Recruiting
Phase 1

TORL-4-500

Sponsor:

TORL Biotherapeutics, LLC

Code:

NCT06005740

Conditions

Advanced Solid Tumor

Hepatocellular Carcinoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

TORL-4-500

Study Details

Brief 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).

Conditions

Advanced Solid Tumor

Hepatocellular Carcinoma

Study ID

NCT06005740

Start date

Dec 4, 2023

Status verified date

Oct, 2024

Completion date

Oct 31, 2026

Anticipated

Primary completion date

Oct 31, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

70 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Monotherapy Dose Dose Finding - Part 1

TORL-4-500 iv once every 3 weeks

experimental: Expansion as Monotherapy - Part 2

TORL-4-500 iv once every 3 weeks

Interventions

TORL-4-500

antibody drug conjugate

Primary outcome measure

  • Incidence and severity of adverse events and serious adverse events [ Time Frame: up to 2 years ]
  • Maximum Tolerated Dose (MTD) [ Time Frame: 28 Days ]
  • Recommended Phase 2 Dose (RP2D) [ Time Frame: up to 2 years ]

Central Contacts and Locations

Central contacts

Caroline Labib, PharmD

310-348-9636caroline.labib@torlbio.com

Locations

Mayo Clinic Phoenix

Recruiting

Phoenix, Arizona, United States, 85054

Principal Investigator:

Mohamad Sonbol, MD

Providence Medical Foundation

Recruiting

Fullerton, California, United States, 92835

UCLA - JCCC Clinical Research Unit

Recruiting

Los Angeles, California, United States, 90095

Contacts

Lee Rosen, MD

310-829-5471

Torrance Memorial Physician Network

Recruiting

Torrance, California, United States, 90505

Principal Investigator:

Justin Tiulim, MD

Mayo Clinic Jacksonville

Recruiting

Jacksonville, Florida, United States, 32224

Principal Investigator:

Yanyan Lou, MD

Florida Cancer Specialists Lake Nona Drug Development Unit

Recruiting

Orlando, Florida, United States, 32827

Principal Investigator:

Cesar Perez, MD

Mayo Clinic Rochester

Recruiting

Rochester, Minnesota, United States, 55905

Principal Investigator:

Andrea Wahner-Hendrickson, MD

Virginia Cancer Specialists

Recruiting

Lexington, Virginia, United States, 22031

University Health Network, Princess Margaret Cancer Centre

Recruiting

Toronto, Ontario, Canada, M5G 2M9

Principal Investigator:

Erica Tsang

McGill University Health Centre

Recruiting

Montréal, Quebec, Canada, H4A 3J1

Principal Investigator:

Ramy Saleh, MD

More Information

Sponsor

TORL Biotherapeutics, LLC

Last update posted

Mar 4, 2025

Last verified

Oct, 2024

Keywords

  • ADC

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by TORL Biotherapeutics, LLC on 2025-03-04.