Trial Title:
A Study to Evaluate the Safety, Pharmacokinetics, and Activity of GDC-6036 Alone or in Combination in Participants With Advanced or Metastatic Solid Tumors With a KRAS G12C Mutation
NCT ID:
NCT04449874
Condition:
Non-Small Cell Lung Cancer
Colorectal Cancer
Advanced Solid Tumors
Conditions: Official terms:
Carcinoma, Non-Small-Cell Lung
Colorectal Neoplasms
Bevacizumab
Cetuximab
Atezolizumab
Erlotinib Hydrochloride
Inavolisib
Conditions: Keywords:
KRAS G12C
Non-Small Cell Lung Cancer
Colorectal Cancer
GDC-6036
Metastatic Solid Tumor
Atezolizumab
Bevacizumab
Cetuximab
Erlotinib
Inavolisib
GDC-1971
SHP2
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
GDC-6036
Description:
The starting dose of GDC-6036 in the combination Arms B, C, D, E, F and G will be
determined from Stage I Arm A (single-agent dose escalation).
Arm group label:
Arm A: Dose-escalation (Stage I), Dose Expansion (Stage II)
Arm group label:
Arm B: GDC-6036 + Atezolizumab (Stage I and Stage II)
Arm group label:
Arm C: GDC-6036 + Cetuximab (Stage I and Stage II)
Arm group label:
Arm D: GDC-6036 + Bevacizumab (Stage I and Stage II)
Arm group label:
Arm E: GDC-6036 + Erlotinib (Stage I and Stage II)
Arm group label:
Arm F: GDC-6036 + GDC-1971 (Stage I and Stage II)
Arm group label:
Arm G: GDC-6036 + Inavolisib (Stage I and Stage II)
Intervention type:
Drug
Intervention name:
Atezolizumab
Description:
A 1200 milligram (mg) intravenous (IV) infusion of atezolizumab will be administered on
Day 1 of 21 day cycles.
Arm group label:
Arm B: GDC-6036 + Atezolizumab (Stage I and Stage II)
Intervention type:
Drug
Intervention name:
Cetuximab
Description:
Cetuximab will be administered at an initial dose of 400 milligram per square meter
(mg/m^2) IV infusion followed by 250 mg/m^2 IV infusion weekly in 21 day cycles.
Arm group label:
Arm C: GDC-6036 + Cetuximab (Stage I and Stage II)
Intervention type:
Drug
Intervention name:
Bevacizumab
Description:
A 15 milligram per kilogram (mg/kg) IV infusion of bevacizumab will be administered on
Day 1 of 21 day cycles.
Arm group label:
Arm D: GDC-6036 + Bevacizumab (Stage I and Stage II)
Intervention type:
Drug
Intervention name:
Erlotinib
Description:
150 mg of erlotinib will be administered PO QD in 21 day cycles.
Arm group label:
Arm E: GDC-6036 + Erlotinib (Stage I and Stage II)
Intervention type:
Drug
Intervention name:
GDC-1971
Description:
The starting dose of GDC-1971 will be determined from its single-agent dose escalation.
Arm group label:
Arm F: GDC-6036 + GDC-1971 (Stage I and Stage II)
Intervention type:
Drug
Intervention name:
Inavolisib
Description:
The starting dose of inavolisib will be determined from its single-agent dose escalation.
Arm group label:
Arm G: GDC-6036 + Inavolisib (Stage I and Stage II)
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Active brain metastases.
- Malabsorption or other condition that interferes with enteral absorption.
