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New antibody drug conjugate tested against advanced cancers

NCT ID NCT06005740

NEW Disease control Sponsor: TORL Biotherapeutics, LLC Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 21, 2026 · Last updated Sep 21, 2026

Summary

Researchers are running a first-in-human phase 1 study of TORL-4-500, an antibody drug conjugate, in adults with advanced solid tumors, including hepatocellular carcinoma. The study has two parts: one to find the highest safe dose and the recommended dose for later trials, and another to look at how well the drug shrinks tumors. Participants receive TORL-4-500 and are monitored for side effects, tumor response, and how the body processes the drug.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
an antibody drug conjugate called TORL-4-500
What this could lead to
If it works, this could point toward a new targeted treatment option for people with advanced solid tumors, including liver cancer.
What could go wrong
This is a first-in-human phase 1 study with about 70 participants, so its main goal is safety and dosing, not proof of benefit. Many experimental cancer drugs at this stage do not move forward, and antibody drug conjugates can cause serious side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 70 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2023

Expected to finish

May 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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-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

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Conditions

The condition(s) this trial relates to.

hepatocellular carcinoma neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Advanced solid tumor Hepatocellular carcinoma

Contacts and locations

Locations

  • Florida Cancer Specialists Lake Nona Drug Development Unit

    Orlando, Florida, 32827, United States

  • Mayo Clinic Jacksonville

    Jacksonville, Florida, 32224, United States

  • Mayo Clinic Phoenix

    Phoenix, Arizona, 85054, United States

  • Mayo Clinic Rochester

    Rochester, Minnesota, 55905, United States

  • McGill University Health Centre

    Montreal, Quebec, H4A 3J1, Canada

  • Providence Medical Foundation

    Fullerton, California, 92835, United States

  • Torrance Memorial Physician Network

    Torrance, California, 90505, United States

  • UCLA - JCCC Clinical Research Unit

    Los Angeles, California, 90095, United States

  • University Health Network, Princess Margaret Cancer Centre

    Toronto, Ontario, M5G 2M9, Canada

  • Virginia Cancer Specialists

    Lexington, Virginia, 22031, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.