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 groupsSponsors and collaborators
Source ClinicalTrials.gov