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Recruiting Phase 1

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

NCT05103683 · tracked via the Priya Life Science USA tracker
Phase
Phase 1
Started
2021-11-17
Last updated
2026-02-13

Condition(s) studied

Advanced Solid TumorOvarian CancerEndometrial CancerNSCLC

Investigational drug(s) / intervention(s)

TORL-1-23 →

TORL-1-23: antibody drug conjugate (ADC)

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Incidence and severity of adverse events and serious adverse events — up to 2 years
    Incidence and severity of adverse events, serious adverse events, according to NCI-CTCAE Version 5.0
  • Maximum Tolerated Dose (MTD) — 28 Days
    Highest administered dose with \< 33% participants experiencing dose limiting toxicity (DLT) in the first 6 DLT evaluable participants
  • Recommended Phase 2 Dose (RP2D) — up to 2 years
    Based on the maximum tolerated dose, cumulative safety, and pharmacokinetic data

Trial sites (14)

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

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05103683 on ClinicalTrials.gov ↗ ← All trials in the USA