NCT05156866Active, not recruitingPhase 1
First in Human Study of TORL-2-307-ADC in Participants With Advanced Cancer
A Phase 1, First in Human, Dose-Escalation Study of TORL-2-307-ADC in Participants With Advanced Cancer
Source: ClinicalTrials.gov · Last updated 13 Jan 2026
Brief summary (registry, in English)
This first-in-human study will evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of TORL-2-307-ADC in patients with advanced cancer
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 163 (actual)
- First submitted
- 1 Dec 2021
- Start date
- 2 Feb 2022
- Primary completion date
- 15 Jun 2026
- Lead sponsor
- TORL Biotherapeutics, LLC
- NCT number
- NCT05156866
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 163
- From 2 Feb 2022 to the primary completion date, 15 Jun 2026
- 12 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-2-307-ADC
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 (12)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Seoul National University Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Severance Hospital, Yonsei University Health System Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Seoul National University Bundang Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Texas Oncology - Austin Coordinator of this site? Confirm its status | Austin | United States | Unknown status |
| Texas Oncology - Dallas Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| Fort Wayne Medical Oncology and Hematology Coordinator of this site? Confirm its status | Fort Wayne | United States | Unknown status |
| Providence St. Jude Medical Center 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 |
| START | San Antonio Coordinator of this site? Confirm its status | San Antonio | 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 |
| Torrance Memorial Medical Coordinator of this site? Confirm its status | Torrance | United States | Unknown status |
| Texas Oncology - Tyler Coordinator of this site? Confirm its status | Tyler | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.