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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05103683
Other study ID # TORL123-001
Secondary ID
Status Recruiting
Phase Phase 1
First received
Last updated
Start date November 17, 2021
Est. completion date November 15, 2025

Study information

Verified date April 2024
Source TORL Biotherapeutics, LLC
Contact Stephen Letrent, PharmD, PhD
Phone 858-342-6652
Email stephen.letrent@torlbio.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This first-in-human study will evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of TORL-1-23 in patients with advanced cancer


Recruitment information / eligibility

Status Recruiting
Enrollment 90
Est. completion date November 15, 2025
Est. primary completion date November 15, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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-1-23 - 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 Design


Intervention

Drug:
TORL-1-23
antibody drug conjugate (ADC)

Locations

Country Name City State
United States Cleveland Clinic Cleveland Ohio
United States UCLA - JCCC Clinical Research Unit Los Angeles California
United States University of Minnesota Minneapolis Minnesota
United States Mayo Clinic in Rochester Rochester Minnesota

Sponsors (2)

Lead Sponsor Collaborator
TORL Biotherapeutics, LLC Translational Research in Oncology

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary Maximum Tolerated Dose (MTD) Highest administered dose with < 33% participants experiencing dose limiting toxicity (DLT) in the first 6 DLT evaluable participants 28 Days
Primary Recommended Phase 2 Dose (RP2D) Based on the maximum tolerated dose, cumulative safety, and pharmacokinetic data up to 2 years
Secondary Objective Response Rate (ORR) Percentage of participants with best response of complete response (CR) or partial response (PR) according to RECIST 1.1 up to 2 years
Secondary Duration of Response (DOR) Time from CR or PR to objective disease progression or death to any cause up to 2 years
Secondary Progression Free Survival (PFS) 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
Secondary Time to Response (TTR) Time from start of treatment to complete response or partial response up to 2 years
Secondary 1 Year Overall Survival (1YOS) Proportion of participants alive at 1 year from the start of treatment to death from any cause 1 year
Secondary 2 Year Overall Survival (2YOS) Proportion of participants alive at 2 years from the start of treatment to death from any cause 2 years
Secondary Number of anti-drug antibody (ADA) Positive Participants Immunogenicity will be measured by the number of participants that are ADA positive. up to 2 years
Secondary Maximum Serum Concentration of TORL-1-23 (Cmax) PK assessment 21 days
Secondary Minimum Serum Concentration of TORL-1-23 (Cmin) PK assessment 21 days
Secondary Maximum Serum Concentration of TORL-1-23 at Steady State (Cmax,ss) PK assessment 63 days
Secondary Minimum Serum Concentration of TORL-1-23 at Steady State (Cmin,ss) PK assessment 63 days
Secondary Time of Maximum Serum Concentration of TORL-1-23 (Tmax) PK assessment 21 days
Secondary Time of Minimum Serum Concentration of TORL-1-23 (Tmin) PK Assessment 21 days
Secondary Time of Minimum Serum Concentration of TORL-1-23 at Steady State (Tmin,ss) PK Assessment 63 days
Secondary Terminal Half-life (t1/2) of Serum TORL-1-23 PK Assessment 63 days
Secondary Area under the Serum Concentration-Time curve from the time of dosing to the last measurable concentration (AUClast) for TORL-1-23 PK Assessment 21 days
Secondary Area under the Serum Concentration-Time curve from the time of dosing extrapolated to time infinity (AUCinf) for TORL-1-23 PK Assessment 63 days
Secondary Apparent volume of distribution during the terminal phase (Vz) of TORL-1-23 PK Assessment 63 days
Secondary Clearance (CL) of TORL-1-23 PK Assessment 63 days
Secondary Accumulation ratio (Rac) of TORL-1-23 PK Assessment 63 days
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