Back to Trials
NCT06005740PHASE1Recruiting

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

TORL Biotherapeutics, LLC

Start Date

12/4/2023

Completion Date

10/31/2026

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 Criteria

Age Range: 18 years to No maximum

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

Interventions

DRUG

TORL-4-500

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

Expressing interest lets you review the study and consent before we connect you with the research site.

Conditions

Advanced Solid TumorHepatocellular Carcinoma

Locations

Mayo Clinic Phoenix

Phoenix, Arizona 85054

United States

Providence Medical Foundation

Fullerton, California 92835

United States

UCLA - JCCC Clinical Research Unit

Los Angeles, California 90095

United States

Torrance Memorial Physician Network

Torrance, California 90505

United States

Mayo Clinic Jacksonville

Jacksonville, Florida 32224

United States

Florida Cancer Specialists Lake Nona Drug Development Unit

Orlando, Florida 32827

United States

Mayo Clinic Rochester

Rochester, Minnesota 55905

United States

Virginia Cancer Specialists

Lexington, Virginia 22031

United States

University Health Network, Princess Margaret Cancer Centre

Toronto, Ontario M5G 2M9

Canada

McGill University Health Centre

Montreal, Quebec H4A 3J1

Canada