A First-in-Human, Multicenter, Phase 1/2, Open-Label Study of XTX301 in Patients With Advanced Solid Tumors
Xilio Development, Inc.
Summary
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.
Description
This is a first-in-human, multicenter, Phase 1/2, open-label study designed to evaluate the safety, tolerability, PK, PD, immunogenicity, and antitumor activity/efficacy of XTX301, a tumor-activated interleukin-12, as monotherapy in patients with advanced solid tumors. Phase 1. 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. Phase 2 will further evaluate the safety and antitumor…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: • 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 a…
Interventions
- DrugXTX301
XTX301 monotherapy
Locations (11)
- University of California, Davis Comprehensive Cancer CenterSacramento, California
- Yale Cancer CenterNew Haven, Connecticut
- HealthPartners Frauenshuh Cancer centerSaint Louis Park, Minnesota
- Washington University School of MedicineSt Louis, Missouri
- Hackensack University Medical CenterHackensack, New Jersey
- The Gabrail Pharmacology Phase 1 Research CenterCanton, Ohio