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NCT05948826Active, not recruitingPhase 1

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

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

Source: ClinicalTrials.gov · Last updated 10 Oct 2025

Brief summary (registry, in English)

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

Status (registry)
Active, not recruiting
Phase (registry)
Phase 1
Study type
Interventional
Enrollment
70 (estimated)
First submitted
9 Jul 2023
Start date
29 Sept 2023
Primary completion date
25 Jun 2026
Lead sponsor
TORL Biotherapeutics, LLC
NCT number
NCT05948826

What you commit to

  • Study type: Interventional · Phase 1
  • Planned participants: 70
  • From 29 Sept 2023 to the primary completion date, 25 Jun 2026
  • 9 sites in 2 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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

Other illness

  • 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

Lab values

  • 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

Other

  • Progressive or symptomatic brain metastases
  • If female, is pregnant or breastfeeding

Who the study is looking for

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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (9)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
McGill University Health Centre
Coordinator of this site? Confirm its status
MontrealCanadaUnknown status
University Health Network - Princess Margaret Cancer Centre
Coordinator of this site? Confirm its status
TorontoCanadaUnknown status
Mary Crowley Cancer Research
Coordinator of this site? Confirm its status
DallasUnited StatesUnknown status
Sarah Cannon Research Institute
Coordinator of this site? Confirm its status
DenverUnited StatesUnknown status
Fort Wayne Medical Oncology and Hematology, Inc
Coordinator of this site? Confirm its status
Fort WayneUnited StatesUnknown status
Providence Medical Foundation
Coordinator of this site? Confirm its status
FullertonUnited StatesUnknown status
UCLA - JCCC Clinical Research Unit
Coordinator of this site? Confirm its status
Los AngelesUnited StatesUnknown status
Sarah Cannon Research Institute (Tennessee)
Coordinator of this site? Confirm its status
NashvilleUnited StatesUnknown status
Washington University School of Medicine - Siteman Cancer Center
Coordinator of this site? Confirm its status
St LouisUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.