RECRUITING

XTX301 in Patients with Advanced Solid Tumors

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This is a first-in-human, multicenter, Phase 1/2, open-label study designed to evaluate the safety and tolerability of XTX301 as monotherapy in patients with advanced solid tumors.

Official Title

A First-in-Human, Multicenter, Phase 1/2, Open-Label Study of XTX301 in Patients with Advanced Solid Tumors

Quick Facts

Study Start:2023-05-11

Study Completion:2027-02

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05684965

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* ECOG performance status of 0-2 * Adequate organ function * Tumor tissue samples: Part 1B: patients must have lesions amenable to biopsy and be willing and able to provide fresh tumor biopsies before and after initiation of treatment * Patients with recent major surgery must have adequately recovered with no ongoing complications from the surgery before receiving study drug	* Prior treatment with IL-12 therapy (any form, e.g. recombinant human, prodrug, intratumoral, etc.) * Known liver metastasis based on imaging * Possible area of ongoing necrosis (non-disease-related), such as active ulcer, nonhealing wound, or intercurrent bone fracture * Active primary central nervous system (CNS) malignancy, CNS metastases, and/or carcinomatous meningitis * Active autoimmune disease * History of Grade ≥ 3 immune-related adverse events associated with prior immunotherapy unless these were adequately resolved with therapy within 14 days * A diagnosis of immunodeficiency; receiving chronic systemic therapy exceeding prednisone 10 mg daily or equivalent or any other form of immunosuppressive therapy within 7 days before the first dose of study drug * Active hepatitis B or active hepatitis C infection * Prior treatment with gene therapy, organ transplant, or hematopoietic stem-cell transplant

Inclusion Criteria

Exclusion Criteria

* ECOG performance status of 0-2
* Adequate organ function
* Tumor tissue samples: Part 1B: patients must have lesions amenable to biopsy and be willing and able to provide fresh tumor biopsies before and after initiation of treatment
* Patients with recent major surgery must have adequately recovered with no ongoing complications from the surgery before receiving study drug

* Prior treatment with IL-12 therapy (any form, e.g. recombinant human, prodrug, intratumoral, etc.)
* Known liver metastasis based on imaging
* Possible area of ongoing necrosis (non-disease-related), such as active ulcer, nonhealing wound, or intercurrent bone fracture
* Active primary central nervous system (CNS) malignancy, CNS metastases, and/or carcinomatous meningitis
* Active autoimmune disease
* History of Grade ≥ 3 immune-related adverse events associated with prior immunotherapy unless these were adequately resolved with therapy within 14 days
* A diagnosis of immunodeficiency; receiving chronic systemic therapy exceeding prednisone 10 mg daily or equivalent or any other form of immunosuppressive therapy within 7 days before the first dose of study drug
* Active hepatitis B or active hepatitis C infection
* Prior treatment with gene therapy, organ transplant, or hematopoietic stem-cell transplant

Contacts and Locations

Study Contact

Xilio Medical Affairs

CONTACT

(857) 524-2466

medicalaffairs@xiliotx.com

Study Locations (Sites)

University of California, Davis Comprehensive Cancer Center

Sacramento, California, 95817

United States

Yale Cancer Center

New Haven, Connecticut, 06510

United States

HealthPartners Frauenshuh Cancer center

St. Louis Park, Minnesota, 55426

United States

Washington University School of Medicine

Saint Louis, Missouri, 63110

United States

Hackensack University Medical Center

Hackensack, New Jersey, 07601

United States

The Gabrail Pharmacology Phase 1 Research Center

Canton, Ohio, 44718

United States

University Hospital Cleveland Medical Center

Cleveland, Ohio, 44106

United States

The Ohio State University Wexner Medical Center

Columbus, Ohio, 43221

United States

University of Pittsburgh Medical Center-Hillman Cancer Center

Pittsburgh, Pennsylvania, 15232

United States

Tranquil Clinical Research

Webster, Texas, 77598

United States

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226

United States

Collaborators and Investigators

Sponsor: Xilio Development, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-05-11

Study Completion Date2027-02

Study Record Updates

Study Start Date2023-05-11

Study Completion Date2027-02

Terms related to this study

Additional Relevant MeSH Terms

Advanced Solid Tumor