First in Human Study of TORL-3-600 in Participants With Advanced Cancer

Running, not enrolling · Phase 1

Conditions studied: Advanced Solid Tumor, Colorectal Cancer

In brief

This first-in-human study will evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of TORL-3-600 in patients with advanced cancer

Key facts

Study ID

NCT05948826

Run by

TORL Biotherapeutics, LLC

People needed

70

Starts

2023-09-29

Expected to finish

2026-09-15

Last updated by the study team

2025-10-10

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-3-600
• 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

• Providence Medical Foundation — Fullerton, California, United States
• UCLA - JCCC Clinical Research Unit — Los Angeles, California, United States
• Sarah Cannon Research Institute — Denver, Colorado, United States
• Fort Wayne Medical Oncology and Hematology Inc. — Fort Wayne, Indiana, United States
• Washington University School of Medicine-Siteman Cancer Center — St Louis, Missouri, United States
• Sarah Cannon Research Institute-Tennessee — Nashville, Tennessee, United States
• Mary Crowley Cancer Research — Dallas, Texas, United States
• University Health Network, Princess Margaret Cancer Centre — Toronto, Ontario, Canada
• McGill University Health Centre — Montreal, Quebec, Canada

Full record on ClinicalTrials.gov

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