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

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

Sponsors

Lead Sponsor: Genentech, Inc.

Source 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.

Overall Status Not yet recruiting
Start Date July 1, 2020
Completion Date August 31, 2023
Primary Completion Date August 31, 2023
Phase Phase 1
Study Type Interventional
Primary Outcome
Measure Time Frame
Percentage of Participants With Adverse Events (AEs) From baseline up until 28 days after the final dose
Percentage of Participants With Dose-Limiting Toxicities (DLTs) Days 1-21 of Cycle 1 (a cycle is 21 days)
Percentage of Participants With Changes From Baseline in Targeted Vital Signs From baseline up until 28 days after the final dose
Percentage of Participants With Changes From Baseline in Targeted Clinical Laboratory Test Results From baseline up until 28 days after the final dose
Percentage of Participants With Changes From Baseline in Targeted ECG Parameters From baseline up until 28 days after the final dose
Secondary Outcome
Measure Time Frame
Plasma Concentration of GDC-6036 From baseline up until 28 days after the final dose or at study treatment discontinuation visit
Objective Response Rate (ORR) as Determined by the Investigator According to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1) Up to 42 months
Duration of Response (DOR) as Determined by the Investigator According to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1) Up to 42 months
Progression-free survival (PFS) as determined by the investigator according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1) Up to 42 months
Enrollment 108
Condition
Intervention

Intervention Type: Drug

Intervention Name: GDC-6036

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

Arm Group Label: Dose-escalation (Stage I), Dose Expansion (Stage II)

Eligibility

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

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Clinical Trials Study Director Hoffmann-La Roche
Overall Contact

Last Name: Reference Study ID Number: GO42144 www.roche.com/about_roche/roche_worldwide.htm

Phone: 888-662-6728 (U.S. and Canada)

Email: [email protected]

Location
Facility:
City of Hope Comprehensive Cancer Center | Duarte, California, 91010, United States
Yale Cancer Center | New Haven, Connecticut, 06520, United States
Florida Cancer Specialists - Sarasota | Sarasota, Florida, 34232, United States
Dana Farber Cancer Institute | Boston, Massachusetts, 02215, United States
Memorial Sloan Kettering Cancer Center | New York, New York, 10065, United States
Peter MacCallum Cancer Center | Melbourne, Victoria, 3000, Australia
Princess Margaret Cancer Centre | Toronto, Ontario, M5G 2C1, Canada
Jewish General Hospital; Sir Mortimer B. Davis | Montreal, Quebec, H2W 1S6, Canada
Location Countries

Australia

Canada

United States

Verification Date

June 2020

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Label: Dose-escalation (Stage I), Dose Expansion (Stage II)

Type: Experimental

Description: 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.

Patient Data No
Study Design Info

Intervention Model: Sequential Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov