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

NCT06005740 | Active Not Recruiting Phase 1 FDA Drug

• 1 other identifier: TORL4500-001
• Study Type: interventional
• Target: 70
• Locations: 2 countries
• Sites: 10

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

Keywords

ADC

Outcome Measures

Primary Outcomes (3)

• 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

  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

  28 Days

• Recommended Phase 2 Dose (RP2D)

  Based on the maximum tolerated dose, cumulative safety, and pharmacokinetic data

  up to 2 years

Secondary Outcomes (20)

• Objective Response Rate (ORR)

  up to 2 years

• Duration of Response (DOR)

  up to 2 years

• Progression Free Survival (PFS)

  up to 2 years

• Time to Response (TTR)

  up to 2 years

• 1 Year Overall Survival (1YOS)

  1 year

Study Arms (2)

Monotherapy Dose Dose Finding - Part 1

EXPERIMENTAL

TORL-4-500 iv once every 3 weeks

Drug: TORL-4-500

Expansion as Monotherapy - Part 2

EXPERIMENTAL

TORL-4-500 iv once every 3 weeks

Drug: TORL-4-500

Interventions

TORL-4-500 DRUG

antibody drug conjugate

Expansion as Monotherapy - Part 2; Monotherapy Dose Dose Finding - Part 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• TORL Biotherapeutics, LLC: lead
• Translational Research in Oncology: collaborator

Study Sites (10)

Mayo Clinic Phoenix

Phoenix, Arizona, 85054, United States

Location

Providence Medical Foundation

Fullerton, California, 92835, United States

Location

UCLA - JCCC Clinical Research Unit

Los Angeles, California, 90095, United States

Location

Torrance Memorial Physician Network

Torrance, California, 90505, United States

Location

Mayo Clinic Jacksonville

Jacksonville, Florida, 32224, United States

Location

Florida Cancer Specialists Lake Nona Drug Development Unit

Orlando, Florida, 32827, United States

Location

Mayo Clinic Rochester

Rochester, Minnesota, 55905, United States

Location

Virginia Cancer Specialists

Lexington, Virginia, 22031, United States

Location

University Health Network, Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2M9, Canada

Location

McGill University Health Centre

Montreal, Quebec, H4A 3J1, Canada

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• Caroline Labib, PharmD

  TORL Biotherapeutics, LLC

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 15, 2023
• First Posted: August 22, 2023
• Study Start: December 4, 2023
• Primary Completion (Estimated): March 29, 2027
• Study Completion (Estimated): May 31, 2027
• Last Updated: September 21, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2); US (8)