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

Phase
Recruitment status
Active, not recruiting
Participants
Lead sponsor
Start date
Number of sites

Summary
The primary purpose of this study is to evaluate XL092 + atezolizumab versus regorafenib in participants 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.
Acronym
Short title
Study of XL092 + Atezolizumab vs Regorafenib in Participants With Metastatic Colorectal Cancer
Official title
A Randomized Open-Label Phase 3 Study of XL092 + Atezolizumab vs Regorafenib in Subjects With Metastatic Colorectal Cancer

Control arm
Active comparator
Registry reports results
Listing at source
Recruitment status
Active, not recruiting
Phase
Study type
Interventional

Completion date
First posted
Registry last updated
Primary completion date
Start date

Actual participants
Participants
Participant count basis
Protocol amendments
Number of sites

Data monitoring committee
Registry sponsor category
Lead sponsor
Source registry
ClinicalTrials.gov

Registry ID
ClinicalTrials.gov ID
Registry record
Open registry record

Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
No masking
Sources for study design

  1. Overall Survival (OS) of XL092 + Atezolizumab Versus Regorafenib in All Randomized Participants

    Timeframe: Up to 32 months

  2. Overall Survival (OS) of XL092 + Atezolizumab Versus Regorafenib in Randomized Non-Liver Metastases (NLM) Participants

    Timeframe: Up to 32 months

  1. Progression-Free Survival (PFS) as Assessed by the Investigator

    Timeframe: Up to 26 months

  2. Duration of Response (DOR) as Assessed by the Investigator

    Timeframe: Up to 36 months

  3. Objective Response Rate (ORR) as Assessed by the Investigator

    Timeframe: Up to 36 months

  4. Number of Participants with Treatment Emergent Adverse Events (TEAEs)

    Timeframe: Up to 36 months

  5. Maximum Observed Plasma Drug Concentration (Cmax) of XL092

    Timeframe: Predose up to 72 hours postdose

  6. Time to Maximum Observed Plasma Drug Concentration (Tmax) of XL092

    Timeframe: Predose up to 72 hours postdose

  7. Number of Participants who Develop Antidrug Antibodies (ADA) Against Atezolizumab

    Timeframe: Up to 36 months

Sources for outcomes

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

Key Inclusion Criteria:

  • Participants with histologically or cytologically confirmed adenocarcinoma of the colon or rectum.

    • Documented rat sarcoma (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 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 participant 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 Response Evaluation Criteria in Solid Tumors (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 (common terminology criteria for adverse events [CTCAE] version 5) from adverse events (AEs) related to any prior treatments, unless AE(s) are clinically nonsignificant and/or stable on supportive therapy.

  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.

  • Adequate organ and marrow function.

  • Fertile participants 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.

  • Females of childbearing potential must not be pregnant at screening.

Key Exclusion Criteria:

  • Prior treatment with XL092, regorafenib, trifluridine/tipiracil, or programmed cell death protein-1/and its ligand (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.
  • Has uncontrolled, significant intercurrent or recent illness.
  • Major surgery (example, gastrointestinal (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 milliseconds (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.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Sources for eligibility

  • Exelixis Clinical Site #65Jonesboro, United States
  • Exelixis Clinical Site #30Phoenix, United States
  • Exelixis Clinical Site #70Tucson, United States
  • Exelixis Clinical Site #9Duarte, United States
  • Exelixis Clinical Site #55La Jolla, United States
  • Exelixis Clinical Site #77Los Angeles, United States
  • Exelixis Clinical Site #105Orange, United States
  • Exelixis Clinical Site #80Santa Monica, United States
  • Exelixis Clinical Site #5Santa Rosa, United States
  • Exelixis Clinical Site #82Sylmar, United States
  • Exelixis Clinical Site #58Torrance, United States
  • Exelixis Clinical Site #81Whittier, United States
  • Exelixis Clinical Site #125New Haven, United States
  • Exelixis Clinical Site #16Miami Beach, United States
  • Exelixis Clinical Site #60Orlando, United States
  • Exelixis Clinical Site #4Marietta, United States
  • Exelixis Clinical Site #3Joliet, United States
  • Exelixis Clinical Site #102Indianapolis, United States
  • Exelixis Clinical Site #10Westwood, United States
  • Exelixis Clinical Site #47Lexington, United States
  • Exelixis Clinical Site #7New Orleans, United States
  • Exelixis Clinical Site #22St Louis, United States
  • Exelixis Clinical Site #8Billings, United States
  • Exelixis Clinical Site #1Omaha, United States
  • Exelixis Clinical Site #15Albuquerque, United States

And 108 more, listed on the interactive page.

Sources for sites

Other registry identifiers

  • 2021-003243-21
Sources for references

Related records

Drugs (3)

Lead sponsors (1)

Conditions (2)

Targets (23)