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First in Human Study of TORL-1-23 in Participants With Advanced Cancer
RecruitingPhase 1
A Phase 1, First in Human, Dose-Escalation Study of TORL-1-23 in Participants With Advanced Cancer
Who can join
Ages 18 and older · All sexes
Full eligibility criteria
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
About the study
This first-in-human study will evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of TORL-1-23 in patients with advanced cancer
What is being tested
- TORL-1-23 (drug)
Sponsor: TORL Biotherapeutics, LLC · Participants: 90 · Started: Nov 17, 2021
Contact the study team
- Nora Ku, MD · Phone: 310-348-9636
- Ibrahim Qazi · Phone: 310-348-9636
Official record on ClinicalTrials.gov — NCT05103683
Locations in the U.S.
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.