Sotorasib + Panitumumab for Colorectal Cancer
(CodeBreak300 Trial)

Recruiting in Palo Alto (17 mi)

+121 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Amgen

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?This trial is testing two doses of sotorasib combined with panitumumab in patients with a specific type of colorectal cancer that has not responded to other treatments. Sotorasib targets a genetic mutation in the cancer cells, while panitumumab helps the immune system attack the cancer. The goal is to see if this combination can help patients live longer without their cancer getting worse.

Eligibility Criteria

Adults over 18 with metastatic colorectal cancer that has a specific mutation (KRAS p.G12C) can join this trial. They must have tried at least one other treatment and their cancer should be measurable by certain medical criteria. Good organ function and performance status are required, but those with severe skin, breast, or prostate conditions without current disease, brain metastases treated over 4 weeks ago without progression, or other cancers cured more than 3 years ago may also qualify.

Inclusion Criteria

- International normalized ratio (INR) and activated partial thromboplastin time (or partial thromboplastin time) ≤1.5 x ULN. Prothrombin time (PT) ≤1.5 x ULN may be used instead of INR for sites whose labs do not report INR.

- Fridericia's Correction Formula (QTcF) ≤470 msec.

My cancer can be measured by scans and has grown after any radiation treatments.

+15 more

Exclusion Criteria

My bladder cancer has been treated and is not invasive.

I had skin cancer (not melanoma) treated and currently show no signs of it.

My cancer was treated over 3 years ago, with no current signs of it and considered low risk for coming back.

+11 more

Participant Groups

The study is testing the effectiveness of Sotorasib combined with Panitumumab against either Trifluridine/Tipiracil or Regorafenib in patients whose colorectal cancer has progressed after previous treatments. The main goal is to see which combination helps slow down the cancer's growth better.

3Treatment groups

Experimental Treatment

Active Control

Group I: Arm B: Sotorasib 240 mg QD + panitumumabExperimental Treatment2 Interventions

Group II: Arm A: Sotorasib 960 mg QD + panitumumabExperimental Treatment2 Interventions

Group III: Arm C : Investigator's choiceActive Control2 Interventions

Participants will be administered trifluridine and tipiracil, or regorafenib

Panitumumab is already approved in European Union, United States for the following indications:

🇪🇺 Approved in European Union as Vectibix for: