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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

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
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
17/02/2025
Actual
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
Local Institution - 0012 - 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
Clinical.Trials@bms.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria.

Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at:

https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosurecommitment.html

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
When will data be available (start and end dates)?
See Plan Description
Available to whom?
See Plan Description
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosure-commitment.html


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