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
- Diseases
- Colorectal cancer
- 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
Sites (9)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| McGill University Health Centre Coordinator of this site? Confirm its status | Montreal | Canada | Unknown status |
| University Health Network - Princess Margaret Cancer Centre Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
| Mary Crowley Cancer Research Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| Sarah Cannon Research Institute Coordinator of this site? Confirm its status | Denver | United States | Unknown status |
| Fort Wayne Medical Oncology and Hematology, Inc Coordinator of this site? Confirm its status | Fort Wayne | United States | Unknown status |
| Providence Medical Foundation Coordinator of this site? Confirm its status | Fullerton | United States | Unknown status |
| UCLA - JCCC Clinical Research Unit Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| Sarah Cannon Research Institute (Tennessee) Coordinator of this site? Confirm its status | Nashville | United States | Unknown status |
| Washington University School of Medicine - Siteman Cancer Center Coordinator of this site? Confirm its status | St Louis | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.