Actively Recruiting
A Phase 1, First in Human Study of TORL-4-500 in Patients With Advanced Cancer
Led by TORL Biotherapeutics, LLC · Updated on 2025-03-04
70
Participants Needed
10
Research Sites
151 weeks
Total Duration
On this page
Sponsors
T
TORL Biotherapeutics, LLC
Lead Sponsor
T
Translational Research in Oncology
Collaborating Sponsor
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
A Phase 1, First in Human Study of TORL-4-500 in Patients With Advanced Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Advanced solid tumor
- Measurable disease according to RECIST v1.1
- ECOG performance status of 0 or 1
- Adequate organ function
You will not qualify if you...
- Not recovered from acute toxicities of previous therapy except treatment-related hair loss or eligible lab abnormalities
- Received chemotherapeutic, investigational, or other cancer therapies within 14 days for small molecules or 28 days for biologics before first dose
- Progressive or symptomatic brain metastases
- Serious uncontrolled medical disorder, nonmalignant systemic disease, or active uncontrolled infection
- History of significant cardiac disease
- History of myelodysplastic syndrome or acute myeloid leukemia
- History of another cancer within 3 years before study treatment except definitively treated basal or squamous cell skin cancer
- Pregnant or breastfeeding if female
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 10 locations
1
Mayo Clinic Phoenix
Phoenix, Arizona, United States, 85054
Actively Recruiting
2
Providence Medical Foundation
Fullerton, California, United States, 92835
Actively Recruiting
3
UCLA - JCCC Clinical Research Unit
Los Angeles, California, United States, 90095
Actively Recruiting
4
Torrance Memorial Physician Network
Torrance, California, United States, 90505
Actively Recruiting
5
Mayo Clinic Jacksonville
Jacksonville, Florida, United States, 32224
Actively Recruiting
6
Florida Cancer Specialists Lake Nona Drug Development Unit
Orlando, Florida, United States, 32827
Actively Recruiting
7
Mayo Clinic Rochester
Rochester, Minnesota, United States, 55905
Actively Recruiting
8
Virginia Cancer Specialists
Lexington, Virginia, United States, 22031
Actively Recruiting
9
University Health Network, Princess Margaret Cancer Centre
Toronto, Ontario, Canada, M5G 2M9
Actively Recruiting
10
McGill University Health Centre
Montreal, Quebec, Canada, H4A 3J1
Actively Recruiting
Research Team
C
Caroline Labib, PharmD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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