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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06024174




Registration number
NCT06024174
Ethics application status
Date submitted
29/08/2023
Date registered
6/09/2023

Titles & IDs
Public title
A Study of BMS-986466 With Adagrasib With or Without Cetuximab in Participants With Kirsten Rat Sarcoma Virus Glycine 12 to Cysteine (KRAS G12C)-Mutant Solid Tumors
Scientific title
Phase 1/2 Open-label Study of BMS-986466 in Combination With Adagrasib With or Without Cetuximab in Participants With KRAS G12C-mutant Advanced Solid Tumors
Secondary ID [1] 0 0
2023-505070-15
Secondary ID [2] 0 0
CA126-0015
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-986466
Treatment: Drugs - Adagrasib
Treatment: Drugs - Cetuximab

Experimental: Part 1: DDI Cohort -

Experimental: Part 1: Dose Escalation -

Experimental: Part 2: Dose Expansion -


Treatment: Drugs: BMS-986466
Specified dose on specified days

Treatment: Drugs: Adagrasib
Specified dose on specified days

Treatment: Drugs: Cetuximab
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 dose limiting toxicity (DLTs)
Timepoint [1] 0 0
Up to 28 days
Primary outcome [2] 0 0
Number of participants with adverse events (AEs)
Timepoint [2] 0 0
Up to approximately 2 years
Primary outcome [3] 0 0
Number of participants with serious adverse events (SAEs)
Timepoint [3] 0 0
Up to approximately 2 years
Primary outcome [4] 0 0
Number of participants with AEs leading to discontinuation
Timepoint [4] 0 0
Up to approximately 2 years
Primary outcome [5] 0 0
Number of participants with deaths
Timepoint [5] 0 0
Up to approximately 2 years
Primary outcome [6] 0 0
Overall response rate (ORR) assessed by Blinded Independent Central Review (BICR) as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Timepoint [6] 0 0
Up to approximately 4 years
Secondary outcome [1] 0 0
Maximum observed plasma concentration (Cmax)
Timepoint [1] 0 0
Up to approximately 60 days
Secondary outcome [2] 0 0
Time to maximum concentration (Tmax)
Timepoint [2] 0 0
Up to approximately 60 days
Secondary outcome [3] 0 0
Area under the serum concentration-time curve from time zero to the time of the last quantifiable concentration (AUC[0-T])
Timepoint [3] 0 0
Up to approximately 60 days
Secondary outcome [4] 0 0
Progression-free survival (PFS) assessed by BICR as per RECIST v1.1
Timepoint [4] 0 0
Up to approximately 4 years
Secondary outcome [5] 0 0
Disease Control Rate (DCR) assessed by BICR as per RECIST v1.1
Timepoint [5] 0 0
Up to approximately 4 years
Secondary outcome [6] 0 0
Duration of Response (DOR) assessed by BICR as per RECIST v1.1
Timepoint [6] 0 0
Up to approximately 4 years
Secondary outcome [7] 0 0
Time to response (TTR)
Timepoint [7] 0 0
Up to approximately 4 years
Secondary outcome [8] 0 0
Number of participants with adverse events (AEs)
Timepoint [8] 0 0
Up to approximately 2 years
Secondary outcome [9] 0 0
Number of participants with serious adverse events (SAEs)
Timepoint [9] 0 0
Up to approximately 2 years
Secondary outcome [10] 0 0
Number of participants with AEs leading to discontinuation
Timepoint [10] 0 0
Up to approximately 2 years
Secondary outcome [11] 0 0
Number of participants with deaths
Timepoint [11] 0 0
Up to approximately 2 years
Secondary outcome [12] 0 0
Pharmacodynamic (PD) profile as measured by phosphorylation of extracellular signal-regulated kinase (pERK) levels in blood
Timepoint [12] 0 0
Up to approximately 30 days

Eligibility
Key inclusion criteria
Key

Part 1:

* Individuals with a confirmed diagnosis of advanced KRAS G12C mutant NSCLC, CRC, PDAC and BTC that has spread to other parts of the body and cannot be removed surgically, may or may not have received previous treatment with KRAS G12C inhibitors.
* For NSCLC and CRC: Individuals must have a documented KRAS G12C mutation status from NYS or FDA approved/cleared or CE marked test or, when such result is not available, positive KRAS G12C mutation status should be confirmed by a central laboratory in blood sample collected at the time of screening.
* For PDAC and BTC: Participants must have a documented KRAS G12Cmutation from NYS or FDA-approved/cleared, or CE-marked test and blood samples will be collected only for retrospective testing.
* Are relapsed or refractory to available standard of care treatments.

Part 2:

* Individuals with a confirmed diagnosis of advanced KRAS G12C-mutant NSCLC (Part 2A) or CRC (Part 2B) that has spread to other parts of the body and cannot be removed surgically and have not received previous treatment with KRAS inhibitors.
* Individuals must have a documented KRAS G12C mutation from FDA or NYS approved/ cleared or CE marked test or, when such result is not available, positive KRAS G12C mutation status should be confirmed by a central laboratory in blood sample and /or tumor samples collected at the time of screening or from archival biopsies (less than 1 year old).
* Have failed or disease recurrence or are not able to tolerate after at least 1 pervious line of therapy.

Key
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Have tumors with known BARF V600X, PTPN11 or KRASQ61X mutations.
* Have or any significant heart disease or condition.
* Receiving any medications that are substrate of CYP3A4 or inducers and/ or inhibitors

Note: 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
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
9/11/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
13/05/2024
Sample size
Target
Accrual to date
Final
5
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Local Institution - 0053 - Westmead
Recruitment postcode(s) [1] 0 0
2145 - Westmead
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
Georgia
Country [3] 0 0
United States of America
State/province [3] 0 0
New Jersey
Country [4] 0 0
Finland
State/province [4] 0 0
Helsinki
Country [5] 0 0
France
State/province [5] 0 0
Lille
Country [6] 0 0
Israel
State/province [6] 0 0
HaMerkaz
Country [7] 0 0
Israel
State/province [7] 0 0
Tell Abib

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
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
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 Myers Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosure-commitment.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/disclosurecommitment.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/NCT06024174