Sotorasib Activity in Subjects With Advanced Solid Tumors With KRAS p.G12C Mutation (CodeBreak 101)

Summary

To evaluate the safety and tolerability of sotorasib administered in investigational regimens in adult participants with KRAS p.G12C mutant advanced solid tumors.

Conditions

• Advanced Solid Tumors
• Kirsten Rat Sarcoma (KRAS) pG12C Mutation

Interventions

DRUG

Sotorasib

Sotorasib administered orally as a tablet.

DRUG

Trametinib

Trametinib administered orally as a tablet.

DRUG

RMC-4630

RMC-4630 administered orally as a capsule.

DRUG

Afatinib

afatinib administered orally as a tablet.

DRUG

Pembrolizumab

pembrolizumab administered as an intravenous (IV) infusion.

DRUG

Panitumumab

Panitumumab administered as an IV infusion.

DRUG

Carboplatin, pemetrexed, docetaxel, paclitaxel

Carboplatin, pemetrexed, docetaxel administered as an IV infusion.

DRUG

Atezolizumab

Atezolizumab administered as an IV injection.

DRUG

Palbociclib

Palbociclib administered orally as a tablet.

DRUG

MVASI® (bevacizumab-awwb)

MVASI® (bevacizumab-awwb) administered as an IV infusion.

DRUG

TNO155

TNO155 administered orally as a capsule.

DRUG

IV Chemotherapy (Regimen 1)

Chemotherapy combination of leucovorin administered as an IV injection, 5-fluorouracil (5-FU) administered as IV bolus injection or IV continuous infusion (depending on dose), and irinotecan administered as IV injection.

DRUG

IV Chemotherapy (Regimen 2)

IV chemotherapy combination of leucovorin administered as an IV injection, 5-FU administered as IV bolus injection or IV continuous infusion (depending on dose), and oxaliplatin administered as IV injection.

DRUG

BI 1701963

BI 1701963 administered orally

DRUG

AMG 404

AMG 404 administered as an IV infusion.

DRUG

Everolimus

Everolimus administered orally.

Sponsors & Collaborators

• Amgen

  lead INDUSTRY

Principal Investigators

• MD · Amgen

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

SEQUENTIAL

Eligibility

Min Age

18 Years

Max Age

100 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-12-17

Primary Completion

2026-12-17

Completion

2027-12-05

FDA Drug

Yes

Countries

• United States
• Australia
• Austria
• Belgium
• Canada
• Germany
• Italy
• Japan
• Netherlands
• South Korea
• Spain
• Taiwan
• United Kingdom

Study Locations