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Clinical Trials in the USA / NCT05948826
Active, not recruiting Phase 1

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

NCT05948826 · tracked via the Priya Life Science USA tracker
Sponsor
TORL Biotherapeutics, LLC
Phase
Phase 1
Started
2023-09-29
Last updated
2025-10-10

Condition(s) studied

Advanced Solid TumorColorectal Cancer

Investigational drug(s) / intervention(s)

TORL-3-600

TORL-3-600: antibody drug conjugate

Study summary

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: * Advanced solid tumor * Measurable disease, per RECIST v1.1 * Eastern Cooperative Oncology Group (ECOG) performance status 0-1 * Adequate organ function Exclusion Criteria: * 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

Primary outcome measure(s)

Trial sites (9)

FacilityCityRegionStatus
Providence Medical Foundation Fullerton California
UCLA - JCCC Clinical Research Unit Los Angeles California
Sarah Cannon Research Institute Denver Colorado
Fort Wayne Medical Oncology and Hematology Inc. Fort Wayne Indiana
Washington University School of Medicine-Siteman Cancer Center St Louis Missouri
Sarah Cannon Research Institute-Tennessee Nashville Tennessee
Mary Crowley Cancer Research Dallas Texas
University Health Network, Princess Margaret Cancer Centre Toronto Ontario
McGill University Health Centre Montreal Quebec

More TORL Biotherapeutics, LLC trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05948826 on ClinicalTrials.gov ↗ ← All trials in the USA