Open Actively Recruiting

Study of XL092 + Atezolizumab vs Regorafenib in Subjects With Metastatic Colorectal Cancer

About

Brief Summary

This is a multicenter, randomized, open-label, controlled Phase 3 trial of XL092 + atezolizumab vs regorafenib in subjects with microsatellite stable/microsatellite instability low (MSS/MSI-low) metastatic colorectal cancer (mCRC) who have progressed during, after or are intolerant to standard-of-care (SOC) therapy.

Primary Purpose
Treatment
Study Type
Interventional
Phase
Phase 3

Eligibility

Gender
All
Healthy Volunteers
No
Minimum Age
18 Years
Maximum Age
N/A

Inclusion Criteria:

  • Subjects with histologically or cytologically confirmed adenocarcinoma of the colon or rectum.
    • Documented RAS status (mutant or wild-type [WT]), by tissue-based analysis.
    • Documented NOT to have microsatellite instability-high (MSI-high) or mismatch repair deficient (dMMR) CRC by tissue-based analysis.
  • Has received standard-of-care (SOC) anticancer therapies as prior therapy for metastatic CRC and has radiographically progressed, is refractory or intolerant to these therapies.
    • Systemic SOC anticancer therapy if approved and available in the country where the subject is randomized.
    • Radiographic progression during treatment with or within 4 months following the last dose of the most recent approved SOC chemotherapy regimen.
  • Measurable disease according to RECIST v1.1 as determined by the Investigator.
  • Available archival tumor biopsy material. If archival tissue is unavailable, must provide fresh tumor tissue biopsy prior to randomization.
  • Recovery to baseline or ≤ Grade 1 severity (CTCAE v5) from adverse events (AEs) related to any prior treatments, unless AE(s) are clinically nonsignificant and/or stable on supportive therapy.
  • Age 18 years or older on the day of consent.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
  • Adequate organ and marrow function.
  • Fertile subjects and their partners must agree to use highly effective methods of contraception during the course of the study and after the last dose of treatment.
  • Female subjects of childbearing potential must not be pregnant at screening.

Exclusion Criteria:

  • Prior treatment with XL092, regorafenib, trifluridine/tipiracil, or PD-L1/PD-1 targeting immune checkpoint inhibitors (ICIs).
  • Receipt of a small molecule kinase inhibitor (including investigational agents) within 2 weeks before randomization.
  • Receipt of any type of anticancer antibody therapy, systemic chemotherapy, or hormonal anti-cancer therapy within 3 weeks (or bevacizumab within 4 weeks) before randomization.
  • Radiation therapy for bone metastasis within 2 weeks, any other radiation therapy within 4 weeks before randomization.
  • Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and/or surgery (including radiosurgery) and stable for at least 4 weeks before randomization.
  • Subject has uncontrolled, significant intercurrent or recent illness.
  • Major surgery (e.g., GI surgery, removal or biopsy of brain metastasis) within 4 weeks prior to randomization.
  • Systemic treatment with, or any condition requiring, either corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days prior to randomization.
  • Corrected QT interval calculated by the Fridericia formula (QTcF) > 460 ms within 10 days before randomization.
  • History of psychiatric illness likely to interfere with ability to comply with protocol requirements or give informed consent.
  • Pregnant or lactating females.
  • Inability to swallow study treatment formulation, inability to receive IV administration, or presence of GI condition that might affect the absorption of study drug.
  • Previously identified allergy or hypersensitivity to components of the study treatment formulations.
  • Any other active malignancy or diagnosis of another malignancy within 2 years before randomization. Exceptions are noted in the protocol.
  • Administration of a live, attenuated vaccine within 30 days before randomization.

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Study Stats
Protocol No.
23-000253
Category
Colorectal Cancer
Contact
Rachel Andes
Location
  • TRIO-US - Jonesboro AR
  • TRIO-US - Orlando FL
  • TRIO-US - Redondo Beach
  • TRIO-US - Sylmar
  • TRIO-US - Whittier
  • UCLA Alhambra
  • UCLA Beverly Hills
  • UCLA Burbank
  • UCLA Irvine
  • UCLA Laguna Hills
  • UCLA Pasadena
  • UCLA Porter Ranch
  • UCLA San Luis Obispo
  • UCLA Santa Barbara
  • UCLA Santa Monica
  • UCLA Valencia
  • UCLA Ventura
  • UCLA Westlake Village
For Providers
NCT No.
NCT05425940
For detailed technical eligibility, visit ClinicalTrials.gov.