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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05462717




Registration number
NCT05462717
Ethics application status
Date submitted
11/07/2022
Date registered
18/07/2022

Titles & IDs
Public title
Dose Escalation and Dose Expansion Study of RMC-6291 Monotherapy in Subjects With Advanced KRASG12C Mutant Solid Tumors
Scientific title
Phase 1/1b, Multicenter, Open-Label, Dose Escalation and Dose Expansion Study of RMC-6291 Monotherapy in Subjects With Advanced KRASG12C Mutant Solid Tumors
Secondary ID [1] 0 0
RMC-6291-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-Small Cell Lung Cancer (NSCLC) 0 0
Colorectal Cancer (CRC) 0 0
Pancreatic Ductal Adenocarcinoma 0 0
Advanced Solid Tumor 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Mesothelioma
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Lung - Small cell
Cancer 0 0 0 0
Bowel - Back passage (rectum) or large bowel (colon)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - RMC-6291

Experimental: RMC-6291 - Dose Escalation and Dose Expansion


Treatment: Drugs: RMC-6291
Oral tablet once or twice a day
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Adverse events
Timepoint [1] 0 0
up to 3 years
Primary outcome [2] 0 0
Dose Limiting Toxicities
Timepoint [2] 0 0
The first 21 days (i.e. Cycle 1)
Secondary outcome [1] 0 0
Maximum Observed Blood Concentration of RMC-6291
Timepoint [1] 0 0
7 Cycles
Secondary outcome [2] 0 0
Time to Reach Maximum Blood Concentration of RMC-6291
Timepoint [2] 0 0
7 Cycles
Secondary outcome [3] 0 0
Area Under Blood Concentration Time Curve of RMC-6291
Timepoint [3] 0 0
7 Cycles
Secondary outcome [4] 0 0
Elimination Half-Life of RMC-6291
Timepoint [4] 0 0
7 Cycles
Secondary outcome [5] 0 0
Ratio of accumulation of RMC-6291 from a single dose to steady state with repeated dosing
Timepoint [5] 0 0
7 Cycles
Secondary outcome [6] 0 0
Overall Response Rate (ORR)
Timepoint [6] 0 0
3 years
Secondary outcome [7] 0 0
Duration of Response (DOR)
Timepoint [7] 0 0
3 years
Secondary outcome [8] 0 0
Disease Control Rate (DCR)
Timepoint [8] 0 0
3 years
Secondary outcome [9] 0 0
Time to Response (TTR)
Timepoint [9] 0 0
3 years
Secondary outcome [10] 0 0
Progression-Free Survival (PFS)
Timepoint [10] 0 0
3 years

Eligibility
Key inclusion criteria
* Subject must be =18 years of age.
* Subject must have pathologically documented, locally advanced or metastatic KRASG12C-mutated solid tumor malignancy (not amenable to curative surgery) that has previously been treated with standard-of-care therapies for respective tumor types, is intolerant to, or is considered ineligible for standard-of-care anticancer treatments.
* ECOG performance status 0 or 1
* Prior treatment with a KRASG12C (OFF) inhibitor allowed for dose escalation
* Adequate organ function
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Primary central nervous system (CNS) tumors
* Active brain metastases
* Known impairment of GI function that would alter the absorption
* Major surgical procedures within 28 days or non-study-related minor procedures within 7 days of treatment.
* Prior therapy with KRASG12C (ON) inhibitor

Other inclusion/exclusion criteria may apply.

