A Phase 1, First in Human Study of TORL-4-500 in Patients With Advanced Cancer

Recruiting now · Phase 1

Conditions studied: Advanced Solid Tumor, Hepatocellular Carcinoma

In brief

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).

Key facts

Study ID

NCT06005740

Run by

TORL Biotherapeutics, LLC

People needed

70

Starts

2023-12-04

Expected to finish

2026-10-31

Last updated by the study team

2025-03-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Advanced solid tumor
• Measurable disease, per RECIST v1.1
• Eastern Cooperative Oncology Group (ECOG) performance status 0-1
• Adequate organ function

You may not qualify if…

• 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

Where it is running

• Mayo Clinic Phoenix — Phoenix, Arizona, United States (enrolling)
• Providence Medical Foundation — Fullerton, California, United States (enrolling)
• UCLA - JCCC Clinical Research Unit — Los Angeles, California, United States (enrolling)
• Torrance Memorial Physician Network — Torrance, California, United States (enrolling)
• Mayo Clinic Jacksonville — Jacksonville, Florida, United States (enrolling)
• Florida Cancer Specialists Lake Nona Drug Development Unit — Orlando, Florida, United States (enrolling)
• Mayo Clinic Rochester — Rochester, Minnesota, United States (enrolling)
• Virginia Cancer Specialists — Lexington, Virginia, United States (enrolling)
• University Health Network, Princess Margaret Cancer Centre — Toronto, Ontario, Canada (enrolling)
• McGill University Health Centre — Montreal, Quebec, Canada (enrolling)

Full record on ClinicalTrials.gov

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