A Phase 1, First in Human Study of TORL-4-500 in Patients With Advanced Cancer
TORL Biotherapeutics, LLC
Summary
This first-in-human study will evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of TORL-4-500 in patients with advanced cancer. For Part 1, any advanced or metastatic solid tumor malignancy will be evaluated including, for example, adrenocortical carcinoma (ACC).
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Advanced solid tumor * Measurable disease, per RECIST v1.1 * Eastern Cooperative Oncology Group (ECOG) performance status 0-1 * Adequate organ function Exclusion Criteria: * Has not recovered \[recovery is defined as NCI CTCAE, version 5.0, grade ≤1\] from the acute toxicities of previous therapy, except treatment-related alopecia or laboratory abnormalities otherwise meeting eligibility requirements * Received prior chemotherapeutic, investigational, or other therapies for the treatment of cancer within 14 days with small molecule and within 28 days with biologic befo…
Interventions
- DrugTORL-4-500
antibody drug conjugate
Locations (10)
- Mayo Clinic PhoenixPhoenix, Arizona
- Providence Medical FoundationFullerton, California
- UCLA - JCCC Clinical Research UnitLos Angeles, California
- Torrance Memorial Physician NetworkTorrance, California
- Mayo Clinic JacksonvilleJacksonville, Florida
- Florida Cancer Specialists Lake Nona Drug Development UnitOrlando, Florida