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A Study to Evaluate the Safety, Pharmacokinetics, and Activity of GDC-6036 in Patients With Advanced or Metastatic Solid Tumors With a KRAS G12C Mutation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04449874
Recruitment Status : Recruiting
First Posted : June 29, 2020
Last Update Posted : September 24, 2020
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.

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.

Condition or disease Intervention/treatment Phase
Non-Small Cell Lung Cancer Colorectal Cancer Advanced Solid Tumors Drug: GDC-6036 Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 108 participants
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Dose-Escalation and Dose-Expansion Study Evaluating the Safety, Pharmacokinetics, and Activity of GDC-6036 in Patients With Advanced or Metastatic Solid Tumors With a KRAS G12C Mutation
Actual Study Start Date : July 29, 2020
Estimated Primary Completion Date : August 31, 2023
Estimated Study Completion Date : August 31, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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 safety threshold is observed.

Participants with select solid tumors will be treated with GDC-6036 PO QD in Stage II.

Drug: GDC-6036
Stage I and Stage II: GDC-6036 will be administered PO QD.




Primary Outcome Measures :
  1. Percentage of Participants With Adverse Events (AEs) [ Time Frame: From baseline up until 28 days after the final dose ]
  2. Percentage of Participants With Dose-Limiting Toxicities (DLTs) [ Time Frame: Days 1-21 of Cycle 1 (a cycle is 21 days) ]
  3. Percentage of Participants With Changes From Baseline in Targeted Vital Signs [ Time Frame: From baseline up until 28 days after the final dose ]
  4. Percentage of Participants With Changes From Baseline in Targeted Clinical Laboratory Test Results [ Time Frame: From baseline up until 28 days after the final dose ]
  5. Percentage of Participants With Changes From Baseline in Targeted ECG Parameters [ Time Frame: From baseline up until 28 days after the final dose ]

Secondary Outcome Measures :
  1. Plasma Concentration of GDC-6036 [ Time Frame: From baseline up until 28 days after the final dose or at study treatment discontinuation visit ]
  2. 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: Up to 42 months ]
  3. 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: Up to 42 months ]
  4. 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: Up to 42 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically documented advanced or metastatic solid tumor with KRAS G12C mutation.

Exclusion Criteria:

  • Active brain metastases
  • Malabsorption or other condition that interferes with enteral absorption
  • Clinically significant cardiovascular dysfunction or liver disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04449874


Contacts
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Contact: Reference Study ID Number: GO42144 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. and Canada) global-roche-genentech-trials@gene.com

Locations
Show Show 17 study locations
Sponsors and Collaborators
Genentech, Inc.
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche
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Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT04449874    
Other Study ID Numbers: GO42144
2020-000084-22 ( EudraCT Number )
First Posted: June 29, 2020    Key Record Dates
Last Update Posted: September 24, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: 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).

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Genentech, Inc.:
KRAS G12C
Non-Small Cell Lung Cancer
Colorectal Cancer
GDC-6036
Additional relevant MeSH terms:
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Carcinoma, Non-Small-Cell Lung
Colorectal Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases