Actively Recruiting
XTX301 in Patients With Advanced Solid Tumors
Led by Xilio Development, Inc. · Updated on 2025-09-08
358
Participants Needed
11
Research Sites
194 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
XTX301 in Patients With Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- For Part 1A: Any confirmed advanced or metastatic solid tumor that has failed standard therapy or has no available standard treatment.
- For Part 1B: Confirmed advanced or metastatic melanoma, NSCLC, HNSCC, TNBC, cervical cancer, MSI-H/dMMR colorectal or endometrial cancer; possible backfill cohorts include prostate, ovarian, pancreatic cancers, microsatellite stable colorectal cancer, or T-cell lymphoma.
- For Phase 2: Measurable disease per RECIST 1.1 and disease-specific criteria for cohorts with head and neck squamous cell carcinoma, melanoma (excluding uveal), NSCLC, ovarian cancer, castrate-resistant prostate cancer, or triple-negative breast cancer.
- ECOG performance status 0-2 for Phase 1 and 0-1 for Phase 2.
- Adequate organ function.
- Willing and able to provide tumor biopsies in Part 1B.
- Fully recovered from recent major surgery without complications.
You will not qualify if you...
- Prior treatment with any form of IL-12 therapy.
- Known liver metastasis.
- Presence of ongoing necrosis areas like active ulcers, nonhealing wounds, or bone fractures.
- Active central nervous system malignancy, CNS metastases, or carcinomatous meningitis.
- Active autoimmune disease.
- History of severe immune-related adverse events from prior immunotherapy not resolved within 14 days.
- Immunodeficiency or use of high-dose immunosuppressive therapy within 7 days before study drug.
- Active hepatitis B or C infection.
- Prior gene therapy, organ transplant, or hematopoietic stem-cell transplant.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 11 locations
1
University of California, Davis Comprehensive Cancer Center
Sacramento, California, United States, 95817
Actively Recruiting
2
Yale Cancer Center
New Haven, Connecticut, United States, 06510
Actively Recruiting
3
HealthPartners Frauenshuh Cancer center
Saint Louis Park, Minnesota, United States, 55426
Actively Recruiting
4
Washington University School of Medicine
St Louis, Missouri, United States, 63110
Actively Recruiting
5
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
Actively Recruiting
6
The Gabrail Pharmacology Phase 1 Research Center
Canton, Ohio, United States, 44718
Actively Recruiting
7
University Hospital Cleveland Medical Center
Cleveland, Ohio, United States, 44106
Actively Recruiting
8
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States, 43221
Actively Recruiting
9
University of Pittsburgh Medical Center-Hillman Cancer Center
Pittsburgh, Pennsylvania, United States, 15232
Actively Recruiting
10
Tranquil Clinical Research
Webster, Texas, United States, 77598
Actively Recruiting
11
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Actively Recruiting
Research Team
X
Xilio Medical Affairs
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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