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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04449874




Registration number
NCT04449874
Ethics application status
Date submitted
24/06/2020
Date registered
29/06/2020

Titles & IDs
Public 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
Scientific title
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
Secondary ID [1] 0 0
2020-000084-22
Secondary ID [2] 0 0
GO42144
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-Small Cell Lung Cancer 0 0
Colorectal Cancer 0 0
Advanced Solid Tumors 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Bowel - Back passage (rectum) or large bowel (colon)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - GDC-6036
Treatment: Drugs - Atezolizumab
Treatment: Drugs - Cetuximab
Treatment: Drugs - Bevacizumab
Treatment: Drugs - Erlotinib
Treatment: Drugs - GDC-1971
Treatment: Drugs - Inavolisib

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.


Treatment: Drugs: 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).

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

Treatment: Drugs: 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.

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

Treatment: Drugs: Erlotinib
150 mg of erlotinib will be administered PO QD in 21 day cycles.

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

Treatment: Drugs: Inavolisib
The starting dose of inavolisib will be determined from its single-agent dose escalation.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants With Adverse Events (AEs)
Timepoint [1] 0 0
From Cycle 1 Day 1 until 28 days after the final dose (or as specified in the protocol). A cycle is 21 days.
Primary outcome [2] 0 0
Percentage of Participants With Dose-Limiting Toxicities (DLTs)
Timepoint [2] 0 0
From Cycle 1 Day 1 through Day 21. A cycle is 21 days.
Secondary outcome [1] 0 0
Plasma Concentrations of GDC-6036
Timepoint [1] 0 0
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.
Secondary outcome [2] 0 0
Plasma Concentrations of Erlotinib
Timepoint [2] 0 0
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.
Secondary outcome [3] 0 0
Plasma Concentrations of GDC-1971
Timepoint [3] 0 0
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.
Secondary outcome [4] 0 0
Plasma Concentrations of Inavolisib
Timepoint [4] 0 0
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.
Secondary outcome [5] 0 0
Objective Response Rate (ORR) as Determined by the Investigator According to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)
Timepoint [5] 0 0
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.
Secondary outcome [6] 0 0
Duration of Response (DOR) as Determined by the Investigator According to RECIST v1.1
Timepoint [6] 0 0
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.
Secondary outcome [7] 0 0
Progression-free survival (PFS) as determined by the investigator according to RECIST v1.1
Timepoint [7] 0 0
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.
Secondary outcome [8] 0 0
Relationship Between GDC-6036 Exposure (Maximum Plasma Concentration Observed [Cmax])
Timepoint [8] 0 0
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.
Secondary outcome [9] 0 0
Relationship Between GDC-6036 Exposure (Time to Maximum Plasma Concentration [Tmax])
Timepoint [9] 0 0
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.
Secondary outcome [10] 0 0
Relationship Between GDC-6036 Exposure (Half-life [t1/2])
Timepoint [10] 0 0
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.
Secondary outcome [11] 0 0
Relationship Between GDC-6036 Exposure (Area Under the Curve [AUC])
Timepoint [11] 0 0
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.
Secondary outcome [12] 0 0
Relationship Between Tumor Pharmacodynamic Effects of GDC-6036
Timepoint [12] 0 0
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.

