First in Human Study of TORL-1-23 in Participants With Advanced Cancer

Phase 1

Recruiting

• Conditions: Advanced Solid Tumor; Endometrial Cancer; NSCLC; Ovarian Cancer
• Interventions: Drug: TORL-1-23

• Registration Number: NCT05103683
• Lead Sponsor: TORL Biotherapeutics, LLC

Brief Summary

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

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations
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Related News

Study Timeline

• Study First Submitted: 2021-10-21
• Study First Submitted QC: 2021-10-21
• Study First Posted: 2021-11-02
• Study Start: 2021-11-17
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-18
• Last Update Posted: 2024-10-22
• Primary Completion: 2024-11-15
• Study Completion: 2025-11-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• Advanced solid tumor
• Measurable disease, per RECIST v1.1
• Eastern Cooperative Oncology Group (ECOG) performance status 0-1
• Adequate organ function

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Expansion as Monotherapy - Part 2	TORL-1-23	TORL-1-23
Monotherapy Dose Finding - Part 1	TORL-1-23	TORL-1-23

Primary Outcome Measures

Name	Time	Method
Recommended Phase 2 Dose (RP2D)	up to 2 years	Based on the maximum tolerated dose, cumulative safety, and pharmacokinetic data
Maximum Tolerated Dose (MTD)	28 Days	Highest administered dose with \< 33% participants experiencing dose limiting toxicity (DLT) in the first 6 DLT evaluable participants
Incidence and severity of adverse events and serious adverse events	up to 2 years	Incidence and severity of adverse events, serious adverse events, according to NCI-CTCAE Version 5.0

Secondary Outcome Measures

Name	Time	Method
Terminal Half-life (t1/2) of Serum TORL-1-23	63 days	PK Assessment
Duration of Response (DOR)	up to 2 years	Time from CR or PR to objective disease progression or death to any cause
Objective Response Rate (ORR)	up to 2 years	Percentage of participants with best response of complete response (CR) or partial response (PR) according to RECIST 1.1
1 Year Overall Survival (1YOS)	1 year	Proportion of participants alive at 1 year from the start of treatment to death from any cause
2 Year Overall Survival (2YOS)	2 years	Proportion of participants alive at 2 years from the start of treatment to death from any cause
Maximum Serum Concentration of TORL-1-23 (Cmax)	21 days	PK assessment
Time to Response (TTR)	up to 2 years	Time from start of treatment to complete response or partial response
Number of anti-drug antibody (ADA) Positive Participants	up to 2 years	Immunogenicity will be measured by the number of participants that are ADA positive.
Minimum Serum Concentration of TORL-1-23 (Cmin)	21 days	PK assessment
Apparent volume of distribution during the terminal phase (Vz) of TORL-1-23	63 days	PK Assessment
Area under the Serum Concentration-Time curve from the time of dosing to the last measurable concentration (AUClast) for TORL-1-23	21 days	PK Assessment
Area under the Serum Concentration-Time curve from the time of dosing extrapolated to time infinity (AUCinf) for TORL-1-23	63 days	PK Assessment
Maximum Serum Concentration of TORL-1-23 at Steady State (Cmax,ss)	63 days	PK assessment
Progression Free Survival (PFS)	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
Minimum Serum Concentration of TORL-1-23 at Steady State (Cmin,ss)	63 days	PK assessment
Time of Maximum Serum Concentration of TORL-1-23 (Tmax)	21 days	PK assessment
Time of Minimum Serum Concentration of TORL-1-23 (Tmin)	21 days	PK Assessment
Time of Minimum Serum Concentration of TORL-1-23 at Steady State (Tmin,ss)	63 days	PK Assessment
Clearance (CL) of TORL-1-23	63 days	PK Assessment
Accumulation ratio (Rac) of TORL-1-23	63 days	PK Assessment

Trial Locations

Locations (5)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States

Providence Medical Foundation; 🇺🇸 Fullerton, California, United States

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States

UCLA - JCCC Clinical Research Unit; 🇺🇸 Los Angeles, California, United States

Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States