XTX301 in Patients With Advanced Solid Tumors
a study on Solid Tumor Neoplasms
Summary
- Eligibility
- for people ages 18 years and up (full criteria)
- Location
- at UC Davis
- Dates
- study startedestimated completion
Description
Summary
This is a first-in-human, multicenter, Phase 1, 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, Open-Label Study of XTX301 in Patients With Advanced Solid Tumors
Details
This is a first-in-human, multicenter, Phase 1, open-label study designed to evaluate the safety, tolerability, PK, PD, immunogenicity, and efficacy of XTX301, a tumor-activated interleukin-12, as monotherapy in patients with advanced solid tumors.
Part 1A will examine XTX301 monotherapy in a standard 3+3 dose escalation design. Based on the results of Part 1A, patients with select advanced solid tumors will be enrolled in Part 1B, which will evaluate XTX301 monotherapy in relation to specific PD biomarkers.
Keywords
Advanced Solid Tumor, Neoplasms, XTX301, XTX301 Monotherapy in Select Tumor Types
Eligibility
You can join if…
Open to people ages 18 years and up
• Disease Criteria: Part 1A - Any histologically or cytologically confirmed solid tumor malignancy that is locally advanced or metastatic and has failed standard therapy, standard therapy does not confer survival benefit, or standard therapy is not available.
Part 1B- Any histologically or cytologically confirmed solid tumor malignancy among the tumor types outlined below, that is locally advanced or metastatic and has failed standard therapy, standard therapy does not confer survival benefit, or standard therapy is not available. Patients with the following tumor types are eligible for Part 1B: melanoma, non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma, triple-negative breast cancer (TNBC), MSI-H/dMMR colorectal cancer, MSI-H/dMMR endometrial cancer, prostate cancer, ovarian cancer, pancreatic cancer, and microsatellite stable colorectal cancer.
- ECOG performance status of 0-2
- Adequate organ function
- Tumor tissue samples: Part 1A: archival tumor tissue available or provide a fresh tumor biopsy. 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
You CAN'T join if...
- 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
Locations
- University of California, Davis Comprehensive Cancer Center
accepting new patients
Sacramento California 95817 United States - Tranquil Clinical Research
accepting new patients
Webster Texas 77598 United States
Details
- Status
- accepting new patients
- Start Date
- Completion Date
- (estimated)
- Sponsor
- Xilio Development, Inc.
- ID
- NCT05684965
- Phase
- Phase 1 research study
- Study Type
- Interventional
- Participants
- Expecting 94 study participants
- Last Updated