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
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
19/09/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2025
Actual
Sample size
Target
222
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Southside Cancer Care Centre - Sydney
Recruitment hospital [2] 0 0
Peninsula & South Eastern Haematology and Oncology Group - Frankston
Recruitment hospital [3] 0 0
Austin Health, Olivia Newton-John Cancer Research & Wellness Centre - Heidelberg
Recruitment hospital [4] 0 0
South West Health Care - Warrnambool
Recruitment postcode(s) [1] 0 0
2228 - Sydney
Recruitment postcode(s) [2] 0 0
3199 - Frankston
Recruitment postcode(s) [3] 0 0
3084 - Heidelberg
Recruitment postcode(s) [4] 0 0
3280 - Warrnambool
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arkansas
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Maryland
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
New York
Country [7] 0 0
United States of America
State/province [7] 0 0
Tennessee
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
Virginia
Country [10] 0 0
Czechia
State/province [10] 0 0
Horovice
Country [11] 0 0
Czechia
State/province [11] 0 0
Hradec Králové
Country [12] 0 0
Czechia
State/province [12] 0 0
Olomouc
Country [13] 0 0
France
State/province [13] 0 0
Angers
Country [14] 0 0
France
State/province [14] 0 0
Bordeaux
Country [15] 0 0
France
State/province [15] 0 0
Clermont-Ferrand
Country [16] 0 0
France
State/province [16] 0 0
Lille
Country [17] 0 0
France
State/province [17] 0 0
Lyon
Country [18] 0 0
France
State/province [18] 0 0
Nantes
Country [19] 0 0
France
State/province [19] 0 0
Strasbourg
Country [20] 0 0
Italy
State/province [20] 0 0
Milano
Country [21] 0 0
Italy
State/province [21] 0 0
Milan
Country [22] 0 0
Italy
State/province [22] 0 0
Napoli
Country [23] 0 0
Italy
State/province [23] 0 0
Orbassano
Country [24] 0 0
Italy
State/province [24] 0 0
Pavia
Country [25] 0 0
Italy
State/province [25] 0 0
Verona
Country [26] 0 0
Korea, Republic of
State/province [26] 0 0
Gyeonggi-do
Country [27] 0 0
Korea, Republic of
State/province [27] 0 0
Seoul
Country [28] 0 0
Malaysia
State/province [28] 0 0
Kuala Lumpur
Country [29] 0 0
Malaysia
State/province [29] 0 0
Kuching
Country [30] 0 0
Poland
State/province [30] 0 0
Poznan
Country [31] 0 0
Poland
State/province [31] 0 0
Warsaw
Country [32] 0 0
Poland
State/province [32] 0 0
Lódz
Country [33] 0 0
Serbia
State/province [33] 0 0
Belgrade
Country [34] 0 0
Serbia
State/province [34] 0 0
Sremska Kamenica
Country [35] 0 0
Singapore
State/province [35] 0 0
Singapore
Country [36] 0 0
Spain
State/province [36] 0 0
Barcelona
Country [37] 0 0
Spain
State/province [37] 0 0
Madrid
Country [38] 0 0
Spain
State/province [38] 0 0
Pamplona
Country [39] 0 0
Spain
State/province [39] 0 0
Pozuelo De Alarcón
Country [40] 0 0
Spain
State/province [40] 0 0
Sevilla
Country [41] 0 0
Spain
State/province [41] 0 0
Zaragoza
Country [42] 0 0
Taiwan
State/province [42] 0 0
Yanchao District
Country [43] 0 0
Taiwan
State/province [43] 0 0
New Taipei City
Country [44] 0 0
Taiwan
State/province [44] 0 0
Tainan
Country [45] 0 0
Taiwan
State/province [45] 0 0
Taipei
Country [46] 0 0
Thailand
State/province [46] 0 0
Bangkok Noi
Country [47] 0 0
Thailand
State/province [47] 0 0
Chiang Mai
Country [48] 0 0
Thailand
State/province [48] 0 0
Khon Kaen

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Revolution Medicines, Inc.
Address
Country

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Revolution Medicines, Inc.
Address 0 0
Revolution Medicines, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Revolution Medicines, Inc.
Address 0 0
Country 0 0
Phone 0 0
(650) 779-2300
Fax 0 0
Email 0 0
CT-inquiries@RevMed.com
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/NCT05462717