- Clinically significant cardiovascular dysfunction or liver disease.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
City of Hope Comprehensive Cancer Center
Address:
City:
Duarte
Zip:
91010
Country:
United States
Status:
Completed
Facility:
Name:
UCSD Moores Cancer Center
Address:
City:
La Jolla
Zip:
92093
Country:
United States
Status:
Recruiting
Facility:
Name:
Chao Family Comprehensive Cancer Center UCI
Address:
City:
Orange
Zip:
92868
Country:
United States
Status:
Recruiting
Facility:
Name:
Univ of Calif, San Francisco; Breast Cancer Center
Address:
City:
San Francisco
Zip:
94115
Country:
United States
Status:
Withdrawn
Facility:
Name:
Yale Cancer Center
Address:
City:
New Haven
Zip:
06520
Country:
United States
Status:
Recruiting
Facility:
Name:
Florida Cancer Specialists - Sarasota
Address:
City:
Sarasota
Zip:
34232
Country:
United States
Status:
Recruiting
Facility:
Name:
Dana Farber Cancer Institute
Address:
City:
Boston
Zip:
02215
Country:
United States
Status:
Recruiting
Facility:
Name:
Memorial Sloan Kettering Cancer Center
Address:
City:
New York
Zip:
11101
Country:
United States
Status:
Recruiting
Facility:
Name:
University of Oklahoma; Stephenson Oklahoma Canc Ctr
Address:
City:
Oklahoma City
Zip:
73104
Country:
United States
Status:
Recruiting
Facility:
Name:
Abramson Cancer Center; Univ of Pennsylvania
Address:
City:
Philadelphia
Zip:
19104
Country:
United States
Status:
Recruiting
Facility:
Name:
UPMC - Hillman Cancer Center
Address:
City:
Pittsburgh
Zip:
15232
Country:
United States
Status:
Recruiting
Facility:
Name:
St Vincent's Hospital Sydney
Address:
City:
Darlinghurst
Zip:
2010
Country:
Australia
Status:
Recruiting
Facility:
Name:
Slade Health Inward goods
Address:
City:
Mount Kuring-gai
Zip:
2080
Country:
Australia
Status:
Recruiting
Facility:
Name:
Alfred Health
Address:
City:
Melbourne
Zip:
3004
Country:
Australia
Status:
Recruiting
Facility:
Name:
Peter MacCallum Cancer Center
Address:
City:
North Melbourne
Zip:
3051
Country:
Australia
Status:
Recruiting
Facility:
Name:
Linear Clinical Research Limited
Address:
City:
Nedlands
Zip:
6009
Country:
Australia
Status:
Recruiting
Facility:
Name:
UZ Antwerpen
Address:
City:
Edegem
Zip:
2650
Country:
Belgium
Status:
Recruiting
Facility:
Name:
CHU de Liège
Address:
City:
Liège
Zip:
4000
Country:
Belgium
Status:
Recruiting
Facility:
Name:
AZ St Maarten Campus Leopoldstr
Address:
City:
Mechelen
Zip:
2800
Country:
Belgium
Status:
Active, not recruiting
Facility:
Name:
Santa Casa de Misericordia de Belo Horizonte - PPDS
Address:
City:
Belo Horizonte
Zip:
30150-221
Country:
Brazil
Status:
Recruiting
Facility:
Name:
Hospital de Clinicas de Porto Alegre HCPA PPDS
Address:
City:
Porto Alegre
Zip:
90035-903
Country:
Brazil
Status:
Recruiting
Facility:
Name:
Hospital Erasto Gaertner
Address:
City:
Curitiba
Zip:
81520-060
Country:
Brazil
Status:
Terminated
Facility:
Name:
Instituto Nacional de Câncer
Address:
City:
Rio de Janeiro
Zip:
20230-130
Country:
Brazil
Status:
Recruiting
Facility:
Name:
Universidade de Caxias do Sul
Address:
City:
Caxias Do Sul
Zip:
95070-561
Country:
Brazil
Status:
Recruiting
Facility:
Name:
Hospital Sao Lucas Da Pontificia Universidade Catolica Do Rio Grande Do Sul (PUCRS)
Address:
City:
Porto Alegre
Zip:
90610-000
Country:
Brazil
Status:
Recruiting
Facility:
Name:
