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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06764771




Registration number
NCT06764771
Ethics application status
Date submitted
3/01/2025
Date registered
8/01/2025
Date last updated
8/01/2025

Titles & IDs
Public title
A Study of BMS-986488 as Monotherapy and Combination Therapy in Participants With Advanced Malignant Tumors
Scientific title
A Phase 1/1b Open-label Study of BMS-986488 as Monotherapy and Combination Therapy in Participants With Advanced Malignant Tumors
Secondary ID [1] 0 0
CA234-0001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced Malignant Tumors 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - BMS-986488
Treatment: Drugs - Adagrasib
Treatment: Drugs - Cetuximab
Treatment: Drugs - Nivolumab

Experimental: Part 1A: BMS-986488 Monotherapy -

Experimental: Part 1B: BMS-986488 + Adagrasib -

Experimental: Part 1C: BMS-986488 + Adagrasib + Cetuximab -

Experimental: Part 1D: BMS-986488 + Nivolumab -

Experimental: Part 2A: BMS-986488 Monotherapy -

Experimental: Part 2B: BMS-986488 + Adagrasib -

Experimental: Part 2C: BMS-986488 + Adagrasib + Cetuximab -

Experimental: Part 2D: BMS-986488 + Nivolumab -


Treatment: Drugs: BMS-986488
Specified dose on specified days

Treatment: Drugs: Adagrasib
Specified dose on specified days

Treatment: Drugs: Cetuximab
Specified dose on specified days

Treatment: Drugs: Nivolumab
Specified dose on specified days
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of participants with Adverse Events (AEs)
Timepoint [1] 0 0
Until the end of the Safety Follow-up period (up to approximately 100 days after last dose)
Primary outcome [2] 0 0
Number of participants with Serious AEs (SAEs)
Timepoint [2] 0 0
Until the end of the Safety Follow-up period (up to approximately 100 days after last dose)
Primary outcome [3] 0 0
Number of participants with AEs meeting protocol-defined Dose-Limiting Toxicity (DLT) criteria
Timepoint [3] 0 0
From first dose of study treatment until end of cycle 1 (1 Cycle = 28 Days)
Primary outcome [4] 0 0
Number of participants with AEs leading to discontinuation
Timepoint [4] 0 0
Until the end of the Safety Follow-up period (up to approximately 100 days after last dose)
Primary outcome [5] 0 0
Number of deaths
Timepoint [5] 0 0
From time of informed consent up to 52 weeks after end of treatment visit
Secondary outcome [1] 0 0
Maximum observed plasma concentration (Cmax)
Timepoint [1] 0 0
Until Cycle 4, Day 1 (1 Cycle = 28 Days)
Secondary outcome [2] 0 0
Time of maximum observed concentration (Tmax)
Timepoint [2] 0 0
Until Cycle 4, Day 1 (1 Cycle = 28 Days)
Secondary outcome [3] 0 0
Area under the concentration-time curve in 1 dosing interval (AUC(TAU))
Timepoint [3] 0 0
Until Cycle 4, Day 1 (1 Cycle = 28 Days)
Secondary outcome [4] 0 0
Objective response rate (ORR)
Timepoint [4] 0 0
From time of informed consent up to 52 weeks after end of treatment visit
Secondary outcome [5] 0 0
Disease control rate (DCR)
Timepoint [5] 0 0
From time of informed consent up to 52 weeks after end of treatment visit
Secondary outcome [6] 0 0
Duration of response (DOR)
Timepoint [6] 0 0
From time of informed consent up to 52 weeks after end of treatment visit

Eligibility
Key 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) or clear-cell ovarian cancer (ccOC).
* 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
28/02/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
15/10/2027
Actual
Sample size
Target
437
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
Local Institution - 0031 - Brisbane
Recruitment postcode(s) [1] 0 0
4029 - Brisbane
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
New Jersey
Country [2] 0 0
United States of America
State/province [2] 0 0
Pennsylvania
Country [3] 0 0
United States of America
State/province [3] 0 0
Tennessee
Country [4] 0 0
United States of America
State/province [4] 0 0
Texas
Country [5] 0 0
Canada
State/province [5] 0 0
British Columbia
Country [6] 0 0
Canada
State/province [6] 0 0
Quebec

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Bristol-Myers Squibb
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT06764771
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bristol-Myers Squibb
Address 0 0
Bristol-Myers Squibb
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
Address 0 0
Country 0 0
Phone 0 0
8559073286
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06764771