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

PHASE1Active, not recruitingINTERVENTIONAL
Enrollment

498

Participants

Timeline

Start Date

July 29, 2020

Primary Completion Date

September 24, 2026

Study Completion Date

September 24, 2026

Conditions
Non-Small Cell Lung CancerColorectal CancerAdvanced Solid Tumors
Interventions
DRUG

GDC-6036

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).

DRUG

Atezolizumab

A 1200 milligram (mg) intravenous (IV) infusion of atezolizumab will be administered on Day 1 of 21 day cycles.

DRUG

Cetuximab

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.

DRUG

Bevacizumab

A 15 milligram per kilogram (mg/kg) IV infusion of bevacizumab will be administered on Day 1 of 21 day cycles.

DRUG

Erlotinib

150 mg of erlotinib will be administered PO QD in 21 day cycles.

DRUG

GDC-1971

The starting dose of GDC-1971 will be determined from its single-agent dose escalation.

DRUG

Inavolisib

The starting dose of inavolisib will be determined from its single-agent dose escalation.

Trial Locations (67)

1023

Auckland City Hospital, Cancer and Blood Research, Auckland

1211

Hôpitaux Universitaires de Genève, Geneva

2010

St Vincent's Hospital Sydney, Darlinghurst

2080

Slade Health Inward goods, Mount Kuring-Gai

2650

UZ Antwerpen, Edegem

2800

AZ St Maarten Campus Leopoldstr, Mechelen

3000

Peter MacCallum Cancer Center, Melbourne

3004

Alfred Health, Melbourne

3010

Inselspital, Bern

3200

Clinexpert Gyongyos Kft, Gyöngyös

4000

CHU de Liège, Liège

5020

Haukeland University Hospital, Bergen

6009

Linear Clinical Research Limited, Nedlands

10021

Memorial Sloan Kettering Cancer Center, New York

13605

Seoul National University Bundang Hospital, Seongnam-si

15232

UPMC - Hillman Cancer Center, Pittsburgh

19104

Abramson Cancer Center, Philadelphia

20089

Istituto Clinico Humanitas, Rozzano (MI)

20132

Irccs Ospedale San Raffaele, Milan

20162

Asst Grande Ospedale Metropolitano Niguarda, Milan

28040

START Madrid-FJD, Hospital Fundacion Jimenez Diaz, Madrid

28041

Hospital Universitario 12 de Octubre, Madrid

28050

Hospital Universitario HM Sanchinarro-CIOCC, Madrid

29010

Hospital Clinico Universitario Virgen de la Victoria, Málaga

34232

Florida Cancer Specialists - Sarasota, Sarasota

41013

Hospital Universitario Virgen del Rocío, Seville

46010

Hospital Clinico Universitario de Valencia, Valencia

47014

Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori IRST - PPDS, Meldola

52621

Sheba Medical Center - PPDS, Ramat Gan

56100

Azienda Ospedaliero Universitaria Pisana, Pisa

73104

University of Oklahoma, Oklahoma City

91010

City of Hope Comprehensive Cancer Center, Duarte

92093

UCSD Moores Cancer Center, La Jolla

92868

Chao Family Comprehensive Cancer Center UCI, Orange

3109601

Rambam Medical Center, Haifa

6423906

Tel-Aviv Sourasky Medical Center, Tel Aviv

06511

Yale Cancer Center, New Haven

02215

Dana Farber Cancer Institute, Boston

30150-221

Santa Casa de Misericordia de Belo Horizonte - PPDS, Belo Horizonte

81520-060

Hospital Erasto Gaertner, Curitiba

90035-903

Hospital de Clinicas de Porto Alegre HCPA PPDS, Pôrto Alegre

95070-561

Universidade de Caxias do Sul, Caxias do Sul

90610-000

Hospital Sao Lucas Da Pontificia Universidade Catolica Do Rio Grande Do Sul (PUCRS), Porto Alegre

14784-400

Hospital de Cancer de Barretos, Barretos

15090-000

Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto Hospital de Base - PPDS, São José do Rio Preto

20230-130

Instituto Nacional de Câncer, Rio de Janeiro

K1H 8L6

Ottawa Hospital, Ottawa

M5G 2M9

Princess Margaret Cancer Centre, Toronto

H3T 1E2

Jewish General Hospital, Montreal

00100

Aga Khan University Hospital, Nairobi

1066 CX

Het Nederlands Kanker Instituut Antoni Van Leeuwenhoek Ziekenhuis, Amsterdam

2333 ZA

Leids Universitair Medisch Centrum, Leiden

6229 HX

Maastricht University Medical Center, Maastricht

3584 CX

Universitair Medisch Centrum Utrecht, Utrecht

Unknown

Auckland City Hospital, Auckland

New Zealand Clinical Research - Christchurch, Christchurch

0424

Oslo university hospital Radiumhospitalet, Oslo

80-214

Uniwersyteckie Centrum Kliniczne, O?rodek Bada? Klinicznych Wczesnych Faz, Gdansk

05-410

Biokinetica, Przychodnia Jozefow, Józefów

03080

Seoul National University Hospital, Seoul

05505

Asan Medical Center - PPDS, Seoul

06351

Samsung Medical Center - PPDS, Seoul

08035

Hospital Universitari Vall d'Hebron, Barcelona

B15 2GW

Queen Elizabeth Hospital, Birmingham

CF14 2TL

Velindre Cancer Centre, Cardiff

W1T 7HA

University College London Hospitals NHS Foundation Trust, London

M20 4BX

The Christie NHS Foundation Trust, Manchester

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Genentech, Inc.

INDUSTRY

NCT04449874 - 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 | Biotech Hunter | Biotech Hunter