Melanoma Clinical Trial

XTX202 in Patients With Advanced Solid Tumors

Summary

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

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Full 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.

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Eligibility Criteria

Inclusion Criteria:

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. Patients must have been treated with available standard therapy. 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 approved anti-PD-1 and a TKI. 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 an approved anti-PD-1 and an anti-CTLA4 checkpoint inhibitor
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.

Exclusion Criteria:

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

Study is for people with:

Melanoma

Phase:

Phase 1

Estimated Enrollment:

189

Study ID:

NCT05052268

Recruitment Status:

Recruiting

Sponsor:

Xilio Development, Inc.

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There are 8 Locations for this study

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Norris Comprehensive Cancer Center
Los Angeles California, 90033, United States More Info
Diana Hanna, MD
Contact
949-764-6755
[email protected]
Diana Hanna, MD
Principal Investigator
Hoag Memorial Hospital Presbyterian- Newport Beach
Newport Beach California, 92663, United States More Info
Xiomara Menendez, RN
Contact
323-409-4368
[email protected]
Diana Hanna, MD
Principal Investigator
University of Iowa Hospitals and Clinics
Iowa City Iowa, 52242, United States More Info
Yousef Zakharia, MD
Contact
319-467-0697
[email protected]
Yousef Zakharia, MD
Principal Investigator
Massachusetts General Hospital
Boston Massachusetts, 02114, United States More Info
Andrea Ozuna
Contact
617-726-2667
[email protected]
David Miller, MD
Principal Investigator
HealthPartners Cancer Center at Regions Hospital
Saint Paul Minnesota, 55101, United States More Info
Lisa Wahowske, RN
Contact
651-254-1517
[email protected]
Arkadiusz Dudek, MD
Principal Investigator
Carolina BioOncology Institute
Huntersville North Carolina, 28078, United States More Info
Ashley McClain Wallace
Contact
980-441-1021
[email protected]
John Powderly, MD
Principal Investigator
The Ohio State University Wexner Medical Center James Cancer Hospital and Solove Research Institute
Columbus Ohio, 43210, United States More Info
Lisa Brenner
Contact
614-293-7843
[email protected]
Richard Wu, MD
Principal Investigator
Sarah Cannon Research Institute
Nashville Tennessee, 37203, United States More Info
Meredith McKean, MD
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Melanoma

Phase:

Phase 1

Estimated Enrollment:

189

Study ID:

NCT05052268

Recruitment Status:

Recruiting

Sponsor:


Xilio Development, Inc.

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