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

Running, not enrolling · Phase 1

Conditions studied: Advanced Solid Tumor, Gastric Cancer, Pancreas Cancer, Gastroesophageal Junction Adenocarcinoma

In brief

This first-in-human study will evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of TORL-2-307-ADC in patients with advanced cancer

Key facts

Study ID

NCT05156866

Run by

TORL Biotherapeutics, LLC

People needed

163

Starts

2022-02-02

Expected to finish

2027-02-15

Last updated by the study team

2026-01-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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-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

Where it is running

• Providence St. Jude Medical Center — Fullerton, California, United States
• UCLA - JCCC Clinical Research Unit — Los Angeles, California, United States
• Torrance Memorial Medical — Torrance, California, United States
• Fort Wayne Medical Oncology and Hematology — Fort Wayne, Indiana, United States
• Washington University School of Medicine-Siteman Cancer Center — St Louis, Missouri, United States
• Texas Oncology-Austin — Austin, Texas, United States
• Texas Oncology-Dallas — Dallas, Texas, United States
• START San Antonio — San Antonio, Texas, United States
• Texas Oncology-Tyler — Tyler, Texas, United States
• Seoul National University Hospital — Seoul, South Korea
• Severance Hospital, Yonsei University Health System — Seoul, South Korea
• Seoul National University Bundang Hospital — Seoul, South Korea

Full record on ClinicalTrials.gov

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