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
1 other identifier
interventional
163
2 countries
12
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Feb 2022
Longer than P75 for phase_1
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 1, 2021
CompletedFirst Posted
Study publicly available on registry
December 14, 2021
CompletedStudy Start
First participant enrolled
February 2, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 15, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 15, 2027
January 13, 2026
January 1, 2026
4.4 years
December 1, 2021
January 9, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Incidence and severity of adverse events and serious adverse events
Incidence and severity of adverse events, serious adverse events, according to NCI-CTCAE Version 5.0
up to 2 years
Maximum Tolerated Dose (MTD)
Highest administered dose with \< 33% participants experiencing dose limiting toxicity (DLT) in the first 6 DLT evaluable participants
28 Days
Recommended Phase 2 Dose (RP2D)
Based on the maximum tolerated dose, cumulative safety, and pharmacokinetic data
up to 2 years
Secondary Outcomes (20)
Objective Response Rate (ORR)
up to 2 years
Duration of Response (DOR)
up to 2 years
Progression Free Survival (PFS)
up to 2 years
Time to Response (TTR)
up to 2 years
1 Year Overall Survival (1YOS)
1 year
- +15 more secondary outcomes
Study Arms (2)
Monotherapy Dose Dose Finding - Part 1
EXPERIMENTALTORL-2-307-ADC
Expansion as Monotherapy - Part 2
EXPERIMENTALTORL-2-307-ADC
Interventions
antibody drug conjugate
Eligibility Criteria
You may qualify if:
- Advanced solid tumor
- Measurable disease, per RECIST v1.1
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Adequate organ function
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- TORL Biotherapeutics, LLClead
- Translational Research in Oncologycollaborator
Study Sites (12)
Providence St. Jude Medical Center
Fullerton, California, 92835, United States
UCLA - JCCC Clinical Research Unit
Los Angeles, California, 90095, United States
Torrance Memorial Medical
Torrance, California, 90505, United States
Fort Wayne Medical Oncology and Hematology
Fort Wayne, Indiana, 46804, United States
Washington University School of Medicine-Siteman Cancer Center
St Louis, Missouri, 63310, United States
Texas Oncology-Austin
Austin, Texas, 78705, United States
Texas Oncology-Dallas
Dallas, Texas, 75246, United States
START San Antonio
San Antonio, Texas, 78229, United States
Texas Oncology-Tyler
Tyler, Texas, 75702, United States
Seoul National University Hospital
Seoul, 03080, South Korea
Severance Hospital, Yonsei University Health System
Seoul, 03722, South Korea
Seoul National University Bundang Hospital
Seoul, 13620, South Korea
Related Publications (1)
O'Brien NA, McDermott MSJ, Zhang J, Gong KW, Lu M, Hoffstrom B, Luo T, Ayala R, Chau K, Liang M, Madrid AM, Donahue TR, Glaspy JA, Presta L, Slamon DJ. Development of a Novel CLDN18.2-directed Monoclonal Antibody and Antibody-Drug Conjugate for Treatment of CLDN18.2-Positive Cancers. Mol Cancer Ther. 2023 Dec 1;22(12):1365-1375. doi: 10.1158/1535-7163.MCT-23-0353.
PMID: 37788341DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Ibrahim Qazi, PharmD
TORL Biotherapeutics, LLC
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 1, 2021
First Posted
December 14, 2021
Study Start
February 2, 2022
Primary Completion (Estimated)
June 15, 2026
Study Completion (Estimated)
February 15, 2027
Last Updated
January 13, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will not share