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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05462717




Registration number
NCT05462717
Ethics application status
Date submitted
11/07/2022
Date registered
18/07/2022
Date last updated
19/04/2024

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
N/A
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
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
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK)
of escalating doses of RMC-6291 (KRAS G12C(ON) inhibitor) monotherapy in adult subjects with
advanced solid tumors and to identify the maximum tolerated dose (MTD), and the recommended
Phase 2 dose.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05462717
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05462717