A Phase 1, First in Human Study of TORL-4-500 in Patients With Advanced Cancer
Status: Recruiting
Location: See all (10) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Advanced solid tumor
• Measurable disease, per RECIST v1.1
• Eastern Cooperative Oncology Group (ECOG) performance status 0-1
• Adequate organ function
Locations
United States
Arizona
Mayo Clinic Phoenix
RECRUITING
Phoenix
California
Providence Medical Foundation
RECRUITING
Fullerton
UCLA - JCCC Clinical Research Unit
RECRUITING
Los Angeles
Torrance Memorial Physician Network
RECRUITING
Torrance
Florida
Mayo Clinic Jacksonville
RECRUITING
Jacksonville
Florida Cancer Specialists Lake Nona Drug Development Unit
RECRUITING
Orlando
Minnesota
Mayo Clinic Rochester
RECRUITING
Rochester
Virginia
Virginia Cancer Specialists
RECRUITING
Lexington
Other Locations
Canada
McGill University Health Centre
RECRUITING
Montreal
University Health Network, Princess Margaret Cancer Centre
RECRUITING
Toronto
Contact Information
Primary
Caroline Labib, PharmD
caroline.labib@torlbio.com
310-348-9636
Time Frame
Start Date: 2023-12-04
Estimated Completion Date: 2026-10-31
Participants
Target number of participants: 70
Treatments
Experimental: Monotherapy Dose Dose Finding - Part 1
TORL-4-500 iv once every 3 weeks
Experimental: Expansion as Monotherapy - Part 2
TORL-4-500 iv once every 3 weeks
Related Therapeutic Areas
Sponsors
Collaborators: Translational Research in Oncology
Leads: TORL Biotherapeutics, LLC