XTX202 in Patients With Advanced Solid Tumors

NCT ID: NCT05052268

Last Updated: 2025-05-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 95 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-18
• Study Completion Date: 2025-03-25

Brief Summary

A First-in-Human, Multicenter, Phase 1/2, Open-Label Study of XTX202 in Patients with Advanced Solid Tumors

Detailed Description

This is a first-in-human, Phase 1/2, multicenter, open-label study designed to evaluate the safety, tolerability, and efficacy of XTX202, an engineered IL-2 prodrug with its activity masked, as monotherapy in patients with advanced solid tumors.

Phase 1 Part 1a will examine XTX202 monotherapy in an accelerated and standard 3+3 dose-escalation design. Based on the results of Part 1a, Part 1b will be initiated to further examine XTX202 in patients with select advanced solid tumors and to further characterize XTX202.

Based on results of Phase 1 patients with select advanced solid tumors will be enrolled in Phase 2.

Conditions

Advanced Solid Tumor

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Phase 1 XTX202 Dose Escalation and Pharmacodynamics Expansion

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

Group Type: EXPERIMENTAL

XTX202

Intervention Type: DRUG

XTX202 Monotherapy

Phase 2 XTX202 Dose Expansion

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 Type: EXPERIMENTAL

XTX202

Intervention Type: DRUG

XTX202 Monotherapy

Interventions

XTX202

XTX202 Monotherapy

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Disease Criteria

• Phase 1, Part 1a: Any histologically or cytologically confirmed solid tumor malignancy that is locally advanced or metastatic and has failed standard therapy, or standard therapy is not curative or available
• Phase 1, Part 1b: Histologically or cytologically confirmed solid tumor malignancy with one of the following tumor histologies: RCC of clear cell histology only, melanoma, squamous cell skin carcinoma, ovarian cancer, non-small cell lung cancer. Those patients who previously received immunotherapy must have derived benefit from this treatment. Additionally, patients with any of the above histologies in an advanced setting who plan to undergo debulking surgery or oligometastasectomy may be eligible to receive 2 cycles of XTX202 treatment in a "window of opportunity" subcohort".
• Phase 2, Part 2a: Patients with metastatic RCC who have previously been treated with an anti-PD-1 and a TKI, per local and institutional SOC. Patients must have progressed on treatment with an anti-PD-1 mAb administered either as monotherapy or in combination with other therapies
• Phase 2, Part 2b: Patients with unresectable or metastatic melanoma who have previously been treated with at least 1 prior line of therapy in the recurrent or metastatic setting. Prior therapy must have included an anti-PD-1 alone or in combination per local and institutional standard of care, and patient must have progressed on checkpoint inhibitor therapy. Patients with BRAF V600-activating mutation must have previously received targeted therapy per local and institutional standard of care.

2. ECOG performance status of 0 or 1

3. Adequate organ function

4. Part 1b only patients must be willing to provide fresh tumor biopsies before and after initiation of study treatment.

Exclusion Criteria

1. Received prior treatment with IL-2 therapy

2. History of clinically significant pulmonary disease

3. History of clinically significant cardiovascular disease

4. Has a diagnosis of immunodeficiency

5. Has an active autoimmune disease that has required systemic treatment in past 2 years, including the use of disease modifying agents, corticosteroids or immunosuppressive drugs

6. Has an active infection requiring systemic therapy within 4 weeks prior to study treatment

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xilio Development, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

UC San Diego Moores Cancer Center

La Jolla, California, United States

Norris Comprehensive Cancer Center

Los Angeles, California, United States

University of California Los Angeles

Los Angeles, California, United States

Hoag Memorial Hospital Presbyterian- Newport Beach

Newport Beach, California, United States

Georgetown University Medical Center

Washington D.C., District of Columbia, United States

Moffitt Cancer Center

Tampa, Florida, United States

University of Iowa Hospitals and Clinics

Iowa City, Iowa, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

HealthPartners Cancer Center at Regions Hospital

Saint Paul, Minnesota, United States

Atlantic Health System/Morristown Medical Center

Morristown, New Jersey, United States

Rutgers Cancer Institute of NJ

New Brunswick, New Jersey, United States

Carolina BioOncology Institute

Huntersville, North Carolina, United States

The Ohio State University Wexner Medical Center James Cancer Hospital and Solove Research Institute

Columbus, Ohio, United States

UPMC Hillman Cancer Center Pavilion

Pittsburgh, Pennsylvania, United States

Sarah Cannon Research Institute

Nashville, Tennessee, United States

Countries

United States

Other Identifiers

XTX202-01/02-001

Identifier Type: -

Identifier Source: org_study_id