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
52 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
Researchers are evaluating TORL-4-500, an antibody drug conjugate, in adults with advanced or metastatic solid tumors, including hepatocellular carcinoma and adrenocortical carcinoma, in this first-in-human Phase 1 study. The trial aims to assess the safety, tolerability, how the drug moves through the body, and its antitumor effects in patients with advanced cancer. Participants receive TORL-4-500 intravenously once every three weeks. The study includes two parts: Part 1 focuses on dose finding to determine the maximum tolerated dose and recommended dose for future studies. Part 2 expands on this by further assessing the drug as a monotherapy at the selected dose. During the study, participants will have regular evaluations for side effects and serious adverse events up to two years. Researchers will monitor tumor response, duration of response, progression-free survival, and overall survival. Blood samples will be taken to measure drug levels and immune response. The total study duration varies, with some assessments occurring up to two years after treatment begins to ensure thorough safety and effectiveness monitoring.
CONDITIONS
Brief 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, per RECIST v1.1
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Adequate organ function
You will not qualify if you...
- Has not recovered [recovery is defined as NCI CTCAE, version 5.0, grade 41] from acute toxicities of previous therapy, except treatment-related alopecia or laboratory abnormalities otherwise meeting eligibility
- Received prior chemotherapeutic, investigational, or other therapies for cancer within 14 days (small molecule) or 28 days (biologic) 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 (MDS) or acute myeloid leukemia (AML)
- History of another cancer within 3 years before Day 1, except treated basal or squamous cell carcinoma of the skin or low-risk malignancies like treated DCIS or low-Gleason prostate cancer
- Pregnant or breastfeeding females
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated 21-day cycles until disease progression or discontinuation
Participants receive TORL-4-500 as an intravenous infusion once every 3 weeks to treat advanced cancer.
Infusions every 3 weeks during treatment
Duration - Up to 2 years
Participants are monitored for safety and treatment effects for up to 2 years after treatment ends.
Periodic follow-up visits up to 2 years
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
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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