A Phase 1, Open-Label, Dose-Escalation and Expansion Study of AGX101, a TM4SF1 Directed Antibody Drug Conjugate in Patients With Unresectable, Locally Advanced, or Metastatic Solid Tumors
Angiex, Inc.
Summary
AGX101 is an antibody-drug conjugate (ADC) therapy for tumor-forming cancers. The purpose of this study is to learn about AGX101 effects and safety at various dose levels in an all-comers advanced solid cancer patient population. AGX101will be administered intravenously. Dosing of AGX101 will be repeated once every 3, 6 or 9 weeks. Participants may continue study treatment until disease progression, unacceptable toxicity, or consent withdrawal. Subjects will attend an end of treatment visit and will receive two safety follow-up telephone contacts up to 90 days following the last dose of study drug.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Histologically confirmed unresectable, locally advanced, or metastatic solid tumors. * Refractory to or relapsed after all standard therapies known to provide proven clinical benefit, unless the patient is not a candidate for standard treatment, there is no standard treatment, or the patient refuses standard treatment after expressing an understanding of all available therapies with proven clinical benefit * Willing to authorize use of existing archival tissue, unless otherwise discussed with Sponsor * Time since the last dose of prior therapy to treat underlying maligna…
Interventions
- DrugAGX101
Antibody Drug Conjugate
Locations (6)
- USC/Norris Comprehensive Cancer CenterLos Angeles, California
- Florida Cancer SpecialistSarasota, Florida
- Washington University School of MedicineSt Louis, Missouri
- Sarah Cannon Research CenterNashville, Tennessee
- NEXT OncologySan Antonio, Texas
- NEXT OncologyFairfax, Virginia