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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

Full criteria on ClinicalTrials.gov

Sites (12)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Seoul National University Hospital
Coordinator of this site? Confirm its status
SeoulSouth KoreaUnknown status
Severance Hospital, Yonsei University Health System
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SeoulSouth KoreaUnknown status
Seoul National University Bundang Hospital
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SeoulSouth KoreaUnknown status
Texas Oncology - Austin
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AustinUnited StatesUnknown status
Texas Oncology - Dallas
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DallasUnited StatesUnknown status
Fort Wayne Medical Oncology and Hematology
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Fort WayneUnited StatesUnknown status
Providence St. Jude Medical Center
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FullertonUnited StatesUnknown status
UCLA - JCCC Clinical Research Unit
Coordinator of this site? Confirm its status
Los AngelesUnited StatesUnknown status
START | San Antonio
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San AntonioUnited StatesUnknown status
Washington University School of Medicine - Siteman Cancer Center
Coordinator of this site? Confirm its status
St LouisUnited StatesUnknown status
Torrance Memorial Medical
Coordinator of this site? Confirm its status
TorranceUnited StatesUnknown status
Texas Oncology - Tyler
Coordinator of this site? Confirm its status
TylerUnited StatesUnknown status

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