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Clinical Trials in the USA / NCT05156866
Active, not recruiting Phase 1

First in Human Study of TORL-2-307-ADC in Participants With Advanced Cancer

NCT05156866 · tracked via the Priya Life Science USA tracker
Sponsor
TORL Biotherapeutics, LLC
Phase
Phase 1
Started
2022-02-02
Last updated
2026-01-13

Condition(s) studied

Advanced Solid TumorGastric CancerPancreas CancerGastroesophageal Junction Adenocarcinoma

Investigational drug(s) / intervention(s)

TORL-2-307-ADC

TORL-2-307-ADC: antibody drug conjugate

Study summary

This first-in-human study will evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of TORL-2-307-ADC 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-2-307-ADC * 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 (12)

FacilityCityRegionStatus
Providence St. Jude Medical Center Fullerton California
UCLA - JCCC Clinical Research Unit Los Angeles California
Torrance Memorial Medical Torrance California
Fort Wayne Medical Oncology and Hematology Fort Wayne Indiana
Washington University School of Medicine-Siteman Cancer Center St Louis Missouri
Texas Oncology-Austin Austin Texas
Texas Oncology-Dallas Dallas Texas
START San Antonio San Antonio Texas
Texas Oncology-Tyler Tyler Texas
Seoul National University Hospital Seoul South Korea
Severance Hospital, Yonsei University Health System Seoul South Korea
Seoul National University Bundang Hospital Seoul South Korea
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 NCT05156866 on ClinicalTrials.gov ↗ ← All trials in the USA