Hospital de Cancer de Barretos
Address:
City:
Barretos
Zip:
14784-400
Country:
Brazil
Status:
Recruiting
Facility:
Name:
Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto Hospital de Base - PPDS
Address:
City:
Sao Jose Do Rio Preto
Zip:
15090-000
Country:
Brazil
Status:
Recruiting
Facility:
Name:
Instituto do Cancer do Estado de Sao Paulo - ICESP
Address:
City:
Sao Paulo
Zip:
01246-000
Country:
Brazil
Status:
Withdrawn
Facility:
Name:
Ottawa Hospital
Address:
City:
Ottawa
Zip:
K1H 8L6
Country:
Canada
Status:
Recruiting
Facility:
Name:
Princess Margaret Cancer Centre
Address:
City:
Toronto
Zip:
M5G 1Z5
Country:
Canada
Status:
Recruiting
Facility:
Name:
Jewish General Hospital; Sir Mortimer B. Davis
Address:
City:
Montreal
Zip:
H2W 1S6
Country:
Canada
Status:
Recruiting
Facility:
Name:
Universitätsklinikum "Carl Gustav Carus" der Technischen Universität Dresden
Address:
City:
Dresden
Zip:
01307
Country:
Germany
Status:
Withdrawn
Facility:
Name:
Semmelweis Egyetem; Belgyogyaszati es Hematologiai Klinika
Address:
City:
Budapest
Zip:
1088
Country:
Hungary
Status:
Withdrawn
Facility:
Name:
Clinexpert Gyongyos Kft
Address:
City:
Gyöngyös
Zip:
3200
Country:
Hungary
Status:
Suspended
Facility:
Name:
Rambam Medical Center
Address:
City:
Haifa
Zip:
3109601
Country:
Israel
Status:
Recruiting
Facility:
Name:
Sheba Medical Center - PPDS
Address:
City:
Ramat Gan
Zip:
5266202
Country:
Israel
Status:
Recruiting
Facility:
Name:
Tel-Aviv Sourasky Medical Center
Address:
City:
Tel Aviv
Zip:
6423906
Country:
Israel
Status:
Recruiting
Facility:
Name:
Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori IRST - PPDS
Address:
City:
Meldola
Zip:
47014
Country:
Italy
Status:
Completed
Facility:
Name:
Irccs Ospedale San Raffaele;Oncologia Medica
Address:
City:
Milano
Zip:
20132
Country:
Italy
Status:
Recruiting
Facility:
Name:
Asst Grande Ospedale Metropolitano Niguarda
Address:
City:
Milano
Zip:
20162
Country:
Italy
Status:
Completed
Facility:
Name:
Istituto Clinico Humanitas
Address:
City:
Rozzano (MI)
Zip:
20089
Country:
Italy
Status:
Recruiting
Facility:
Name:
Azienda Ospedaliero Universitaria Pisana
Address:
City:
Pisa
Zip:
56126
Country:
Italy
Status:
Active, not recruiting
Facility:
Name:
Aga Khan University Hospital
Address:
City:
Nairobi
Zip:
00100
Country:
Kenya
Status:
Recruiting
Facility:
Name:
Seoul National University Bundang Hospital
Address:
City:
Seongnam-si
Zip:
463-707
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Seoul National University Hospital
Address:
City:
Seoul
Zip:
03080
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Asan Medical Center - PPDS
Address:
City:
Seoul
Zip:
05505
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Samsung Medical Center - PPDS
Address:
City:
Seoul
Zip:
06351
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Het Nederlands Kanker Instituut Antoni Van Leeuwenhoek Ziekenhuis
Address:
City:
Amsterdam
Zip:
1066 CX
Country:
Netherlands
Status:
Recruiting
Facility:
Name:
Leids Universitair Medisch Centrum
Address:
City:
Leiden
Zip:
2333 ZA
Country:
Netherlands
Status:
Active, not recruiting
Facility:
Name:
Maastricht University Medical Center
Address:
City:
Maastricht
Zip:
6229 HX
Country:
Netherlands
Status:
Recruiting
Facility:
Name:
Universitair Medisch Centrum Utrecht
Address:
City:
Utrecht
Zip:
3584 CX
Country:
