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First-in-Human Study of TORL-1-23 for Advanced Cancer

This study is testing a new treatment called TORL-1-23, which is an antibody drug conjugate (a type of targeted therapy), for people with advanced solid tumors, including ovarian cancer, endometrial cancer, and non-small cell lung cancer (NSCLC). This is the first time TORL-1-23 is being given to people. The main goals are to see how safe TORL-1-23 is, what side effects it might cause, and to find the best dose to use in future studies. We are also looking to see if it has any anti-tumor activity. You might be able to join if you have an advanced solid tumor that can be measured, and you are generally well enough to participate. The study is currently recruiting about 90 participants.

Study design
This is a first-in-human study, meaning it's the first time this treatment is being tested in people. It aims to enroll about 90 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Your safety will be monitored for up to 2 years, and the recommended dose will be determined within 2 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05103683

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
TORL Biotherapeutics, LLC
~90 participants
Updated 2026-02-13 on ClinicalTrials.gov
What's tested:TORL-1-23

At a glance

Recruiting sites
14 of 14 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence and severity of adverse events and serious adverse events
Measured over up to 2 years
+2 more outcomes measured

Conditions

Advanced Solid Tumor
Ovarian Cancer
Endometrial Cancer
NSCLC

Explore related trials

Endometrial CarcinomaLung Non-Small Cell CarcinomaMalignant Ovarian NeoplasmSolid NeoplasmCLDN6 Gene

Where it's being run

14 sites across 9 states
South Korea4
California2
Minnesota2
Kentucky1
New York1
Ohio1
Texas1
Virginia1

Study leadership

  • Nora Ku, MD · STUDY_CHAIR · TORL Biotherapeutics, LLC

Who to contact

Nora Ku, MD
[email protected]
310-348-9636
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Advanced solid tumor
Measurable disease, per RECIST v1.1
Eastern Cooperative Oncology Group (ECOG) performance status 0-1
Adequate organ function

Exclusion

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

What this trial measures

  • Incidence and severity of adverse events and serious adverse eventsup 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