RECRUITING

First in Human Study of TORL-2-307-ADC in Participants With Advanced Cancer

Conditions

Advanced Solid Tumor Gastric Cancer Pancreas Cancer Gastroesophageal Junction Adenocarcinoma claudin18.2

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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-2-307-ADC in patients with advanced cancer

Official Title

A Phase 1, First in Human, Dose-Escalation Study of TORL-2-307-ADC in Participants With Advanced Cancer

Quick Facts

Study Start:2022-02-02

Study Completion:2026-01-15

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05156866

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-2-307-ADC * 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-2-307-ADC
* 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

Study Contact

Brandon Sookdeo

CONTACT

909-333-8966

brandon.sookdeo@torlbio.com

Principal Investigator

Stephen Letrent, PharmD, PhD

STUDY_DIRECTOR

TORL Biotherapeutics, LLC

Study Locations (Sites)

Providence St. Jude Medical Center

Fullerton, California, 92835

United States

UCLA - JCCC Clinical Research Unit

Los Angeles, California, 90095

United States

Torrance Memorial Medical

Torrance, California, 90505

United States

Fort Wayne Medical Oncology and Hematology

Fort Wayne, Indiana, 46804

United States

Washington University School of Medicine-Siteman Cancer Center

Saint Louis, Missouri, 63310

United States

START San Antonio

San Antonio, Texas, 78229

United States

Collaborators and Investigators

Sponsor: TORL Biotherapeutics, LLC

Stephen Letrent, PharmD, PhD, STUDY_DIRECTOR, 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 Date2022-02-02

Study Completion Date2026-01-15

Study Record Updates

Study Start Date2022-02-02

Study Completion Date2026-01-15

Terms related to this study

Keywords Provided by Researchers

claudin18.2

Additional Relevant MeSH Terms

Advanced Solid Tumor
Gastric Cancer
Pancreas Cancer
Gastroesophageal Junction Adenocarcinoma