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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06730750




Registration number
NCT06730750
Ethics application status
Date submitted
9/12/2024
Date registered
12/12/2024
Date last updated
29/05/2025

Titles & IDs
Public title
A Study of BMS-986490 With or Without Bevacizumab in Advanced Solid Tumors
Scientific title
A Phase 1/2a, Multicenter, Open-label, First in Human Study of BMS-986490 With or Without Bevacizumab in Advanced Solid Tumors
Secondary ID [1] 0 0
CA238-0001
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - BMS-986490
Treatment: Drugs - Bevacizumab

Experimental: Part 1A -

Experimental: Part 2A - Colorectal Cancer (CRC) -

Experimental: Part 2A - Non-Small Cell Lung Cancer/Gastric Cancer (NSCLC/GC) -

Experimental: Part 1B -

Experimental: Part 2B -


Treatment: Drugs: BMS-986490
Specified dose on specified days.

Treatment: Drugs: Bevacizumab
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 participnats with Adverse Events (AEs)
Timepoint [1] 0 0
Up to 100 days following discontinuation of dosing
Primary outcome [2] 0 0
Number of participants with Serious AEs (SAEs)
Timepoint [2] 0 0
Up to 100 days following discontinuation of dosing
Primary outcome [3] 0 0
Number of participants with AEs meeting protocol-defined dose limiting toxicity (DLT) criteria
Timepoint [3] 0 0
Up to 28 days after the first treatment of study intervention
Primary outcome [4] 0 0
Number of participants with AEs leading to discontinuation
Timepoint [4] 0 0
Up to 100 days following discontinuation of dosing
Primary outcome [5] 0 0
Number of deaths
Timepoint [5] 0 0
Up to 100 days following discontinuation of dosing
Secondary outcome [1] 0 0
Area under the concentration-time curve in 1 dosing interval (AUC(TAU))
Timepoint [1] 0 0
Approximately 30 Days after Cycle 30, Day 1 (1 Cycle = 21 Days)
Secondary outcome [2] 0 0
Trough observed concentration (Ctrough)
Timepoint [2] 0 0
Approximately 30 Days after Cycle 30, Day 1 (1 Cycle = 21 Days)
Secondary outcome [3] 0 0
Maximum observed concentration (Cmax)
Timepoint [3] 0 0
Approximately 30 Days after Cycle 30, Day 1 (1 Cycle = 21 Days)
Secondary outcome [4] 0 0
Time of maximum observed concentration (Tmax)
Timepoint [4] 0 0
Approximately 30 Days after Cycle 30, Day 1 (1 Cycle = 21 Days)
Secondary outcome [5] 0 0
Total anti-drug antibodies (ADAs)
Timepoint [5] 0 0
Approximately 30 Days after Cycle 30, Day 1 (1 Cycle = 21 Days)
Secondary outcome [6] 0 0
Objective Response Rate (ORR) as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 assessed by Investigator
Timepoint [6] 0 0
Up to approximately 4 years

Eligibility
Key inclusion criteria
* Documented histologically or cytologically confirmed, advanced, unresectable/metastatic solid tumor measurable by RECIST v1.1.
* CRC: Part 1A, Part 2A-CRC, Part 1B, and Part 2B:.

i) Locally advanced/metastatic, recurrent, or unresectable CRC with adenocarcinoma histology and whose disease has progressed after systemic cancer therapy in the metastatic or adjuvant setting including 5-FU, irinotecan, and/or oxaliplatin (if available and not contraindicated).
* NSCLC: Part 2A-NSCLC/GC, 3L+ NSCLC:.

i) Histologically confirmed NSCLC meeting stage criteria for Stage IIIB, Stage IV, or recurrent disease.

ii) Progressed on at least 2 prior lines of therapy,

iii) Participants must have received and progressed on or after anti-PD-(L)1 therapy, if available.

- GC: Part 2A-NSCLC/GC, 2L+ GC:.

i) Participants must have received and then progressed or been intolerant to at least 1 standard treatment regimen in the advanced or metastatic setting (or have progressed within 6 months of adjuvant therapy).

ii) ECOG performance status of 0 or 1.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* History of anaphylactic reactions to irinotecan and/or bevacizumab.
* Previously received therapy targeting CEACAM5.
* Grade = 3 ILD/pneumonitis.
* Other protocol-defined Inclusion/Exclusion criteria apply.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled 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
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
12/02/2025
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
9/12/2029
Actual
Sample size
Target
360
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
Tasman Oncology Research - Southport
Recruitment postcode(s) [1] 0 0
4215 - Southport
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Michigan
Country [3] 0 0
United States of America
State/province [3] 0 0
New Jersey
Country [4] 0 0
United States of America
State/province [4] 0 0
Pennsylvania
Country [5] 0 0
Canada
State/province [5] 0 0
Ontario

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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
855-907-3286
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT06730750