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JOURNAL ONKOLOGIE – STUDIE

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

Rekrutierend

NCT-Nummer:
NCT04449874

Studienbeginn:
Juli 2020

Letztes Update:
25.01.2021

Wirkstoff:
GDC-6036, Atezolizumab, Cetuximab, Bevacizumab, Erlotinib

Indikation (Clinical Trials):
Carcinoma, Non-Small-Cell Lung, Colorectal Neoplasms

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 1

Sponsor:
Genentech, Inc.

Collaborator:
-

Studienleiter

Clinical Trials
Study Director
Hoffmann-La Roche

Kontakt

Reference Study ID Number: GO42144 www.roche.com/about_roche/roche_worldwide.htm
Kontakt:
Phone: 888-662-6728 (U.S. and Canada)
E-Mail: global-roche-genentech-trials@gene.com» Kontaktdaten anzeigen

Studienlocations
(3 von 70)

Universitätsklinikum "Carl Gustav Carus" der Technischen Universität Dresden
01307 Dresden
(Sachsen)
GermanyNoch nicht rekrutierend» Google-Maps
Clinical Research Center (CRC) Hannover
30625 Hannover
(Niedersachsen)
GermanyNoch nicht rekrutierend» Google-Maps
Lungenfachklinik Immenhausen
34376 Immenhausen
(Hessen)
GermanyNoch nicht rekrutierend» Google-Maps
Lungenkrebszentrum Uniklinik Köln / Solingen
Kerpener Straße 62
50937 Köln
DeutschlandNoch nicht rekrutierend» Google-Maps
City of Hope Comprehensive Cancer Center
91010 Duarte
United StatesRekrutierend» Google-Maps
UCSD Moores Cancer Center
92093 La Jolla
United StatesNoch nicht rekrutierend» Google-Maps
Univ of Calif, San Francisco; Breast Cancer Center
94115 San Francisco
United StatesNoch nicht rekrutierend» Google-Maps
Florida Cancer Specialists - Sarasota
34232 Sarasota
United StatesRekrutierend» Google-Maps
Rush University Medical Center - PPDS
60612 Chicago
United StatesNoch nicht rekrutierend» Google-Maps
University of Chicago
60637 Chicago
United StatesNoch nicht rekrutierend» Google-Maps
Dana Farber Cancer Institute
02215 Boston
United StatesRekrutierend» Google-Maps
Memorial Sloan Kettering Cancer Center
10065 New York
United StatesNoch nicht rekrutierend» Google-Maps
UPMC - Hillman Cancer Center
15232 Pittsburgh
United StatesNoch nicht rekrutierend» Google-Maps
St Vincent's Hospital Sydney
2010 Darlinghurst
AustraliaNoch nicht rekrutierend» Google-Maps
Peter MacCallum Cancer Center
3002 East Melbourne
AustraliaRekrutierend» Google-Maps
Linear Clinical Research Limited
6009 Nedlands
AustraliaNoch nicht rekrutierend» Google-Maps
AZ St Maarten Campus Leopoldstr
2800 Mechelen
BelgiumNoch nicht rekrutierend» Google-Maps
London Health Sciences Centre; University Hospital;RESEARH PHARMACY
N6A 5A5 London
CanadaNoch nicht rekrutierend» Google-Maps
Princess Margaret Cancer Centre
M5G 2M9 Toronto
CanadaRekrutierend» Google-Maps
Jewish General Hospital; Sir Mortimer B. Davis
H2W 1S6 Montreal
CanadaRekrutierend» Google-Maps
Centre Georges Francois Leclerc
21000 Dijon
FranceNoch nicht rekrutierend» Google-Maps
CIC-CPCET; CIC - CPCET - Batiment F - 1er étage
13385 Marseille
FranceNoch nicht rekrutierend» Google-Maps
Centre Eugene Marquis Centre Regional de Lutte Contre Le Cancer
35000 Rennes
FranceNoch nicht rekrutierend» Google-Maps
EDOG - Institut Claudius Regaud - PPDS
31000 Toulouse
FranceNoch nicht rekrutierend» Google-Maps
Institut Gustave Roussy; Departement Oncologie Medicale
94805 Villejuif
FranceNoch nicht rekrutierend» Google-Maps
Rambam Medical Center
3109601 Haifa
IsraelNoch nicht rekrutierend» Google-Maps
Sheba Medical Center - PPDS
52621 Ramat Gan
IsraelNoch nicht rekrutierend» Google-Maps
Tel-Aviv Sourasky Medical Center
6423906 Tel Aviv
IsraelNoch nicht rekrutierend» Google-Maps
Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori IRST - PPDS
47014 Meldola
ItalyNoch nicht rekrutierend» Google-Maps
Irccs Ospedale San Raffaele;Oncologia Medica
