XTX301 in Patients With Advanced Solid Tumors
ConditionAdvanced Solid Tumor
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorXilio Development, Inc.
About this trial
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.
Eligibility criteria
Qualifiers
ECOG performance status of 0-2 for Phase 1
ECOG performance status of 0 or 1 for Phase 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
Disqualifiers
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
Trial design
Treatments tested in this trial
- XTX301
Treatment groups
358 Participants
are divided into 2 treatment groupsLocations
12California
University of California, Davis Comprehensive Cancer Center95817, Sacramento United States
Connecticut
Yale Cancer Center06510, New Haven United States
Minnesota
HealthPartners Frauenshuh Cancer center55426, Saint Louis Park United States
Missouri
Washington University School of Medicine63110, St Louis United States
Sponsors and collaborators
Xilio Development, Inc.
Lead sponsor
Source ClinicalTrials.gov