Netherlands
Status:
Recruiting
Facility:
Name:
Auckland City Hospital, Cancer and Blood Research
Address:
City:
Auckland
Zip:
1023
Country:
New Zealand
Status:
Recruiting
Facility:
Name:
Auckland City Hospital
Address:
City:
Auckland
Zip:
1023
Country:
New Zealand
Status:
Recruiting
Facility:
Name:
New Zealand Clinical Research - Christchurch
Address:
City:
Christchurch
Zip:
8011
Country:
New Zealand
Status:
Recruiting
Facility:
Name:
Haukeland University Hospital; Hospital Pharmacy
Address:
City:
Bergen
Zip:
5053
Country:
Norway
Status:
Recruiting
Facility:
Name:
Oslo university hospital Radiumhospitalet
Address:
City:
Oslo
Zip:
0424
Country:
Norway
Status:
Recruiting
Facility:
Name:
Medical University of Gdansk
Address:
City:
Gdansk
Zip:
80-952
Country:
Poland
Status:
Recruiting
Facility:
Name:
Biokinetica, Przychodnia Jozefow
Address:
City:
Jozefow
Zip:
05-410
Country:
Poland
Status:
Recruiting
Facility:
Name:
Uniwersytecki Szpital Kliniczny w Poznaniu
Address:
City:
Pozna?
Zip:
60-780
Country:
Poland
Status:
Withdrawn
Facility:
Name:
Republican Clinical Oncology Dispensary of Ministry of Healthcare of Tatarstan Republic
Address:
City:
Kazan
Zip:
420029
Country:
Russian Federation
Status:
Withdrawn
Facility:
Name:
Hospital Universitari Vall d'Hebron
Address:
City:
Barcelona
Zip:
08035
Country:
Spain
Status:
Recruiting
Facility:
Name:
START Madrid-FJD, Hospital Fundacion Jimenez Diaz
Address:
City:
Madrid
Zip:
28040
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital Universitario 12 de Octubre
Address:
City:
Madrid
Zip:
28041
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital Universitario HM Sanchinarro-CIOCC
Address:
City:
Madrid
Zip:
28050
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital Clinico Universitario Virgen de la Victoria
Address:
City:
Malaga
Zip:
29010
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital Universitario Virgen del Rocío
Address:
City:
Sevilla
Zip:
41013
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital Clinico Universitario de Valencia
Address:
City:
Valencia
Zip:
46010
Country:
Spain
Status:
Recruiting
Facility:
Name:
Universitaetsspital Basel; Onkologie
Address:
City:
Basel
Zip:
4031
Country:
Switzerland
Status:
Withdrawn
Facility:
Name:
Inselspital
Address:
City:
Bern
Zip:
3010
Country:
Switzerland
Status:
Recruiting
Facility:
Name:
Hôpitaux Universitaires de Genève
Address:
City:
Genève
Zip:
1211
Country:
Switzerland
Status:
Recruiting
Facility:
Name:
Unversitätsspital Zürich
Address:
City:
Zürich
Zip:
8091
Country:
Switzerland
Status:
Withdrawn
Facility:
Name:
Queen Elizabeth Hospital
Address:
City:
Birmingham
Zip:
B15 2TH
Country:
United Kingdom
Status:
Recruiting
Facility:
Name:
Velindre Cancer Centre
Address:
City:
Cardiff
Zip:
CF14 2TL
Country:
United Kingdom
Status:
Recruiting
Facility:
Name:
University College London Hospitals NHS Foundation Trust; NIHR UCLH Clinical Research Facility
Address:
City:
London
Zip:
W1T 7HA
Country:
United Kingdom
Status:
Recruiting
Facility:
Name:
The Christie NHS Foundation Trust
Address:
City:
Manchester
Zip:
M20 4BX
Country:
United Kingdom
Status:
Recruiting
Start date:
July 29, 2020
Completion date:
November 30, 2024
Lead sponsor:
Agency:
Genentech, Inc.
Agency class:
Industry
Source:
Genentech, Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT04449874
