RECRUITING

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

Description

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 TumorHepatocellular Carcinoma
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Related Conditions:

Advanced Solid TumorHepatocellular Carcinoma

Study Overview

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Study Details

Study overview

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).

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

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

Condition
Advanced Solid Tumor
Intervention / Treatment

-

Contacts and Locations

Fullerton

Providence Medical Foundation, Fullerton, California, United States, 92835

Los Angeles

UCLA - JCCC Clinical Research Unit, Los Angeles, California, United States, 90095

Torrance

Torrance Memorial Physician Network, Torrance, California, United States, 90505

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

TORL Biotherapeutics, LLC,

Stephen Letrent, PharmD, PhD, STUDY_DIRECTOR, TORL Biotherapeutics, LLC

Study Record Dates

2026-10-31