Randomized PhIII Study of XL092 + Atezolizumab vs Regorafenib in Subjects with Meta Colorectal Ca

Official Title

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

Details

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 after or are intolerant to standard-of-care (SOC) therapy.

You can join if...

Inclusion Criteria:

1. You must have histologically or cytologically confirmed adenocarcinoma of the colon or rectum.
2. You must have received standard-of-care (SOC) anticancer therapies as prior therapy for metastatic CRC and has radiographically progressed, is refractory or intolerant to these therapies.
3. You must have radiographic progression during treatment with or within 3 months following the last dose of the most recent approved SOC chemotherapy regimen.
4. Age 18 years or older on the day of consent.
5. You must have adequate organ and marrow function.

Exclusion Criteria:

1. You must have not received prior treatment with XL092, regorafenib, trifluridine/tipiracil, or PD-L1/PD-1 targeting immune checkpoint inhibitors (ICIs).
2. You must have not received receipt of a small molecule kinase inhibitor (including investigational agents) within 2 weeks before randomization.
3. You must not have 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.
4. You must not have any concomitant anticoagulation with oral anticoagulants and platelet inhibitors.
5. You must not be pregnant or lactating.
6. You must not have administration of a live, attenuated vaccine within 30 days before randomization.