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

Official 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 Tumours With a KRAS G12C Mutation

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 tumours with a KRAS G12C mutation.

Trial Description

Primary Outcome:

• Percentage of Participants With Adverse Events (AEs)
• Percentage of Participants With Dose-Limiting Toxicities (DLTs)

• Plasma Concentrations of GDC-6036
• Plasma Concentrations of Erlotinib
• Plasma Concentrations of GDC-1971
• Plasma Concentrations of Inavolisib
• Serum Concentrations of Atezolizumab
• Serum Concentrations of Bevacizumab
• Serum Concentrations of Cetuximab
• Objective Response Rate (ORR) as Determined by the Investigator According to Response Evaluation Criteria in Solid Tumours, Version 1.1 (RECIST v1.1)
• Duration of Response (DOR) as Determined by the Investigator According to Response Evaluation Criteria in Solid Tumours, Version 1.1 (RECIST v1.1)
• Progression-free survival (PFS) as determined by the investigator according to Response Evaluation Criteria in Solid Tumours, Version 1.1 (RECIST v1.1)
• Relationship Between GDC-6036 Exposure (Maximum Plasma Concentration Observed [Cmax])
• Relationship Between GDC-6036 Exposure (Time to Maximum Plasma Concentration [Tmax])
• Relationship Between GDC-6036 Exposure (Half-life [t1/2])
• Relationship Between GDC-6036 Exposure (Area Under the Curve [AUC])
• Relationship Between Tumour Pharmacodynamic Effects of GDC-6036

View this trial on ClinicalTrials.gov