XTX202 for Solid Tumors

Recruiting in Palo Alto (17 mi)

+14 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: Xilio Development, Inc.

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial is testing XTX202, a new drug designed to treat advanced cancers. It targets patients with late-stage solid tumors that may not respond to other treatments. The drug remains inactive until it reaches the tumor, where it then activates to help the immune system fight the cancer.

Eligibility Criteria

This trial is for adults with advanced solid tumors that have failed standard treatments or where no curative treatment exists. It's open to those in good physical condition (ECOG 0-1) and includes specific cancer types like RCC, melanoma, and lung cancer if they've benefited from immunotherapy before. Patients must not have significant heart disease, immune deficiencies, active infections needing systemic therapy recently, autoimmune diseases treated within the last two years, prior IL-2 therapy or serious lung disease.

Inclusion Criteria

I have a specific type of cancer and benefited from previous immunotherapy.

My cancer is advanced or has spread, and standard treatments have failed or aren't suitable.

I have melanoma that can't be removed by surgery and it got worse after treatment including an anti-PD-1.

See 5 more

Exclusion Criteria

I have not had an infection needing treatment in the last 4 weeks.

I have a serious lung condition.

I have an autoimmune disease treated with strong medication in the last 2 years.

See 3 more

Treatment Details

Interventions

XTX202 (Unknown)

Trial OverviewXTX202 is being tested as a new potential treatment for various advanced solid tumors. The study has multiple phases: early ones assess safety and dosage in different cancers; later phases focus on effectiveness in kidney cancer (RCC) after anti-PD-1/TKI therapies and melanoma post checkpoint inhibitor therapy. Some patients may receive XTX202 before surgery to reduce tumor size.

Participant Groups

2Treatment groups

Experimental Treatment

Group I: Phase 2 XTX202 Dose ExpansionExperimental Treatment1 Intervention

Part 2A will enroll patients with metastatic renal cell carcinoma who have progressed following standard-of-care treatment. Part 2B will enroll patients with melanoma who have progressed following standard-of-care treatment.

Group II: Phase 1 XTX202 Dose Escalation and Pharmacodynamics ExpansionExperimental Treatment1 Intervention

Part 1A Dose Escalation of XTX202 administered in ascending doses to patients with advanced or metastatic solid tumors to find the recommended phase 2 doses (RP2Ds). Part 1B Evaluation of XTX202 in patients with selected advanced solid tumors to further characterize the pharmacodynamic profile of XTX202