20132 Milano
ItalyNoch nicht rekrutierend» Google-Maps
Asst Grande Ospedale Metropolitano Niguarda
20162 Milano
ItalyNoch nicht rekrutierend» Google-Maps
Istituto Clinico Humanitas
20089 Rozzano (MI)
ItalyNoch nicht rekrutierend» Google-Maps
Azienda Ospedaliero Universitaria Pisana
56100 Pisa
ItalyNoch nicht rekrutierend» Google-Maps
Seoul National University Bundang Hospital
13605 Seongnam-si
Korea, Republic ofNoch nicht rekrutierend» Google-Maps
Seoul National University Hospital
03080 Seoul
Korea, Republic ofNoch nicht rekrutierend» Google-Maps
Asan Medical Center - PPDS
05505 Seoul
Korea, Republic ofNoch nicht rekrutierend» Google-Maps
Samsung Medical Center - PPDS
06351 Seoul
Korea, Republic ofNoch nicht rekrutierend» Google-Maps
Het Nederlands Kanker Instituut Antoni Van Leeuwenhoek Ziekenhuis
1066 CX Amsterdam
NetherlandsNoch nicht rekrutierend» Google-Maps
Leids Universitair Medisch Centrum
2333 ZA Leiden
NetherlandsNoch nicht rekrutierend» Google-Maps
Maastricht University Medical Center
6229 HX Maastricht
NetherlandsNoch nicht rekrutierend» Google-Maps
Erasmus MC
3015 GD Rotterdam
NetherlandsNoch nicht rekrutierend» Google-Maps
Universitair Medisch Centrum Utrecht
3584 CX Utrecht
NetherlandsNoch nicht rekrutierend» Google-Maps
Auckland City Hospital
1023 Auckland
New ZealandNoch nicht rekrutierend» Google-Maps
Christchurch Clinical Studies Trust Ltd
8011 Christchurch
New ZealandNoch nicht rekrutierend» Google-Maps
Medical University of Gdansk
80-952 Gdansk
PolandNoch nicht rekrutierend» Google-Maps
Biokinetica, Przychodnia Jozefow
05-410 Jozefow
PolandNoch nicht rekrutierend» Google-Maps
Szpital Kliniczny im. Heliodora Święcickiego UM w Poznaniu.
60-780 Poznań
PolandNoch nicht rekrutierend» Google-Maps
Russian Oncology Research Center n a N N Blokhin
115478 Moscow
Russian FederationNoch nicht rekrutierend» Google-Maps
Republican Clinical Oncology Dispensary of Ministry of Healthcare of Tatarstan Republic
420029 Kazan
Russian FederationNoch nicht rekrutierend» Google-Maps
Hospital Universitario Vall d'Hebron - PPDS
08035 Barcelona
SpainNoch nicht rekrutierend» Google-Maps
START Madrid-FJD, Hospital Fundacion Jimenez Diaz
28040 Madrid
SpainNoch nicht rekrutierend» Google-Maps
Hospital Universitario 12 de Octubre
28041 Madrid
SpainNoch nicht rekrutierend» Google-Maps
Hospital Universitario HM Sanchinarro-CIOCC
28050 Madrid
SpainNoch nicht rekrutierend» Google-Maps
Hospital Clinico Universitario Virgen de la Victoria
29010 Malaga
SpainNoch nicht rekrutierend» Google-Maps
Hospital Universitario Virgen del Rocío
41013 Sevilla
SpainNoch nicht rekrutierend» Google-Maps
Universitaetsspital Basel; Onkologie
4031 Basel
SwitzerlandNoch nicht rekrutierend» Google-Maps
Hôpitaux Universitaires de Genève
1211 Genève
SwitzerlandNoch nicht rekrutierend» Google-Maps
Unversitätsspital Zürich
8091 Zürich
SwitzerlandNoch nicht rekrutierend» Google-Maps
Queen Elizabeth Hospital
B15 2TH Birmingham
United KingdomNoch nicht rekrutierend» Google-Maps
Velindre Cancer Centre
CF14 2TL Cardiff
United KingdomNoch nicht rekrutierend» Google-Maps
University College London Hospital
NW1 - 2PG London
United KingdomNoch nicht rekrutierend» Google-Maps
Guys and St Thomas Hospital
SE1 9RT London
United KingdomNoch nicht rekrutierend» Google-Maps
The Christie NHS Foundation Trust
M20 4BX Manchester
United KingdomNoch nicht rekrutierend» Google-Maps
Alle anzeigen

Studien-Informationen

Brief 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.

Ein-/Ausschlusskriterien

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 as specified in the protocol.

- Men who are not surgically sterile must agree to remain abstinent or use

contraception, 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.

