Advanced Solid TumorPhase 1NCT06005740

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

A Phase 1 study testing TORL-4-500 in people with Advanced Solid Tumor and Hepatocellular Carcinoma, run by TORL Biotherapeutics, LLC at 10 sites in 2 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

This first-in-human study will evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of TORL-4-500 in patients with advanced cancer. For Part 1, any advanced or metastatic solid tumor malignancy will be evaluated including, for example, adrenocortical carcinoma (ACC). Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Advanced Solid Tumor, Hepatocellular Carcinoma
What is being tested?: TORL-4-500
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 70 participants
Where: 10 sitesin 2 countries
Study dates: 4 Dec 2023to 31 May 2027
Phase: Phase 1

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

10 sites in 2 countries.

Country

City, postcode or hospital

10 sites in 2 countries

United States8 sites

Providence Medical Foundation
Fullerton, California, 92835
Mayo Clinic Jacksonville
Jacksonville, Florida, 32224
Virginia Cancer Specialists
Lexington, Virginia, 22031
UCLA - JCCC Clinical Research Unit
Los Angeles, California, 90095
Florida Cancer Specialists Lake Nona Drug Development Unit
Orlando, Florida, 32827
Mayo Clinic Phoenix
Phoenix, Arizona, 85054
Mayo Clinic Rochester
Rochester, Minnesota, 55905
Torrance Memorial Physician Network
Torrance, California, 90505

Other trials in United States

Canada2 sites

McGill University Health Centre
Montreal, Quebec, H4A 3J1
University Health Network, Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2M9

Other trials in Canada

About this study

This first-in-human study will evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of TORL-4-500 in patients with advanced cancer.

For Part 1, any advanced or metastatic solid tumor malignancy will be evaluated including, for example, adrenocortical carcinoma (ACC).

Conditions: Advanced Solid Tumor, Hepatocellular Carcinoma
Being tested: TORL-4-500
Keywords: ADC
Medical subject headings: Carcinoma, Hepatocellular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

TORL-4-500Drug
antibody drug conjugate

Study groups in NCT06005740
Study group	Role	What they receive
Monotherapy Dose Dose Finding - Part 1	Experimental	TORL-4-500 iv once every 3 weeks Receives: Drug: TORL-4-500
Expansion as Monotherapy - Part 2	Experimental	TORL-4-500 iv once every 3 weeks Receives: Drug: TORL-4-500

What is being measured

The primary outcome is the main question the study is designed to answer.

Incidence and severity of adverse events and serious adverse events
Incidence and severity of adverse events, serious adverse events, according to NCI-CTCAE Version 5.0
Measured: up to 2 years
Maximum Tolerated Dose (MTD)
Highest administered dose with < 33% participants experiencing dose limiting toxicity (DLT) in the first 6 DLT evaluable participants
Measured: 28 Days
Recommended Phase 2 Dose (RP2D)
Based on the maximum tolerated dose, cumulative safety, and pharmacokinetic data
Measured: up to 2 years

Secondary outcomes (20)

Objective Response Rate (ORR)
Percentage of participants with best response of complete response (CR) or partial response (PR) according to RECIST 1.1
Measured: up to 2 years
Duration of Response (DOR)
Time from CR or PR to objective disease progression or death to any cause
Measured: up to 2 years
Progression Free Survival (PFS)
PFS is defined as the time from the start of the treatment until objective disease progression or death from any cause
Measured: up to 2 years
Time to Response (TTR)
Time from start of treatment to complete response or partial response
Measured: up to 2 years
1 Year Overall Survival (1YOS)
Proportion of participants alive at 1 year from the start of treatment to death from any cause
Measured: 1 year
2 Year Overall Survival (2YOS)
Proportion of participants alive at 2 years from the start of treatment to death from any cause
Measured: 2 years
Number of anti-drug antibody (ADA) Positive Participants
Immunogenicity will be measured by the number of participants that are ADA positive.
Measured: up to 2 years
Maximum Serum Concentration of TORL-4-500 (Cmax)
PK assessment
Measured: 21 days
Minimum Serum Concentration of TORL-4-500 (Cmin)
PK assessment
Measured: 21 days
Maximum Serum Concentration of TORL-4-500 at Steady State (Cmax,ss)
PK assessment
Measured: 63 days
Minimum Serum Concentration of TORL-4-500 at Steady State (Cmin,ss)
PK assessment
Measured: 63 days
Time of Maximum Serum Concentration of TORL-4-500 (Tmax)
PK assessment
Measured: 21 days
Time of Minimum Serum Concentration of TORL-4-500 (Tmin)
PK Assessment
Measured: 21 days
Time of Minimum Serum Concentration of TORL-4-500 at Steady State (Tmin,ss)
PK Assessment
Measured: 63 days
Terminal Half-life (t1/2) of Serum TORL-4-500-ADC
PK Assessment
Measured: 63 days
Area under the Serum Concentration-Time curve from the time of dosing to the last measurable concentration (AUClast) for TORL-4-500
PK Assessment
Measured: 21 days
Area under the Serum Concentration-Time curve from the time of dosing extrapolated to time infinity (AUCinf) for TORL-4-500
PK Assessment
Measured: 63 days
Apparent volume of distribution during the terminal phase (Vz) of TORL-4-500
PK Assessment
Measured: 63 days
Clearance (CL) of TORL-4-500
PK Assessment
Measured: 63 days
Accumulation ratio (Rac) of TORL-4-500
PK Assessment
Measured: 63 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

4 Dec 202331 May 2027

First posted22 Aug 2023
Study start4 Dec 2023
Primary completion29 Mar 2027 (estimated)
Study completion31 May 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Advanced Solid TumorStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Enrolment: 70 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06005740
Sponsor's protocol ID: TORL4500-001
Status last verified: Sep 2026
First submitted: 15 Aug 2023
Last updated: 21 Sep 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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