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NCT Number: NCT05425940

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Exelixis Clinical Site #83, Albury, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

XL092

Drug

Supplied as tablets; administered orally daily.

Atezolizumab

Drug

Supplied as 1200 milligrams (mg)/20 milliliter (mL) vials; administered as a 1200 mg intravenous (IV) infusion once in a 3-week cycle (q3w).

Other names: Tecentriq®

regorafenib

Drug

Supplied as 40 mg tablets; administered orally daily at 160 mg for the first 21 days of each 28-day cycle.

Other names: Stivarga®

Primary outcomes

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

    Time frame: Up to 32 months

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

    Time frame: Up to 32 months

Secondary outcomes

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

    Time frame: Up to 26 months

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

    Time frame: Up to 36 months

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

    Time frame: Up to 36 months

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

    Time frame: Up to 36 months

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

    Time frame: Predose up to 72 hours postdose

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

    Time frame: Predose up to 72 hours postdose

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

    Time frame: Up to 36 months

Sponsors and collaborators

Lead sponsor

Exelixis

Industry

Registry information

Official study title

A Randomized Open-Label Phase 3 Study of XL092 + Atezolizumab vs Regorafenib in Subjects With Metastatic Colorectal Cancer

Acronym: STELLAR-303

Important dates

Study start
2022
Primary completion
2026
Study completion
2027
First posted
Jun 21, 2022
Registry last updated
Jul 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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