Studien-Rationale

Primary outcome:

1. Percentage of Participants With Adverse Events (AEs) (Time Frame - From Cycle 1 Day 1 until 28 days after the final dose (or as specified in the protocol). A cycle is 21 days.):
Severity is determined according to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE v5.0)

2. Percentage of Participants With Dose-Limiting Toxicities (DLTs) (Time Frame - From Cycle 1 Day 1 through Day 21. A cycle is 21 days.)

Secondary outcome:

1. Plasma Concentrations of GDC-6036 (Time Frame - Various timepoints from Cycle 1 Day 1 through study treatment discontinuation (within 28 days after the final dose of study drug). A cycle is 21 days.)

2. Plasma Concentrations of Erlotinib (Time Frame - Various timepoints from Cycle 1 Day 1 through study treatment discontinuation (within 28 days after the final dose of study drug). A cycle is 21 days.)

3. Serum Concentrations of Atezolizumab (Time Frame - Various timepoints from Cycle 1 Day 1 through study treatment discontinuation (within 28 days after the final dose of study drug). A cycle is 21 days.)

4. Serum Concentrations of Bevacizumab (Time Frame - Various timepoints from Cycle 1 Day 1 through study treatment discontinuation (within 28 days after the final dose of study drug). A cycle is 21 days.)

5. Serum Concentrations of Cetuximab (Time Frame - Various timepoints from Cycle 1 Day 1 through study treatment discontinuation (within 28 days after the final dose of study drug). A cycle is 21 days.)

6. Incidence of Anti-drug Antibodies (ADAs) to Atezolizumab during the study (Time Frame - Various timepoints from Cycle 1 Day 1 through study treatment discontinuation (within 28 days after the final dose of study drug). A cycle is 21 days.)

7. Incidence of ADAs to Bevacizumab during the study (Time Frame - Various timepoints from Cycle 1 Day 1 through study treatment discontinuation (within 28 days after the final dose of study drug). A cycle is 21 days.)

8. Incidence of ADAs to Cetuximab during the study (Time Frame - Various timepoints from Cycle 1 Day 1 through study treatment discontinuation (within 28 days after the final dose of study drug). A cycle is 21 days.)

9. Objective Response Rate (ORR) as Determined by the Investigator According to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1) (Time Frame - Every 6 weeks from Cycle 1 Day 1 until study treatment discontinuation (within 28 days after the final dose of study drug). A cycle is 21 days.)

10. Duration of Response (DOR) as Determined by the Investigator According to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1) (Time Frame - Every 6 weeks from Cycle 1 Day 1 until study treatment discontinuation (within 28 days after the final dose of study drug). A cycle is 21 days.)

11. Progression-free survival (PFS) as determined by the investigator according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1) (Time Frame - Every 6 weeks from Cycle 1 Day 1 until study treatment discontinuation (within 28 days after the final dose of study drug). A cycle is 21 days.)

12. Relationship Between GDC-6036 Exposure (Maximum Plasma Concentration Observed [Cmax]) (Time Frame - Various timepoints from Cycle 1 Day 1 through study treatment discontinuation (within 28 days after the final dose of study drug). A cycle is 21 days.)

13. Relationship Between GDC-6036 Exposure (Time to Maximum Plasma Concentration [Tmax]) (Time Frame - Various timepoints from Cycle 1 Day 1 through study treatment discontinuation (within 28 days after the final dose of study drug). A cycle is 21 days.)

14. Relationship Between GDC-6036 Exposure (Half-life [t1/2]) (Time Frame - Various timepoints from Cycle 1 Day 1 through study treatment discontinuation (within 28 days after the final dose of study drug). A cycle is 21 days.)

15. Relationship Between GDC-6036 Exposure (Area Under the Curve [AUC]) (Time Frame - Various timepoints from Cycle 1 Day 1 through study treatment discontinuation (within 28 days after the final dose of study drug). A cycle is 21 days.)

16. Relationship Between Tumor Pharmacodynamic Effects of GDC-6036 (Time Frame - Various timepoints from Cycle 1 Day 1 through study treatment discontinuation (within 28 days after the final dose of study drug). A cycle is 21 days.)

Studien-Arme

  • 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.

Geprüfte Regime

  • GDC-6036:
    The starting dose of GDC-6036 in the combination Arms B, C, D and E will be determined from Stage I Arm A (single-agent dose escalation).
  • Atezolizumab:
    A 1200 milligram (mg) intravenous (IV) infusion of atezolizumab will be administered on Day 1 of 21 day cycles.
  • 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.
  • Bevacizumab:
    A 15 milligram per kilogram (mg/kg) IV infusion of bevacizumab will be administered on Day 1 of 21 day cycles.
  • Erlotinib:
    150 mg of erlotinib will be administered PO QD in 21 day cycles.

Quelle: ClinicalTrials.gov


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