Dose Escalation and Dose Expansion Study of RMC-6291 Monotherapy in Subjects With Advanced KRASG12C Mutant Solid Tumors
- Trial number:
- NCT05462717
- Trial phase:
- 1
- Study type:
- Immunotherapy
- Overall status:
- Recruiting
Study start date
September, 2022
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
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.
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
Study design
Primary purpose:
Treatment, Allocation:
N/A, Intervention model:
Single Group Assignment, Masking:
None (Open Label),
Conditions
Non-Small Cell Lung Cancer (NSCLC), Colorectal Cancer (CRC), Pancreatic Ductal Adenocarcinoma, Advanced Solid Tumor
Other study ID numbers
RMC-6291-001
Choose trial site (66)
Highlands Oncology Group
3901 Parkway Cir Suite 100, Springdale, AR 72762, USA
American Oncology Partners of Maryland
Westlake, MD 20817, USA
Tennessee Oncology
2004 Hayes St #350, Nashville, TN 37203, USA
Next Oncology
2829 Babcock Rd #300, San Antonio, TX 78229, USA
START
4383 Medical Dr, San Antonio, TX 78229, USA
Next Oncology Virginia
Fairfax, VA, USA
UC Irvine Cancer Center
101 The City Dr S Bldg. 23, Orange, CA 92868, USA
UC Davis Cancer Center
4501 X St, Sacramento, CA 95817, USA
Moffitt Cancer Center
12902 USF Magnolia Drive, Tampa, FL 33612, USA
Dana-Farber Cancer Institute
Boston, MA 02215, USA
MSK Cancer Center
530 E 74th St, New York, NY 10021, USA
Columbia University Irving Medical Center
622 W 168th St, New York, NY 10032, USA
ICO
Angers, France
Centre Oscar Lambret
3 Rue Frédéric Combemale, 59000 Lille, France
ICANS
17 Rue Albert Calmette, 67200 Strasbourg, France
Med - Polonia Sp. z o. o.
Obornicka 262, 60-693 Poznań, Poland
Instytut MSF Sp zoo
90-302 Łódź, Poland
UCSF
San Francisco, CA 94158, USA
University of Miami School of Medicine Sylvester Comprehensive Cancer Center
1475 NW 12th Ave, Miami, FL 33136, USA
Slade Pharmacy Frankston
Public Surgical Centre, Ground Floor/5 Susono Way, Frankston VIC 3199, Australia
Centre Jean Perrin
58 Rue Montalembert, 63011 Clermont-Ferrand, France
CHU Nantes
Nantes, France
Istituto Nazionale Tumori Fondazione G. Pascale
Via Mariano Semmola, 53, 80131 Napoli NA, Italy
Ajou University Hospital
164 World cup-ro, 원천동 Yeongtong-gu, Suwon-si, Gyeonggi-do, South Korea
Korea University Hospital
145 Anam-ro, Seongbuk-gu, Seoul, South Korea
Seoul National University Hospital
101 Daehak-ro, Jongno-gu, Seoul, South Korea
Sarawak General Hospital
Jalan Hospital, 93586 Kuching, Sarawak, Malaysia
National Cancer Centre Singapore
30 Hospital Blvd, Singapore 168583
Clinica Universidad de Navarra
Av. de Pío XII, 36, 31008 Pamplona, Navarra, Spain
E-DA hospital
No. 1號, Yida Rd, Yanchao District, Kaohsiung City, Taiwan 824
Taipei Tzu Chi Hospital
No. 289, Jianguo Rd, Xindian District, New Taipei City, Taiwan 231
Peninsula & South Eastern Haematology and Oncology Group
Frankston VIC 3199, Australia
Roswell Park Comprehensive Cancer Center
665 Elm St, Buffalo, NY 14203, USA
Southside Cancer Care Centre
3/533 Kingsway, Miranda NSW 2228, Australia
Klinika onkologie a radioterapie, Fakultni Nemocnice Hradec Kralove
Sokolská 581, 500 05 Hradec Králové, Czechia
CHU Bordeaux Hospital Saint-Andre
1 Rue Jean Burguet, 33000 Bordeaux, France
Fondazione IRCCS Policlinico San Matteo
27100 Pavia, Province of Pavia, Italy
Centro Ricerche Cliniche di Verona s.r.l.
Piazzale L.A. Scuro, 10, 37134 Verona VR, Italy
Severance Hospital
50-1 Yonsei-ro, Sinchon-dong, Seodaemun-gu, Seoul, South Korea
NEXT Oncology IOB Hospital Quirónsalud
Plaça d'Alfonso Comín, 5, 08023 Barcelona, Spain
Hospital Universitario Quirónsalud
C. Diego de Velázquez, 1, 28223 Pozuelo de Alarcón, Madrid, Spain
Hospital Universitario Virgen del Rocío
Av. Manuel Siurot, S/n, 41013 Sevilla, Spain
Hospital Universitario Miguel Servet
P.º de Isabel la Católica, 1-3, 50009 Zaragoza, Spain
National Cheng Kung University Hospital
No. 138號, Shengli Rd, North District, Tainan City, Taiwan 704
National Taiwan University Hospital
No. 7號, Zhongshan S Rd, Zhongzheng District, Taipei City, Taiwan 100
Peninsula & South Eastern Haematology and Oncology Group
Frankston VIC 3199, Australia
Austin Health, Olivia Newton-John Cancer Research & Wellness Centre
Level 5, ONJ Centre, 145 Studley Rd, Heidelberg VIC 3084, Australia
South West Health Care
25 Ryot St, Warrnambool VIC 3280, Australia
NH Hospital a.s.
268 01 Horovice-Hořovice, Czechia
Onkologicka klinika, Fakultni Nemocnice Olomouc
Zdravotníků 248/7, 779 00 Olomouc-Olomouc 9, Czechia
Centre Léon Bérard
28 Prom. Léa et Napoléon Bullukian, 69008 Lyon, France
Istituto Europeo Oncologico
Via Giuseppe Ripamonti, 435, 20141 Milano MI, Italy
S.C. Oncologia Falck, Dipartimento Ematologia ed Oncologia Niguarda Cancer Center
Ospedale, Piazza dell'Ospedale Maggiore, 3, 20162 Milano MI, Italy
Narodowy Instytut Onkologii
Wilhelma Konrada Roentgena 5, 02-781 Warszawa, Poland
Hospital Universitario Fundación Jiménez Díaz
Av. de los Reyes Católicos, 2, Moncloa - Aravaca, 28040 Madrid, Spain
Siriraj Hospital
2 Thanon Wang Lang, Khwaeng Siriraj, Khet Bangkok Noi, Krung Thep Maha Nakhon 10700, Thailand
Chiang Mai University
239 Huay Kaew Rd, Tambon Su Thep, Amphoe Mueang Chiang Mai, Chang Wat Chiang Mai 50200, Thailand
Khon Kaen University
Khon Kaen, Mueang Khon Kaen District, Khon Kaen 40000, Thailand