Study Comparing XL092 and Atezolizumab with Regorafenib for Metastatic Colorectal Cancer

Sponsor: Exelixis

Sponsor score: 40

ClinicalTrials ID:NCT05425940

This clinical trial is testing a new combination of drugs, XL092 and atezolizumab, against regorafenib in patients with metastatic colorectal cancer that has not responded to standard treatments.

Patient Parameters

Program Overview

The main goal of this study is to compare the effectiveness of a new drug combination, XL092 and atezolizumab, with an existing drug, regorafenib, in treating patients with metastatic colorectal cancer that is stable or has low instability in its genetic makeup (MSS/MSI-low). These patients have either not responded to, stopped responding to, or cannot tolerate standard cancer treatments.

Eligibility Criteria

Inclusion Criteria

  • Have a confirmed diagnosis of colon or rectal cancer.
  • Have documented RAS gene status (either mutated or normal).
  • Do not have high microsatellite instability or mismatch repair deficiency in the cancer.
  • Have received standard cancer treatments for metastatic colorectal cancer but the cancer has progressed or the patient cannot tolerate these treatments.
  • Have measurable cancer according to specific medical criteria.
  • Can provide a previous or new tumor sample for analysis.
  • Have recovered from any side effects of previous treatments to a mild level or better.
  • Have a performance status score of 0 or 1, indicating full activity or some restriction in strenuous activities.
  • Have adequate organ and bone marrow function.
  • Agree to use effective contraception during and after the study if fertile.
  • Women must not be pregnant at the start of the study.

Exclusion Criteria

  • Have previously been treated with XL092, regorafenib, or certain other cancer drugs.
  • Have taken a small molecule kinase inhibitor within 2 weeks before starting the study.
  • Have received any type of cancer antibody therapy, chemotherapy, or hormonal therapy within 3 weeks (or bevacizumab within 4 weeks) before starting the study.
  • Have had radiation therapy for bone metastasis within 2 weeks, or any other radiation therapy within 4 weeks before starting the study.
  • Have untreated or unstable brain metastases.
  • Have uncontrolled or significant recent illness.
  • Have had major surgery within 4 weeks before starting the study.
  • Are taking corticosteroids or other immunosuppressive medications within 14 days before starting the study.
  • Have a heart condition affecting the QT interval on an ECG.
  • Have a psychiatric illness that may interfere with the study.
  • Are pregnant or breastfeeding.
  • Cannot swallow pills or have a condition affecting drug absorption.
  • Have allergies to the study drugs.
  • Have another active cancer or had another cancer diagnosis within 2 years before starting the study.
  • Have received a live vaccine within 30 days before starting the study.

Locations

FACILITYZIPCITYSTATE
Exelixis Clinical Site #6572401JonesboroAlabama
Exelixis Clinical Site #3085004PhoenixArizona
Exelixis Clinical Site #7085719TucsonArizona
Exelixis Clinical Site #991010DuarteCalifornia
Exelixis Clinical Site #5592037La JollaCalifornia
Exelixis Clinical Site #7790095Los AngelesCalifornia
Exelixis Clinical Site #10592868OrangeCalifornia
Exelixis Clinical Site #8090404Santa MonicaCalifornia
Exelixis Clinical Site #595403Santa RosaCalifornia
Exelixis Clinical Site #8291342SylmarCalifornia

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