XTX202 in Patients With Advanced Solid Tumors

  • STATUS
    Recruiting
  • End date
    Apr 30, 2024
  • participants needed
    120
  • sponsor
    Xilio Development, Inc.
Updated on 7 October 2022
Investigator
Lisaq Wahowske, RN
Primary Contact
HealthPartners Cancer Center at Regions Hospital (8.9 mi away) Contact
+6 other location

Summary

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

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 will examine XTX202 monotherapy in an accelerated and standard 3+3 dose-escalation design. Based on the results of Phase 1, patients with select advanced solid tumors will be enrolled in Phase 2.

Details
Condition Advanced Solid Tumor
Treatment XTX202
Clinical Study IdentifierNCT05052268
SponsorXilio Development, Inc.
Last Modified on7 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Disease Criteria - Phase 1: 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 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

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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