- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05156866
First in Human Study of TORL-2-307-ADC in Participants With Advanced Cancer
December 8, 2023 updated by: TORL Biotherapeutics, LLC
A Phase 1, First in Human, Dose-Escalation Study of TORL-2-307-ADC in Participants With Advanced Cancer
This first-in-human study will evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of TORL-2-307-ADC in patients with advanced cancer
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
70
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Stephen Letrent, PharmD, PhD
- Phone Number: 858-342-6652
- Email: stephen.letrent@torlbio.com
Study Locations
-
-
-
Seoul, Korea, Republic of, 03080
- Recruiting
- Seoul National University Hospital
-
Contact:
- Tae Yong Kim
-
Seoul, Korea, Republic of, 03722
- Recruiting
- Severance Hospital, Yonsei University Health System
-
Contact:
- Sun Young Rha
-
Seoul, Korea, Republic of, 13620
- Recruiting
- Seoul National University Bundang Hospital
-
Contact:
- Keun Wook Lee
-
-
-
-
California
-
Fullerton, California, United States, 92835
- Recruiting
- Providence St. Jude Medical Center
-
Contact:
- David J Park, MD
-
Los Angeles, California, United States, 90095
- Recruiting
- UCLA - JCCC Clinical Research Unit
-
Contact:
- Zev Wainberg, MD
- Phone Number: 310-586-2094
-
Torrance, California, United States, 90505
- Recruiting
- Torrance Memorial Medical
-
Contact:
- Hugo Hool, MD
-
-
Indiana
-
Fort Wayne, Indiana, United States, 46804
- Recruiting
- Fort Wayne Medical Oncology and Hematology
-
Contact:
- Sunil Babu, MD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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-MAB
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Monotherapy Dose Dose Finding - Part 1
TORL-2-307-ADC
|
antibody drug conjugate
|
Experimental: Expansion as Monotherapy - Part 2
TORL-2-307-ADC
|
antibody drug conjugate
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence and severity of adverse events and serious adverse events
Time Frame: up to 2 years
|
Incidence and severity of adverse events, serious adverse events, according to NCI-CTCAE Version 5.0
|
up to 2 years
|
Maximum Tolerated Dose (MTD)
Time Frame: 28 Days
|
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)
Time Frame: up to 2 years
|
Based on the maximum tolerated dose, cumulative safety, and pharmacokinetic data
|
up to 2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Objective Response Rate (ORR)
Time Frame: up to 2 years
|
Percentage of participants with best response of complete response (CR) or partial response (PR) according to RECIST 1.1
|
up to 2 years
|
Duration of Response (DOR)
Time Frame: up to 2 years
|
Time from CR or PR to objective disease progression or death to any cause
|
up to 2 years
|
Progression Free Survival (PFS)
Time Frame: up to 2 years
|
PFS is defined as the time from the start of the treatment until objective disease progression or death from any cause
|
up to 2 years
|
Time to Response (TTR)
Time Frame: up to 2 years
|
Time from start of treatment to complete response or partial response
|
up to 2 years
|
1 Year Overall Survival (1YOS)
Time Frame: 1 year
|
Proportion of participants alive at 1 year from the start of treatment to death from any cause
|
1 year
|
2 Year Overall Survival (2YOS)
Time Frame: 2 years
|
Proportion of participants alive at 2 years from the start of treatment to death from any cause
|
2 years
|
Number of anti-drug antibody (ADA) Positive Participants
Time Frame: up to 2 years
|
Immunogenicity will be measured by the number of participants that are ADA positive.
|
up to 2 years
|
Area under the Serum Concentration-Time curve from the time of dosing to the last measurable concentration (AUClast) for TORL-1-23
Time Frame: 21 days
|
PK Assessment
|
21 days
|
Area under the Serum Concentration-Time curve from the time of dosing extrapolated to time infinity (AUCinf) for TORL-1-23
Time Frame: 63 days
|
PK Assessment
|
63 days
|
Maximum Serum Concentration of TORL-2-307-ADC (Cmax)
Time Frame: 21 days
|
PK assessment
|
21 days
|
Minimum Serum Concentration of TORL-2-307-ADC (Cmin)
Time Frame: 21 days
|
PK assessment
|
21 days
|
Maximum Serum Concentration of TORL-2-307-ADC at Steady State (Cmax,ss)
Time Frame: 63 days
|
PK assessment
|
63 days
|
Minimum Serum Concentration of TORL-2-307-ADC at Steady State (Cmin,ss)
Time Frame: 63 days
|
PK assessment
|
63 days
|
Time of Maximum Serum Concentration of TORL-2-307-ADC (Tmax)
Time Frame: 21 days
|
PK assessment
|
21 days
|
Time of Minimum Serum Concentration of TORL-2-307-ADC (Tmin)
Time Frame: 21 days
|
PK Assessment
|
21 days
|
Time of Minimum Serum Concentration of TORL-2-307-ADC at Steady State (Tmin,ss)
Time Frame: 63 days
|
PK Assessment
|
63 days
|
Terminal Half-life (t1/2) of Serum TORL-2-307-ADC
Time Frame: 63 days
|
PK Assessment
|
63 days
|
Apparent volume of distribution during the terminal phase (Vz) of TORL-2-307-ADC
Time Frame: 63 days
|
PK Assessment
|
63 days
|
Clearance (CL) of TORL-2-307-ADC
Time Frame: 63 days
|
PK Assessment
|
63 days
|
Accumulation ratio (Rac) of TORL-2-307-ADC
Time Frame: 63 days
|
PK Assessment
|
63 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Director: Stephen Letrent, PharmD, PhD, TORL Biotherapeutics, LLC
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 2, 2022
Primary Completion (Estimated)
January 15, 2025
Study Completion (Estimated)
January 15, 2026
Study Registration Dates
First Submitted
December 1, 2021
First Submitted That Met QC Criteria
December 1, 2021
First Posted (Actual)
December 14, 2021
Study Record Updates
Last Update Posted (Estimated)
December 12, 2023
Last Update Submitted That Met QC Criteria
December 8, 2023
Last Verified
December 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- TORL2307ADC-001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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