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Active brain metastases.
* Malabsorption or other condition that interferes with enteral absorption.
* Clinically significant cardiovascular dysfunction or liver disease.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
29/07/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/03/2026
Actual
Sample size
Target
498
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC,WA
Recruitment hospital [1] 0 0
St Vincent's Hospital Sydney - Darlinghurst
Recruitment hospital [2] 0 0
Slade Health Inward goods - Mount Kuring-gai
Recruitment hospital [3] 0 0
Alfred Health - Melbourne
Recruitment hospital [4] 0 0
Peter MacCallum Cancer Center - North Melbourne
Recruitment hospital [5] 0 0
Linear Clinical Research Limited - Nedlands
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
2080 - Mount Kuring-gai
Recruitment postcode(s) [3] 0 0
3004 - Melbourne
Recruitment postcode(s) [4] 0 0
3051 - North Melbourne
Recruitment postcode(s) [5] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Connecticut
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Massachusetts
Country [5] 0 0
United States of America
State/province [5] 0 0
New York
Country [6] 0 0
United States of America
State/province [6] 0 0
Oklahoma
Country [7] 0 0
United States of America
State/province [7] 0 0
Pennsylvania
Country [8] 0 0
Belgium
State/province [8] 0 0
Edegem
Country [9] 0 0
Belgium
State/province [9] 0 0
Liège
Country [10] 0 0
Belgium
State/province [10] 0 0
Mechelen
Country [11] 0 0
Brazil
State/province [11] 0 0
MG
Country [12] 0 0
Brazil
State/province [12] 0 0
PA
Country [13] 0 0
Brazil
State/province [13] 0 0
PR
Country [14] 0 0
Brazil
State/province [14] 0 0
RJ
Country [15] 0 0
Brazil
State/province [15] 0 0
RS
Country [16] 0 0
Brazil
State/province [16] 0 0
SP
Country [17] 0 0
Canada
State/province [17] 0 0
Ontario
Country [18] 0 0
Canada
State/province [18] 0 0
Quebec
Country [19] 0 0
Germany
State/province [19] 0 0
Dresden
Country [20] 0 0
Hungary
State/province [20] 0 0
Budapest
Country [21] 0 0
Hungary
State/province [21] 0 0
Gyöngyös
Country [22] 0 0
Israel
State/province [22] 0 0
Haifa
Country [23] 0 0
Israel
State/province [23] 0 0
Ramat Gan
Country [24] 0 0
Israel
State/province [24] 0 0
Tel Aviv
Country [25] 0 0
Italy
State/province [25] 0 0
Emilia-Romagna
Country [26] 0 0
Italy
State/province [26] 0 0
Lombardia
Country [27] 0 0
Italy
State/province [27] 0 0
Toscana
Country [28] 0 0
Kenya
State/province [28] 0 0
Nairobi
Country [29] 0 0
Korea, Republic of
State/province [29] 0 0
Seongnam-si
Country [30] 0 0
Korea, Republic of
State/province [30] 0 0
Seoul
Country [31] 0 0
Netherlands
State/province [31] 0 0
Amsterdam
Country [32] 0 0
Netherlands
State/province [32] 0 0
Leiden
Country [33] 0 0
Netherlands
State/province [33] 0 0
Maastricht
Country [34] 0 0
Netherlands
State/province [34] 0 0
Utrecht
Country [35] 0 0
New Zealand
State/province [35] 0 0
Auckland
Country [36] 0 0
New Zealand
State/province [36] 0 0
Christchurch
Country [37] 0 0
Norway
State/province [37] 0 0
Bergen
Country [38] 0 0
Norway
State/province [38] 0 0
Oslo
Country [39] 0 0
Poland
State/province [39] 0 0
Gdansk
Country [40] 0 0
Poland
State/province [40] 0 0
Jozefow
Country [41] 0 0
Poland
State/province [41] 0 0
Pozna?
Country [42] 0 0
Russian Federation
State/province [42] 0 0
Tatarstan
Country [43] 0 0
Spain
State/province [43] 0 0
Barcelona
Country [44] 0 0
Spain
State/province [44] 0 0
Madrid
Country [45] 0 0
Spain
State/province [45] 0 0
Malaga
Country [46] 0 0
Spain
State/province [46] 0 0
Sevilla
Country [47] 0 0
Spain
State/province [47] 0 0
Valencia
Country [48] 0 0
Switzerland
State/province [48] 0 0
Basel
Country [49] 0 0
Switzerland
State/province [49] 0 0
Bern
Country [50] 0 0
Switzerland
State/province [50] 0 0
Genève
Country [51] 0 0
Switzerland
State/province [51] 0 0
Zürich
Country [52] 0 0
United Kingdom
State/province [52] 0 0
Birmingham
Country [53] 0 0
United Kingdom
State/province [53] 0 0
Cardiff
Country [54] 0 0
United Kingdom
State/province [54] 0 0
London
Country [55] 0 0
United Kingdom
State/province [55] 0 0
Manchester

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Genentech, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Genentech, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Reference Study ID Number: GO42144 whttps://forpatients.roche.com/
Address 0 0
Country 0 0
Phone 0 0
888-662-6728 (U.S. and Canada)
Fax 0 0
Email 0 0
global-roche-genentech-trials@gene.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/members/ourmembers/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04449874