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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06244771




Registration number
NCT06244771
Ethics application status
Date submitted
19/01/2024
Date registered
6/02/2024
Date last updated
11/09/2025

Titles & IDs
Public title
A Study Evaluating FMC-376 in Participants With KRAS G12C Mutated Solid Tumors
Scientific title
An Open-Label, Phase 1/2 Dose Escalation, Dose Expansion and Cohort Expansion Study Evaluating the Safety, PK and Clinical Activity of FMC-376 in Participants With KRAS G12C Mutated Locally Advanced Unresectable or Metastatic Solid Tumors
Secondary ID [1] 0 0
FMC-376-CL101
Universal Trial Number (UTN)
Trial acronym
PROSPER
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced Solid Tumors With KRAS G12C Mutations 0 0
Solid Tumor, Adult 0 0
Unresectable Solid Tumor 0 0
Metastatic Solid Tumor 0 0
Non Small Cell Lung Cancer 0 0
Colorectal Cancer 0 0
KRAS G12C 0 0
Pancreatic Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Bowel - Back passage (rectum) or large bowel (colon)
Cancer 0 0 0 0
Pancreatic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - FMC-376

Experimental: FMC-376 - Dose Escalation, Dose Expansion, and Cohort Expansion; Administered for 21-day cycle


Treatment: Drugs: FMC-376
Oral Capsule
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Dose Limiting Toxicities
Timepoint [1] 0 0
Up to 21 Days
Primary outcome [2] 0 0
Adverse Events (AEs)
Timepoint [2] 0 0
Approximately 24 Months
Secondary outcome [1] 0 0
Maximum Observed Plasma Concentration (Cmax) of FMC-376
Timepoint [1] 0 0
Approximately 24 Months
Secondary outcome [2] 0 0
Time to Reach Maximum Blood Concentration (Tmax) of FMC-376
Timepoint [2] 0 0
Approximately 24 Months
Secondary outcome [3] 0 0
Minimum Observed Plasma Concentration (Cmin) of FMC-376
Timepoint [3] 0 0
Approximately 24 Months
Secondary outcome [4] 0 0
Elimination Half-life (t1/2) of FMC-376
Timepoint [4] 0 0
Approximately 24 Months
Secondary outcome [5] 0 0
Area Under Blood Concentration-Time Curve (AUC) of FMC-376
Timepoint [5] 0 0
Approximately 24 Months
Secondary outcome [6] 0 0
Volume of Distribution (Vd) of FMC-376
Timepoint [6] 0 0
Approximately 24 Months
Secondary outcome [7] 0 0
Clearance (CL) of FMC-376 from Blood Plasma
Timepoint [7] 0 0
Approximately 24 Months
Secondary outcome [8] 0 0
Overall Response Rate (ORR)
Timepoint [8] 0 0
Approximately 24 Months
Secondary outcome [9] 0 0
Duration of Response (DOR)
Timepoint [9] 0 0
Approximately 24 Months
Secondary outcome [10] 0 0
Disease Control Rate (DCR)
Timepoint [10] 0 0
Approximately 24 Months
Secondary outcome [11] 0 0
Progression-Free Survival (PFS)
Timepoint [11] 0 0
Approximately 24 Months
Secondary outcome [12] 0 0
Overall Survival (OS)
Timepoint [12] 0 0
Approximately 24 Months

Eligibility
Key inclusion criteria
* Histologically or cytologically confirmed locally advanced unresectable or metastatic solid tumors with KRAS G12C mutation
* Received and progressed or been intolerant to prior standard therapy OR standard therapy is considered inappropriate OR an investigational agent is considered standard of care
* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
* Adequate hematological, renal, and hepatic function
* Agrees not to participate in another interventional study while receiving study drug
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Leptomeningeal disease or carcinomatous meningitis
* Clinically significant toxicity resulting from prior cancer therapies
* Known or suspected hypersensitivity to FMC-376 or any components of the study drug
* Condition that would interfere with study drug absorption
* Any illness or medical history that would impact safety or compliance with study requirements or impact ability to interpret study data

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
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
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
12/02/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/04/2028
Actual
Sample size
Target
403
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Macquarie University - Macquarie Park
Recruitment hospital [2] 0 0
Tasman Health Care - Southport
Recruitment hospital [3] 0 0
Icon Cancer Centre Kurralta Park - Kurralta Park
Recruitment hospital [4] 0 0
GenesisCare North Adelaide - North Adelaide
Recruitment hospital [5] 0 0
Eastern Health - Box Hill Hospital - Box Hill
Recruitment hospital [6] 0 0
Linear Clinical Research Ltd - Nedlands
Recruitment postcode(s) [1] 0 0
2109 - Macquarie Park
Recruitment postcode(s) [2] 0 0
4215 - Southport
Recruitment postcode(s) [3] 0 0
5037 - Kurralta Park
Recruitment postcode(s) [4] 0 0
5006 - North Adelaide
Recruitment postcode(s) [5] 0 0
3128 - Box Hill
Recruitment postcode(s) [6] 0 0
6009 - Nedlands
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
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Indiana
Country [4] 0 0
United States of America
State/province [4] 0 0
Kansas
Country [5] 0 0
United States of America
State/province [5] 0 0
Massachusetts
Country [6] 0 0
United States of America
State/province [6] 0 0
Michigan
Country [7] 0 0
United States of America
State/province [7] 0 0
Pennsylvania
Country [8] 0 0
United States of America
State/province [8] 0 0
Texas
Country [9] 0 0
United States of America
State/province [9] 0 0
Utah
Country [10] 0 0
United States of America
State/province [10] 0 0
Virginia

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Frontier Medicines Corporation
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Medical Lead
Address 0 0
Frontier Medicines Corporation
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Medical Lead
Address 0 0
Country 0 0
Phone 0 0
+1 (650) 457-1005
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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/NCT06244771