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.

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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.

View Eligibility Criteria

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.

Study is for people with:

Ovarian Cancer

Phase:

Phase 1

Estimated Enrollment:

222

Study ID:

NCT05462717

Recruitment Status:

Recruiting

Sponsor:

Revolution Medicines, Inc.

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There are 63 Locations for this study

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Highlands Oncology Group
Springdale Arkansas, 72762, United States
UC Irvine Cancer Center
Orange California, 92868, United States
UC Davis Cancer Center
Sacramento California, 95817, United States
UCSF
San Francisco California, 94158, United States
University of Miami School of Medicine Sylvester Comprehensive Cancer Center
Miami Florida, 33136, United States
Moffitt Cancer Center
Tampa Florida, 33612, United States
American Oncology Partners of Maryland
Bethesda Maryland, 20817, United States
Dana-Farber Cancer Institute
Boston Massachusetts, 02215, United States
Roswell Park Comprehensive Cancer Center
Buffalo New York, 14203, United States
MSK Cancer Center
New York New York, 10021, United States
Columbia University Irving Medical Center
New York New York, 10032, United States
Tennessee Oncology
Nashville Tennessee, 37203, United States
Next Oncology
San Antonio Texas, 78229, United States
START
San Antonio Texas, 78229, United States
Next Oncology Virginia
Fairfax Virginia, 22031, United States
Southside Cancer Care Centre
Sydney New South Wales, 2228, Australia
Peninsula & South Eastern Haematology and Oncology Group
Frankston Victoria, 3199, Australia
Austin Health, Olivia Newton-John Cancer Research & Wellness Centre
Heidelberg Victoria, 3084, Australia
South West Health Care
Warrnambool Victoria, 3280, Australia
NH Hospital a.s.
Hořovice , 268 3, Czechia
Klinika onkologie a radioterapie, Fakultni Nemocnice Hradec Kralove
Hradec Králové , 50005, Czechia
Onkologicka klinika, Fakultni Nemocnice Olomouc
Olomouc , 77900, Czechia
ICO
Angers , 49055, France
CHU Bordeaux Hospital Saint-Andre
Bordeaux , 33000, France
Centre Jean Perrin
Clermont-Ferrand , 63011, France
Centre Oscar Lambret
Lille , 59000, France
Centre Léon Bérard
Lyon , 69008, France
CHU Nantes
Nantes , 44093, France
ICANS
Strasbourg , 67200, France
Istituto Europeo Oncologico
Milano , 20141, Italy
S.C. Oncologia Falck, Dipartimento Ematologia ed Oncologia Niguarda Cancer Center
Milan , 20162, Italy
Istituto Nazionale Tumori Fondazione G. Pascale
Napoli , 80131, Italy
Azienda Ospedaliero-Universitaria San Luigi Gonzaga
Orbassano , 10043, Italy
Fondazione IRCCS Policlinico San Matteo
Pavia , 27100, Italy
Centro Ricerche Cliniche di Verona s.r.l.
Verona , 37134, Italy
Ajou University Hospital
Suwon-si Gyeonggi-do, 16499, Korea, Republic of
Korea University Hospital
Seoul , 02708, Korea, Republic of
Seoul National University Hospital
Seoul , 3080, Korea, Republic of
Severance Hospital
Seoul , 3722, Korea, Republic of
University Malaya Medical Centre
Kuala Lumpur , 59100, Malaysia
Sarawak General Hospital
Kuching , 93586, Malaysia
Med - Polonia Sp. z o. o.
Poznań , 60-69, Poland
Narodowy Instytut Onkologii
Warsaw , 02-78, Poland
Instytut MSF Sp zoo
Łódź , 90-30, Poland
MSB General Hospital
Belgrade , 11000, Serbia
Clinical hospital center Bezanijska Kosa
Belgrade , 11071, Serbia
Institute for pulmonary diseases Sremska Kamenica
Sremska Kamenica , 21204, Serbia
National Cancer centre Singapore
Singapore , 16858, Singapore
NEXT Oncology IOB Hospital Quirónsalud
Barcelona , 08023, Spain
ICO Hospitalet
Barcelona , 08908, Spain
Clínica Universidad de Navarra
Madrid , 28027, Spain
MD Anderson Cancer Center
Madrid , 28033, Spain
Hospital Universitario Fundación Jiménez Díaz
Madrid , 28040, Spain
Clinica Universidad de Navarra
Pamplona , 31008, Spain
Hospital Universitario Quirónsalud
Pozuelo De Alarcón , 28223, Spain
Hospital Universitario Virgen del Rocío
Sevilla , 41013, Spain
Hospital Universitario Miguel Servet
Zaragoza , 50009, Spain
E-DA hospital
Kaohsiung Yanchao District, 82445, Taiwan
Taipei Tzu Chi Hospital
New Taipei City , 231, Taiwan
National Cheng Kung University Hospital
Tainan , 70457, Taiwan
National Taiwan University Hospital
Taipei , 10048, Taiwan
Siriraj Hospital
Bangkok Noi , 10700, Thailand
Chiang Mai University
Chiang Mai , 50200, Thailand
Khon Kaen University
Khon Kaen , 40002, Thailand

How clear is this clinincal trial information?

Study is for people with:

Ovarian Cancer

Phase:

Phase 1

Estimated Enrollment:

222

Study ID:

NCT05462717

Recruitment Status:

Recruiting

Sponsor:


Revolution Medicines, Inc.

How clear is this clinincal trial information?

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