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Phase 1 Study of TORL-4-500 for Advanced Cancer

This is a first-time-in-human study testing a new drug called TORL-4-500, which is an antibody drug conjugate. We are looking for people with advanced solid tumors, including hepatocellular carcinoma (a type of liver cancer). The main goals are to see how safe TORL-4-500 is, what side effects it might cause, and to find the highest dose that can be given safely. We also want to see if it has any anti-tumor activity. You may be able to join if you have an advanced solid tumor that can be measured, and good overall health. About 70 people are expected to participate.

Study design
This is a Phase 1, first-in-human study. It will include about 70 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 after treatment.

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

NCT06005740

A Phase 1, First in Human Study of TORL-4-500 in Patients With Advanced Cancer

Recruiting
PHASE1Ages 18+InterventionalTreatment
TORL Biotherapeutics, LLC
~70 participants
Updated 2025-03-04 on ClinicalTrials.gov
What's tested:TORL-4-500

At a glance

Recruiting sites
10 of 10 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
Hepatocellular Carcinoma

Explore related trials

Adrenal Cortical CarcinomaHepatocellular CarcinomaSolid Neoplasm

NCT06005740

Where you'd take part

This study runs at 10 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • UCLA - JCCC Clinical Research Unit

    Los Angeles, Californiastudy coordinator listed

    Recruiting

  • Florida Cancer Specialists Lake Nona Drug Development Unit

    Orlando, Floridano site contact published

    Recruiting

  • Mayo Clinic Jacksonville

    Jacksonville, Floridano site contact published

    Recruiting

  • Mayo Clinic Phoenix

    Phoenix, Arizonano site contact published

    Recruiting

  • Mayo Clinic Rochester

    Rochester, Minnesotano site contact published

    Recruiting

  • McGill University Health Centre

    Montreal, Quebec, Canadano site contact published

    Recruiting

  • Providence Medical Foundation

    Fullerton, Californiano site contact published

    Recruiting

  • Torrance Memorial Physician Network

    Torrance, Californiano site contact published

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Caroline Labib, PharmD · STUDY_CHAIR · TORL Biotherapeutics, LLC

Who to contact

Caroline Labib, PharmD
[email protected]
310-348-9636
Email the study team

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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-4-500
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