XTX202 for Solid Tumors

Recruiting at 14 trial locations

Overseen By Katarina Luptakova, MD

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Xilio Development, Inc.

Must not be taking: Il-2 therapy, Corticosteroids

Disqualifiers: Pulmonary, Cardiovascular, Immunodeficiency, Autoimmune, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

95 Participants Needed

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.

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase 1 Treatment

Phase 1 Part 1a involves dose escalation of XTX202 to determine the recommended phase 2 doses, followed by Part 1b to further characterize XTX202 in select tumors

12-16 weeks

Phase 2 Treatment

Phase 2 involves dose expansion of XTX202 in patients with metastatic renal cell carcinoma and melanoma

16-24 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-8 weeks

Treatment Details

Interventions

• XTX202

Trial Overview XTX202 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

Group I: Phase 2 XTX202 Dose Expansion Experimental Treatment 1 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 Expansion Experimental Treatment 1 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

Who Is Running the Clinical Trial?

Xilio Development, Inc.

Lead Sponsor

Trials

3

Recruited

680+