A Study Evaluating the Safety, Tolerability, and Pharmacokinetics of GDC-0973 in Combination With GDC-0068 When Administered in Participants With Locally Advanced or Metastatic Solid Tumors

Phase 1 Completed 67 enrolled Genentech, Inc.

Non-randomizedParallel-groupOpen-labelTreatment

Summary

This open-label, multicenter, Phase Ib dose-escalation study will evaluate the safety, tolerability and pharmacokinetics of oral dosing of GDC-0973 and GDC-0068 administered in combination in patients with locally advanced or metastatic solid tumors. Cohorts of patients will receive multiple ascending doses of GDC-0973 and GDC-0068. Anticipated time on study treatment is until disease progression or unacceptable toxicity occurs.

Timeline

Start: 2012-04
Primary completion: 2015-01
Completion: 2015-01

Publications

Shapiro GI, LoRusso P, Cho DC, Musib L, Yan Y, Wongchenko M, Chang I, Patel P, Chan IT, Sanabria-Bohorquez S, Meng RD, Bendell JC. A phase Ib open-label dose escalation study of the safety, pharmacokinetics, and pharmacodynamics of cobimetinib (GDC-0973) and ipatasertib (GDC-0068) in patients with locally advanced or metastatic solid tumors. Invest New Drugs. 2021 Feb;39(1):163-174. doi: 10.1007/s10637-020-00975-6. Epub 2020 Jul 31.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Cobimetinib	Small molecule	40 mg	Oral
Subject	Cobimetinib	Small molecule	60 mg	Oral
Subject	Cobimetinib	Small molecule	100 mg	Oral
Subject	Cobimetinib	Small molecule	150 mg	Oral
Subject	Ipatasertib	Small molecule	200 mg	Oral
Subject	Ipatasertib	Small molecule	300 mg	Oral

A Study Evaluating the Safety, Tolerability, and Pharmacokinetics of GDC-0973 in Combination With GDC-0068 When Administered in Participants With Locally Advanced or Metastatic Solid Tumors

Summary

Timeline

Publications

Drugs

Indications