A Phase Ia/Ib Dose-Escalation and Dose-Expansion Study Evaluating the Safety, Pharmacokinetics, and Activity of GDC-6036 as a Single Agent and in Combination With Other Anti-cancer Therapies in Patients With Advanced or Metastatic Solid Tumors With a KRAS G12C Mutation
Who is this study for? Patients with advanced or metastatic solid tumors with a KRAS G12C mutation
What treatments are being studied? GCD-6036
Status: Recruiting
Location: See all (74) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY
This is a Phase I dose-escalation and dose-expansion study that will evaluate the safety, pharmacokinetics (PK), and preliminary activity of GDC-6036 in patients with advanced or metastatic solid tumors with a KRAS G12C mutation.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Histologically documented advanced or metastatic solid tumor with KRAS G12C mutation.
• Women of childbearing potential must agree to remain abstinent or use contraception, and agree to refrain from donating eggs during the treatment period and after the final dose of study treatment as specified in the protocol.
• Men who are not surgically sterile must agree to remain abstinent or use a condom, and agreement to refrain from donating sperm during the treatment period and after the final dose of study treatment as specified in the protocol.
Locations
United States
California
City of Hope Comprehensive Cancer Center
COMPLETED
Duarte
UCSD Moores Cancer Center
RECRUITING
La Jolla
Chao Family Comprehensive Cancer Center UCI
COMPLETED
Orange
Univ of Calif, San Francisco
WITHDRAWN
San Francisco
Connecticut
Yale Cancer Center
RECRUITING
New Haven
Florida
Florida Cancer Specialists - Sarasota
COMPLETED
Sarasota
Massachusetts
Dana Farber Cancer Institute
RECRUITING
Boston
New York
Memorial Sloan Kettering Cancer Center
COMPLETED
New York
Oklahoma
University of Oklahoma
RECRUITING
Oklahoma City
Pennsylvania
Abramson Cancer Center
RECRUITING
Philadelphia
UPMC - Hillman Cancer Center
COMPLETED
Pittsburgh
Other Locations
Australia
St Vincent's Hospital Sydney
RECRUITING
Darlinghurst
Alfred Health
RECRUITING
Melbourne
Peter MacCallum Cancer Center
RECRUITING
Melbourne
Slade Health Inward goods
RECRUITING
Mount Kuring-gai
Linear Clinical Research Limited
RECRUITING
Nedlands
Belgium
UZ Antwerpen
COMPLETED
Edegem
CHU de Liège
RECRUITING
Liège
AZ St Maarten Campus Leopoldstr
ACTIVE_NOT_RECRUITING
Mechelen
Brazil
Hospital de Cancer de Barretos
COMPLETED
Barretos
Santa Casa de Misericordia de Belo Horizonte - PPDS
COMPLETED
Belo Horizonte
Universidade de Caxias do Sul
COMPLETED
Caxias Do Sul
Hospital Erasto Gaertner
COMPLETED
Curitiba
Hospital Sao Lucas Da Pontificia Universidade Catolica Do Rio Grande Do Sul (PUCRS)
COMPLETED
Porto Alegre
Hospital de Clinicas de Porto Alegre HCPA PPDS
RECRUITING
Pôrto Alegre
Instituto Nacional de Câncer
COMPLETED
Rio De Janeiro
Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto Hospital de Base - PPDS
RECRUITING
São José Do Rio Preto
Instituto do Cancer do Estado de Sao Paulo - ICESP
WITHDRAWN
São Paulo
Canada
Jewish General Hospital
RECRUITING
Montreal
Ottawa Hospital
COMPLETED
Ottawa
Princess Margaret Cancer Centre
RECRUITING
Toronto
Hungary
Semmelweis Egyetem
WITHDRAWN
Budapest
Clinexpert Gyongyos Kft
SUSPENDED
Gyöngyös
Israel
Rambam Medical Center
RECRUITING
Haifa
Sheba Medical Center - PPDS
RECRUITING
Ramat Gan
Tel-Aviv Sourasky Medical Center
RECRUITING
Tel Aviv
Italy
Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori IRST - PPDS
COMPLETED
Meldola
Asst Grande Ospedale Metropolitano Niguarda
COMPLETED
Milan
Irccs Ospedale San Raffaele
COMPLETED
Milan
Azienda Ospedaliero Universitaria Pisana
COMPLETED
Pisa
Istituto Clinico Humanitas
RECRUITING
Rozzano (mi)
Kenya
Aga Khan University Hospital
COMPLETED
Nairobi
Netherlands
