ACTIVE_NOT_RECRUITING

First in Human Study of TORL-3-600 in Participants With Advanced Cancer

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This first-in-human study will evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of TORL-3-600 in patients with advanced cancer

Official Title

A Phase 1, First in Human, Dose-Escalation Study of TORL-3-600 in Participants With Advanced Cancer

Quick Facts

Study Start:2023-09-29

Study Completion:2026-09-15

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05948826

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.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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-3-600 * 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

Inclusion Criteria

Exclusion 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-3-600
* 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

Contacts and Locations

Principal Investigator

Caroline Labib, PharmD

STUDY_CHAIR

TORL Biotherapeutics, LLC

Study Locations (Sites)

Providence Medical Foundation

Fullerton, California, 92835

United States

UCLA - JCCC Clinical Research Unit

Los Angeles, California, 90095

United States

Sarah Cannon Research Institute

Denver, Colorado, 80218

United States

Fort Wayne Medical Oncology and Hematology Inc.

Fort Wayne, Indiana, 46845

United States

Washington University School of Medicine-Siteman Cancer Center

St Louis, Missouri, 63110

United States

Sarah Cannon Research Institute-Tennessee

Nashville, Tennessee, 37203

United States

Mary Crowley Cancer Research

Dallas, Texas, 75230

United States

Collaborators and Investigators

Sponsor: TORL Biotherapeutics, LLC

Caroline Labib, PharmD, STUDY_CHAIR, 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 Registration Dates

Study Start Date2023-09-29

Study Completion Date2026-09-15

Study Record Updates

Study Start Date2023-09-29

Study Completion Date2026-09-15

Terms related to this study

Additional Relevant MeSH Terms

Advanced Solid Tumor
Colorectal Cancer