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

February 27, 2025 updated by: TORL Biotherapeutics, LLC

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
70

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 2M9
        • Recruiting
        • University Health Network, Princess Margaret Cancer Centre
        • Contact:
          • Erica Tsang
    • Quebec
      • Montréal, Quebec, Canada, H4A 3J1
        • Recruiting
        • McGill University Health Centre
        • Contact:
          • Ramy Saleh, MD
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85054
        • Recruiting
        • Mayo Clinic Phoenix
        • Contact:
          • Mohamad Sonbol, MD
    • California
      • Fullerton, California, United States, 92835
        • Recruiting
        • Providence Medical Foundation
        • Contact:
          • Yung Lyou, MD
      • Los Angeles, California, United States, 90095
        • Recruiting
        • UCLA - JCCC Clinical Research Unit
        • Contact:
          • Lee Rosen, MD
          • Phone Number: 310-829-5471
      • Torrance, California, United States, 90505
        • Recruiting
        • Torrance Memorial Physician Network
        • Contact:
          • Justin Tiulim, MD
    • Florida
      • Jacksonville, Florida, United States, 32224
        • Recruiting
        • Mayo Clinic Jacksonville
        • Contact:
          • Yanyan Lou, MD
      • Orlando, Florida, United States, 32827
        • Recruiting
        • Florida Cancer Specialists Lake Nona Drug Development Unit
        • Contact:
          • Cesar Perez, MD
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Recruiting
        • Mayo Clinic Rochester
        • Contact:
          • Andrea Wahner-Hendrickson, MD
    • Virginia
      • Lexington, Virginia, United States, 22031
        • Recruiting
        • Virginia Cancer Specialists
        • Contact:
          • Alexander Spira, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Monotherapy Dose Dose Finding - Part 1
TORL-4-500 iv once every 3 weeks
Drug: TORL-4-500
antibody drug conjugate
Experimental: Expansion as Monotherapy - Part 2
TORL-4-500 iv once every 3 weeks
Drug: TORL-4-500
antibody drug conjugate

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Incidence and severity of adverse events and serious adverse events
Time Frame: up to 2 years
Incidence and severity of adverse events, serious adverse events, according to NCI-CTCAE Version 5.0
up to 2 years
Maximum Tolerated Dose (MTD)
Time Frame: 28 Days
Highest administered dose with < 33% participants experiencing dose limiting toxicity (DLT) in the first 6 DLT evaluable participants
28 Days
Recommended Phase 2 Dose (RP2D)
Time Frame: up to 2 years
Based on the maximum tolerated dose, cumulative safety, and pharmacokinetic data
up to 2 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Objective Response Rate (ORR)
Time Frame: up to 2 years
Percentage of participants with best response of complete response (CR) or partial response (PR) according to RECIST 1.1
up to 2 years
Duration of Response (DOR)
Time Frame: up to 2 years
Time from CR or PR to objective disease progression or death to any cause
up to 2 years
Progression Free Survival (PFS)
Time Frame: up to 2 years
PFS is defined as the time from the start of the treatment until objective disease progression or death from any cause
up to 2 years
Time to Response (TTR)
Time Frame: up to 2 years
Time from start of treatment to complete response or partial response
up to 2 years
1 Year Overall Survival (1YOS)
Time Frame: 1 year
Proportion of participants alive at 1 year from the start of treatment to death from any cause
1 year
2 Year Overall Survival (2YOS)
Time Frame: 2 years
Proportion of participants alive at 2 years from the start of treatment to death from any cause
2 years
Number of anti-drug antibody (ADA) Positive Participants
Time Frame: up to 2 years
Immunogenicity will be measured by the number of participants that are ADA positive.
up to 2 years
Maximum Serum Concentration of TORL-4-500 (Cmax)
Time Frame: 21 days
PK assessment
21 days
Minimum Serum Concentration of TORL-4-500 (Cmin)
Time Frame: 21 days
PK assessment
21 days
Maximum Serum Concentration of TORL-4-500 at Steady State (Cmax,ss)
Time Frame: 63 days
PK assessment
63 days
Minimum Serum Concentration of TORL-4-500 at Steady State (Cmin,ss)
Time Frame: 63 days
PK assessment
63 days
Time of Maximum Serum Concentration of TORL-4-500 (Tmax)
Time Frame: 21 days
PK assessment
21 days
Time of Minimum Serum Concentration of TORL-4-500 (Tmin)
Time Frame: 21 days
PK Assessment
21 days
Time of Minimum Serum Concentration of TORL-4-500 at Steady State (Tmin,ss)
Time Frame: 63 days
PK Assessment
63 days
Terminal Half-life (t1/2) of Serum TORL-4-500-ADC
Time Frame: 63 days
PK Assessment
63 days
Apparent volume of distribution during the terminal phase (Vz) of TORL-4-500
Time Frame: 63 days
PK Assessment
63 days
Clearance (CL) of TORL-4-500
Time Frame: 63 days
PK Assessment
63 days
Accumulation ratio (Rac) of TORL-4-500
Time Frame: 63 days
PK Assessment
63 days
Area under the Serum Concentration-Time curve from the time of dosing to the last measurable concentration (AUClast) for TORL-4-500
Time Frame: 21 days
PK Assessment
21 days
Area under the Serum Concentration-Time curve from the time of dosing extrapolated to time infinity (AUCinf) for TORL-4-500
Time Frame: 63 days
PK Assessment
63 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
TORL Biotherapeutics, LLC

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Translational Research in Oncology

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Caroline Labib, PharmD, TORL Biotherapeutics, LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 4, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 31, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 31, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 15, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 15, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 22, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 27, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TORL4500-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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