Het Nederlands Kanker Instituut Antoni Van Leeuwenhoek Ziekenhuis
RECRUITING
Amsterdam
Leids Universitair Medisch Centrum
RECRUITING
Leiden
Maastricht University Medical Center
RECRUITING
Maastricht
Universitair Medisch Centrum Utrecht
RECRUITING
Utrecht
New Zealand
Auckland City Hospital
RECRUITING
Auckland
Auckland City Hospital, Cancer and Blood Research
RECRUITING
Auckland
New Zealand Clinical Research - Christchurch
RECRUITING
Christchurch
Norway
Haukeland University Hospital
COMPLETED
Bergen
Oslo university hospital Radiumhospitalet
RECRUITING
Oslo
Poland
Uniwersyteckie Centrum Kliniczne, O?rodek Bada? Klinicznych Wczesnych Faz
RECRUITING
Gdansk
Biokinetica, Przychodnia Jozefow
COMPLETED
Józefów
Uniwersytecki Szpital Kliniczny w Poznaniu
WITHDRAWN
Późna
Republic of Korea
Seoul National University Bundang Hospital
RECRUITING
Seongnam-si
Asan Medical Center - PPDS
COMPLETED
Seoul
Samsung Medical Center - PPDS
RECRUITING
Seoul
Seoul National University Hospital
RECRUITING
Seoul
Russian Federation
Republican Clinical Oncology Dispensary of Ministry of Healthcare of Tatarstan Republic
WITHDRAWN
Kazan'
Spain
Hospital Universitari Vall d'Hebron
RECRUITING
Barcelona
Hospital Universitario 12 de Octubre
RECRUITING
Madrid
Hospital Universitario HM Sanchinarro-CIOCC
COMPLETED
Madrid
START Madrid-FJD, Hospital Fundacion Jimenez Diaz
RECRUITING
Madrid
Hospital Clinico Universitario Virgen de la Victoria
RECRUITING
Málaga
Hospital Universitario Virgen del Rocío
COMPLETED
Seville
Hospital Clinico Universitario de Valencia
RECRUITING
Valencia
Switzerland
Universitaetsspital Basel
WITHDRAWN
Basel
Inselspital
RECRUITING
Bern
Hôpitaux Universitaires de Genève
RECRUITING
Geneva
Unversitätsspital Zürich
WITHDRAWN
Zurich
United Kingdom
Queen Elizabeth Hospital
RECRUITING
Birmingham
Velindre Cancer Centre
RECRUITING
Cardiff
University College London Hospitals NHS Foundation Trust
RECRUITING
London
The Christie NHS Foundation Trust
RECRUITING
Manchester
Contact Information
Primary
Reference Study ID Number: GO42144 whttps://forpatients.roche.com/
global-roche-genentech-trials@gene.com
888-662-6728 (U.S. and Canada)
Time Frame
Start Date: 2020-07-29
Estimated Completion Date: 2026-02-28
Participants
Target number of participants: 498
Treatments
Experimental: Arm A: Dose-escalation (Stage I), Dose Expansion (Stage II)
Participants in Stage I will receive GDC-6036 administered orally once daily (PO QD). The dose will be increased in successive cohorts until a study-specific threshold is reached.~Participants with select solid tumors will be treated with GDC-6036 PO QD in Stage II.
Experimental: Arm B: GDC-6036 + Atezolizumab (Stage I and Stage II)
Participants with non-small cell lung cancer will receive GDC-6036 in combination with atezolizumab.
Experimental: Arm C: GDC-6036 + Cetuximab (Stage I and Stage II)
Participants with colorectal cancer will receive GDC-6036 in combination with cetuximab.
Experimental: Arm D: GDC-6036 + Bevacizumab (Stage I and Stage II)
Participants with solid tumors will receive GDC-6036 in combination with bevacizumab.
Experimental: Arm E: GDC-6036 + Erlotinib (Stage I and Stage II)
Participants with non-small cell lung cancer will receive GDC-6036 in combination with erlotinib.
Experimental: Arm F: GDC-6036 + GDC-1971 (Stage I and Stage II)
Participants with solid tumors will receive GDC-6036 in combination with GDC-1971 PO in Stage I.~Participants with select solid tumors will be treated with GDC-6036 in combination with GDC-1971 PO in Stage II.
Experimental: Arm G: GDC-6036 + Inavolisib (Stage I and Stage II)
Participants with solid tumors will receive GDC-6036 in combination with inavolisib PO in Stage I.~Participants with select solid tumors will be treated with GDC-6036 in combination with inavolisib PO in Stage II.
Related Therapeutic Areas
Sponsors
Leads: Genentech, Inc.