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

Recruiting now · Phase 1

Conditions studied: Advanced Solid Tumor, Ovarian Cancer, Endometrial Cancer, NSCLC

In brief

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

Key facts

Study ID

NCT05103683

Run by

TORL Biotherapeutics, LLC

People needed

90

Starts

2021-11-17

Expected to finish

2026-11-15

Last updated by the study team

2026-02-13

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-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

Where it is running

• Providence Medical Foundation — Fullerton, California, United States (enrolling)
• UCLA - JCCC Clinical Research Unit — Los Angeles, California, United States (enrolling)
• University of Kentucky Medical Center — Lexington, Kentucky, United States (enrolling)
• University of Minnesota — Minneapolis, Minnesota, United States (enrolling)
• Mayo Clinic in Rochester — Rochester, Minnesota, United States (enrolling)
• Memorial Sloan Kettering Cancer Center — New York, New York, United States (enrolling)
• Cleveland Clinic — Cleveland, Ohio, United States (enrolling)
• Sarah Cannon Research Institute Texas Oncology — Tyler, Texas, United States (enrolling)
• Virginia Cancer Specialists — Fairfax, Virginia, United States (enrolling)
• St. Vincent's Hospital, The Catholic University of Korea — Suwon, Gyeonggi-do, South Korea (enrolling)
• Seoul National University Hospital — Seoul, South Korea (enrolling)
• Severance Hospital — Seoul, South Korea (enrolling)
• Asan Medical Center — Seoul, South Korea (enrolling)
• Samsung Medical Center — Seoul, South Korea (enrolling)

Full record on ClinicalTrials.gov

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