Ovarian Cancer Clinical Trial
Dose Escalation and Dose Expansion Study of RMC-6291 Monotherapy in Subjects With Advanced KRASG12C Mutant Solid Tumors
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.
Full 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.
Eligibility Criteria
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
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.
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There are 30 Locations for this study
Springdale Arkansas, 72762, United States
Orange California, 92868, United States
Sacramento California, 95817, United States
San Francisco California, 94158, United States
Miami Florida, 33136, United States
Tampa Florida, 33612, United States
Bethesda Maryland, 20817, United States
Boston Massachusetts, 02215, United States
New York New York, 10021, United States
New York New York, 10032, United States
Nashville Tennessee, 37203, United States
San Antonio Texas, 78229, United States
San Antonio Texas, 78229, United States
Fairfax Virginia, 22031, United States
Frankston , 3199, Australia
Angers , 49055, France
Clermont-Ferrand , 63011, France
Lille , 59000, France
Nantes , 44093, France
Strasbourg , 67200, France
Napoli , 80131, Italy
Suwon-si Gyeonggi-do, 16499, Korea, Republic of
Seoul , 02708, Korea, Republic of
Seoul , 3080, Korea, Republic of
Kuching , 93586, Malaysia
Poznań , 60-69, Poland
Åódź , 90-30, Poland
Singapore , 16858, Singapore
Pamplona , 31008, Spain
Kaohsiung Yanchao District, 82445, Taiwan
New Taipei City , 231, Taiwan
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