timeFrame: Until the end of the Safety Follow-up period (up to approximately 100 days after last dose)
measure: Number of participants with AEs meeting protocol-defined Dose-Limiting Toxicity (DLT) criteria
timeFrame: From first dose of study treatment until end of cycle 1 (1 Cycle = 28 Days)
measure: Number of participants with AEs leading to discontinuation
timeFrame: Until the end of the Safety Follow-up period (up to approximately 100 days after last dose)
measure: Number of deaths
timeFrame: From time of informed consent up to 52 weeks after end of treatment visit
Secondary outcomes:
measure: Maximum observed plasma concentration (Cmax)
timeFrame: Until Cycle 4, Day 1 (1 Cycle = 28 Days)
measure: Time of maximum observed concentration (Tmax)
timeFrame: Until Cycle 4, Day 1 (1 Cycle = 28 Days)
measure: Area under the concentration-time curve in 1 dosing interval (AUC(TAU))
timeFrame: Until Cycle 4, Day 1 (1 Cycle = 28 Days)
measure: Objective response rate (ORR)
timeFrame: From time of informed consent up to 52 weeks after end of treatment visit
measure: Disease control rate (DCR)
timeFrame: From time of informed consent up to 52 weeks after end of treatment visit
measure: Duration of response (DOR)
timeFrame: From time of informed consent up to 52 weeks after end of treatment visit
Other outcomes:
Locations:
city: Hackensack
country: United States
facility: John Theurer Cancer Center at Hackensack University Medical Center
state: New Jersey
city: Allentown
country: United States
facility: Local Institution - 0020
state: Pennsylvania
city: Germantown
country: United States
facility: The West Clinic, PLLC dba West Cancer Center
state: Tennessee
city: Dallas
country: United States
facility: Local Institution - 0025
state: Texas
city: Brisbane
country: Australia
facility: Local Institution - 0031
state: Queensland
city: Vancouver
country: Canada
facility: BC Cancer Vancouver
state: British Columbia
city: Montréal
country: Canada
facility: Local Institution - 0015
state: Quebec
city: Quebec City
country: Canada
facility: Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus
state: Quebec
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: