XL092 + Immunotherapy for Cancer
(STELLAR-001 Trial)

Recruiting in Palo Alto (17 mi)

+91 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Exelixis

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?This trial is testing a new drug called XL092 by itself and with two other drugs, atezolizumab and avelumab. It targets patients with advanced solid tumors who may not respond to current treatments. XL092 aims to stop cancer cells from growing, while atezolizumab and avelumab help the immune system fight the cancer. Atezolizumab is approved for various cancers, including breast and urothelial carcinoma, and has shown efficacy in combination with chemotherapy.

Eligibility Criteria

This trial is for adults with advanced solid tumors that are inoperable or metastatic, and who have tried other treatments without success. They must be mostly recovered from previous treatment side effects, not pregnant, able to use contraception, and have good organ function. People with certain cancers like colorectal cancer must meet specific genetic criteria.

Inclusion Criteria

I have recovered from previous treatment side effects, or they are mild and stable.

I am not pregnant and can become pregnant.

My colon or rectum cancer is advanced, cannot be surgically removed, and lacks certain genetic mutations.

+11 more

Exclusion Criteria

I have not received a live vaccine within the last 30 days.

I have previously been treated with XL092, PD-L1/PD-1 inhibitors, regorafenib, or TAS-102 depending on my trial cohort.

I haven't had radiation for bone metastasis in the last 2 weeks or any other radiation in the last 4 weeks.

+11 more

Participant Groups

The study tests XL092 alone or combined with Atezolizumab or Avelumab in patients with various solid tumors. It's an early-phase trial to check safety, how the body processes the drugs (pharmacokinetics), their effect on tumor markers, and initial effectiveness against the cancer.

5Treatment groups

Experimental Treatment

Group I: XL092 Single-Agent Expansion CohortsExperimental Treatment1 Intervention

The MTD or recommended dose from the dose-escalation stage may be further explored in clear cell renal cell carcinoma (ccRCC), non-clear cell renal cell carcinoma (nccRCC), hormone receptor-positive breast cancer (HR+ BC), and metastatic castration-resistant prostate cancer (mCRPC).

Group II: XL092 Single-Agent Dose-Escalation CohortsExperimental Treatment1 Intervention

Subjects will accrue in cohorts of 3-6 subjects in a standard "3 plus 3" design.

Group III: XL092 + Avelumab Dose-Escalation CohortsExperimental Treatment2 Interventions

Subjects will accrue in cohorts of 2-6 subjects in a "rolling 6" design.

Group IV: XL092 + Atezolizumab Expansion CohortsExperimental Treatment2 Interventions

The MTD or recommended dose from the dose-escalation stage may be further explored in non-clear cell renal cell carcinoma (nccRCC), hormone receptor-positive breast cancer (HR+ BC), metastatic castration-resistant prostate cancer (mCRPC), and colorectal cancer (CRC).

Group V: XL092 + Atezolizumab Dose-Escalation CohortsExperimental Treatment2 Interventions

Subjects will accrue in cohorts of 2-6 subjects in a "rolling 6" design.