Clinical Trials in the USA / NCT05103683
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
Condition(s) studied
Advanced Solid TumorOvarian CancerEndometrial CancerNSCLC
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
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)
| Facility | City | Region | Status |
|---|---|---|---|
| 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 |
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Other trials for the same condition
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