XTX301 in Patients with Advanced Solid Tumors

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.

Conditions

Advanced Solid Tumor

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Study Overview

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Study Details

Study overview

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.

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

XTX301 in Patients with Advanced Solid Tumors

Condition
Advanced Solid Tumor
Intervention / Treatment

-

Contacts and Locations

Sacramento

University of California, Davis Comprehensive Cancer Center, Sacramento, California, United States, 95817

New Haven

Yale Cancer Center, New Haven, Connecticut, United States, 06510

St. Louis Park

HealthPartners Frauenshuh Cancer center, St. Louis Park, Minnesota, United States, 55426

Saint Louis

Washington University School of Medicine, Saint Louis, Missouri, United States, 63110

Hackensack

Hackensack University Medical Center, Hackensack, New Jersey, United States, 07601

Canton

The Gabrail Pharmacology Phase 1 Research Center, Canton, Ohio, United States, 44718

Cleveland

University Hospital Cleveland Medical Center, Cleveland, Ohio, United States, 44106

Columbus

The Ohio State University Wexner Medical Center, Columbus, Ohio, United States, 43221

Pittsburgh

University of Pittsburgh Medical Center-Hillman Cancer Center, Pittsburgh, Pennsylvania, United States, 15232

Webster

Tranquil Clinical Research, Webster, Texas, United States, 77598

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Xilio Development, Inc.,

Study Record Dates

2027-02