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NCT05103683PHASE1Recruiting

First in Human Study of TORL-1-23 in Participants With Advanced Cancer

TORL Biotherapeutics, LLC

Start Date

11/17/2021

Completion Date

11/15/2026

Summary

This first-in-human study will evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of TORL-1-23 in patients with advanced cancer

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-1-23 * 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-1-23

Interested in This Trial?

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Conditions

Advanced Solid TumorOvarian CancerEndometrial CancerNSCLC

Locations

Providence Medical Foundation

Fullerton, California 92835

United States

UCLA - JCCC Clinical Research Unit

Los Angeles, California 90095

United States

University of Kentucky Medical Center

Lexington, Kentucky 40536

United States

University of Minnesota

Minneapolis, Minnesota 55455

United States

Mayo Clinic in Rochester

Rochester, Minnesota 55905

United States

Memorial Sloan Kettering Cancer Center

New York, New York 10065

United States

Cleveland Clinic

Cleveland, Ohio 44195

United States

Sarah Cannon Research Institute Texas Oncology

Tyler, Texas 75702

United States

Virginia Cancer Specialists

Fairfax, Virginia 22031

United States

St. Vincent's Hospital, The Catholic University of Korea

Suwon, Gyeonggi-do 16247

South Korea

Seoul National University Hospital

Seoul, 03080

South Korea

Severance Hospital

Seoul, 03723

South Korea

Asan Medical Center

Seoul, 05505

South Korea

Samsung Medical Center

Seoul, 06351

South Korea