Study on XTX301 for Patients with Advanced Solid Tumors
Sponsor: Xilio Development, Inc.
ClinicalTrials ID:NCT05684965
This clinical trial is testing a new drug, XTX301, to see if it is safe and well-tolerated in patients with advanced solid tumors. The study will also look at how the drug works in the body and its potential to shrink tumors.
Patient Parameters
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Program Overview
This study is the first to test XTX301, a new drug designed to activate the immune system against tumors, in humans. It will be conducted at multiple centers and is open to patients with advanced solid tumors. The study will assess the safety, how the drug is processed in the body, its effects on the immune system, and its ability to reduce tumors.
Description
The study is divided into two phases. In Phase 1, the safety and appropriate dosage of XTX301 will be determined. Initially, a small group of patients will receive increasing doses of the drug to find the safest dose. After this, more patients with specific types of advanced solid tumors will be treated to further evaluate the drug's effects on the immune system.
In Phase 2, the study will focus on specific types of cancer, including head and neck cancer, melanoma, lung cancer, ovarian cancer, prostate cancer, and triple-negative breast cancer. The goal is to see how well XTX301 works in shrinking tumors in these specific cancers. Patients will be grouped based on their type of cancer and previous treatments they have received.
Throughout the study, researchers will monitor patients for any side effects and measure how well the drug is working against the cancer. Patients will need to provide tumor samples for analysis before and after treatment.
Eligibility Criteria
Inclusion Criteria
- Have an advanced solid tumor that has not responded to standard treatments or for which no standard treatment is available.
- For Phase 2, have specific types of cancer such as head and neck cancer, melanoma, lung cancer, ovarian cancer, prostate cancer, or triple-negative breast cancer, and meet additional criteria based on previous treatments.
- Be in good overall health with an ECOG performance status of 0 to 2.
- Have adequate organ function as determined by medical tests.
- Be willing to provide tumor samples for analysis.
- Have recovered from any recent major surgery before starting the study drug.
Exclusion Criteria
- Have previously received any form of IL-12 therapy.
- Have cancer that has spread to the liver or active central nervous system cancer.
- Have any ongoing non-cancer-related wounds or bone fractures.
- Have an active autoimmune disease or a history of severe immune-related side effects from previous treatments.
- Have a diagnosis of immunodeficiency or are taking high doses of immunosuppressive medications.
- Have active hepatitis B or C infections.
- Have previously received gene therapy, organ transplant, or stem-cell transplant.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| University of California, Davis Comprehensive Cancer Center | 95817 | Sacramento | California |
| Yale Cancer Center | 06510 | New Haven | Connecticut |
| HealthPartners Frauenshuh Cancer center | 55426 | St. Louis Park | Minnesota |
| Washington University School of Medicine | 63110 | Saint Louis | Missouri |
| Hackensack University Medical Center | 07601 | Hackensack | New Jersey |
| The Gabrail Pharmacology Phase 1 Research Center | 44718 | Canton | Ohio |
| University Hospital Cleveland Medical Center | 44106 | Cleveland | Ohio |
| The Ohio State University Wexner Medical Center | 43221 | Columbus | Ohio |
| University of Pittsburgh Medical Center-Hillman Cancer Center | 15232 | Pittsburgh | Pennsylvania |
| Tranquil Clinical Research | 77598 | Webster | Texas |
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