XTX202 in Patients With Advanced Solid Tumors

NCT05052268 | Completed Phase 1 FDA Drug

• 1 other identifier: XTX202-01/02-001
• Study Type: interventional
• Target: 95
• Locations: 1 country
• Sites: 15

Brief Summary

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

Conditions

Advanced Solid Tumor

Outcome Measures

Primary Outcomes (4)

• Incidence of Dose Limiting Toxicities (DLTs) (Phase 1 Part 1A only)

  Cycle 1 day 1 up to just prior to the second dose of study drug at Cycle 2 day 1 (each cycle is 21 days)

• Incidence of treatment-emergent adverse events (Phase 1 only)

  Up to 24 months

• Incidence of changes in clinical laboratory values (Phase 1 only)

  Up to 24 months

• Investigator-assessed objective response rate (ORR) per RECIST 1.1 (Phase 2 only)

  Up to 24 months

Secondary Outcomes (16)

• Plasma concentrations of XTX202 (total and intact)

  Up to Cycle 7 (21 days per cycle)

• Maximum observed plasma concentration (Cmax)

  Up to Cycle 7 (21 days per cycle)

• Time of maximum observed concentration (Tmax)

  Up to Cycle 7 (21 days per cycle)

• Trough concentrations (Ctrough)

  Up to Cycle 7 (21 days per cycle)

• Area under the curve (AUC)

  Up to Cycle 7 (21 days per cycle)

Study Arms (2)

Phase 1 XTX202 Dose Escalation and Pharmacodynamics Expansion

EXPERIMENTAL

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

Drug: XTX202

Phase 2 XTX202 Dose Expansion

EXPERIMENTAL

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.

Drug: XTX202

Interventions

XTX202 DRUG

XTX202 Monotherapy

Phase 1 XTX202 Dose Escalation and Pharmacodynamics Expansion; Phase 2 XTX202 Dose Expansion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• ECOG performance status of 0 or 1
• Adequate organ function
• Part 1b only patients must be willing to provide fresh tumor biopsies before and after initiation of study treatment.

You may not qualify if:

• Received prior treatment with IL-2 therapy
• History of clinically significant pulmonary disease
• History of clinically significant cardiovascular disease
• Has a diagnosis of immunodeficiency
• 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
• Has an active infection requiring systemic therapy within 4 weeks prior to study treatment

Sponsors & Collaborators

• Xilio Development, Inc.: lead

Study Sites (15)

UC San Diego Moores Cancer Center

La Jolla, California, 92093, United States

Location

Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

Location

University of California Los Angeles

Los Angeles, California, 90095, United States

Location

Hoag Memorial Hospital Presbyterian- Newport Beach

Newport Beach, California, 92663, United States

Location

Georgetown University Medical Center

Washington D.C., District of Columbia, 20007, United States

Location

Moffitt Cancer Center

Tampa, Florida, 33612, United States

Location

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

HealthPartners Cancer Center at Regions Hospital

Saint Paul, Minnesota, 55101, United States

Location

Atlantic Health System/Morristown Medical Center

Morristown, New Jersey, 07960, United States

Location

Rutgers Cancer Institute of NJ

New Brunswick, New Jersey, 08903, United States

Location

Carolina BioOncology Institute

Huntersville, North Carolina, 28078, United States

Location

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

Columbus, Ohio, 43210, United States

Location

UPMC Hillman Cancer Center Pavilion

Pittsburgh, Pennsylvania, 15213, United States

Location

Sarah Cannon Research Institute

Nashville, Tennessee, 37203, United States

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2021
• First Posted: September 22, 2021
• Study Start: January 18, 2022
• Primary Completion: March 22, 2025
• Study Completion: March 25, 2025
• Last Updated: May 7, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (15)