Dose Escalation and Dose Expansion Study of RMC-6291 Monotherapy in Subjects With Advanced KRASG12C Mutant Solid Tumors
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ClinicalTrials.gov Identifier: NCT05462717 |
Recruitment Status :
Recruiting
First Posted : July 18, 2022
Last Update Posted : April 19, 2024
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Sponsor:
Revolution Medicines, Inc.
Information provided by (Responsible Party):
Revolution Medicines, Inc.
Tracking Information | |||||
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First Submitted Date ICMJE | July 11, 2022 | ||||
First Posted Date ICMJE | July 18, 2022 | ||||
Last Update Posted Date | April 19, 2024 | ||||
Actual Study Start Date ICMJE | September 19, 2022 | ||||
Estimated Primary Completion Date | November 2024 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Dose Escalation and Dose Expansion Study of RMC-6291 Monotherapy in Subjects With Advanced KRASG12C Mutant Solid Tumors | ||||
Official Title ICMJE | Phase 1/1b, Multicenter, Open-Label, Dose Escalation and Dose Expansion Study of RMC-6291 Monotherapy in Subjects With Advanced KRASG12C Mutant Solid Tumors | ||||
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. | ||||
Detailed Description | This is an open-label, multicenter, Phase 1/1b study of RMC-6291 monotherapy in subjects with advanced KRASG12C-mutant solid tumors. The study will include 2 components: a Dose-Escalation and a Dose-Expansion. Subjects will be treated until disease progression per RECIST v1.1, unacceptable toxicity, or other criteria for withdrawal are met, whichever occurs first. | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 1 | ||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE | Drug: RMC-6291
Oral tablet once or twice a day
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Study Arms ICMJE | Experimental: RMC-6291
Dose Escalation and Dose Expansion
Intervention: Drug: RMC-6291
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Recruiting | ||||
Estimated Enrollment ICMJE |
222 | ||||
Original Estimated Enrollment ICMJE |
117 | ||||
Estimated Study Completion Date ICMJE | December 2025 | ||||
Estimated Primary Completion Date | November 2024 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
Other inclusion/exclusion criteria may apply. |
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE |
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Listed Location Countries ICMJE | Australia, Czechia, France, Italy, Korea, Republic of, Malaysia, Poland, Serbia, Singapore, Spain, Taiwan, Thailand, United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT05462717 | ||||
Other Study ID Numbers ICMJE | RMC-6291-001 | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | Revolution Medicines, Inc. | ||||
Original Responsible Party | Same as current | ||||
Current Study Sponsor ICMJE | Revolution Medicines, Inc. | ||||
Original Study Sponsor ICMJE | Same as current | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
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PRS Account | Revolution Medicines, Inc. | ||||
Verification Date | April 2024 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |