Status:
RECRUITING
A Phase 1, First in Human Study of TORL-4-500 in Patients With Advanced Cancer
Lead Sponsor:
TORL Biotherapeutics, LLC
Collaborating Sponsors:
Translational Research in Oncology
Conditions:
Advanced Solid Tumor
Hepatocellular Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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...
Eligibility Criteria
Inclusion
- Advanced solid tumor
- Measurable disease, per RECIST v1.1
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Adequate organ function
Exclusion
- 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 before the first dose of TORL-4-500
- 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 AML
- History of another cancer within 3 years before Day 1 of study treatment, with the exception of basal or squamous cell carcinoma of the skin that has been definitively treated. A history of other malignancies with a low risk of recurrence, including appropriately treated ductal carcinoma in situ (DCIS) of the breast and prostate cancer with a Gleason score less than or equal to 6, are also not excluded
- If female, is pregnant or breastfeeding
Key Trial Info
Start Date :
December 4 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 31 2026
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT06005740
Start Date
December 4 2023
End Date
October 31 2026
Last Update
March 4 2025
Active Locations (10)
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1
Mayo Clinic Phoenix
Phoenix, Arizona, United States, 85054
2
Providence Medical Foundation
Fullerton, California, United States, 92835
3
UCLA - JCCC Clinical Research Unit
Los Angeles, California, United States, 90095
4
Torrance Memorial Physician Network
Torrance, California, United States, 90505