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
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