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

Phase 1

Active, not recruiting

• Conditions: Gastric Cancer; Advanced Solid Tumor; Pancreas Cancer; Gastroesophageal Junction Adenocarcinoma
• Interventions: Drug: TORL-2-307-MAB

• Registration Number: NCT05159440
• Lead Sponsor: TORL Biotherapeutics, LLC

Brief Summary

This first-in-human study will evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of TORL-2-307-MAB 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: 2021-12-01
• Study First Submitted QC: 2021-12-01
• Study First Posted: 2021-12-16
• Study Start: 2022-01-20
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-18
• Last Update Posted: 2024-10-22
• Primary Completion: 2024-12-15
• Study Completion: 2025-12-15

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 70

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-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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Expansion as Monotherapy - Part 2	TORL-2-307-MAB	TORL-2-307-MAB
Monotherapy Dose Dose Finding - Part 1	TORL-2-307-MAB	TORL-2-307-MAB

Primary Outcome Measures

Name	Time	Method
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
Recommended Phase 2 Dose (RP2D)	up to 2 years	Based on the maximum tolerated dose, cumulative safety, and pharmacokinetic data

Secondary Outcome Measures

Name	Time	Method
Accumulation ratio (Rac) of TORL-2-307-MAB	63 days	PK Assessment
Area under the Serum Concentration-Time curve from the time of dosing to the last measurable concentration (AUClast) for TORL-2-307-MAB	21 days	PK Assessment
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
Duration of Response (DOR)	up to 2 years	Time from CR or PR to objective disease progression or death to any cause
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
Time to Response (TTR)	up to 2 years	Time from start of treatment to complete response or partial response
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
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.
Maximum Serum Concentration of TORL-2-307-MAB (Cmax)	21 days	PK assessment
Minimum Serum Concentration of TORL-2-307-MAB (Cmin)	21 days	PK assessment
Maximum Serum Concentration of TORL-2-307-MAB at Steady State (Cmax,ss)	63 days	PK assessment
Minimum Serum Concentration of TORL-2-307-MAB at Steady State (Cmin,ss)	63 days	PK assessment
Time of Maximum Serum Concentration of TORL-2-307-MAB (Tmax)	21 days	PK assessment
Time of Minimum Serum Concentration of TORL-2-307-MAB (Tmin)	21 days	PK Assessment
Time of Minimum Serum Concentration of TORL-2-307-MAB at Steady State (Tmin,ss)	63 days	PK Assessment
Terminal Half-life (t1/2) of Serum TORL-2-307-MAB	63 days	PK Assessment
Area under the Serum Concentration-Time curve from the time of dosing extrapolated to time infinity (AUCinf) for TORL-2-307-MAB	63 days	PK Assessment
Apparent volume of distribution during the terminal phase (Vz) of TORL-2-307-MAB	63 days	PK Assessment
Clearance (CL) of TORL-2-307-MAB	63 days	PK Assessment

Trial Locations

Locations (8)

Providence St. Jude Medical Center; 🇺🇸 Fullerton, California, United States

Torrance Memorial Medical; 🇺🇸 Torrance, California, United States

Fort Wayne Medical Oncology and Hematology; 🇺🇸 Fort Wayne, Indiana, United States

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of

Seoul National University Bundang Hospital; 🇰🇷 Seoul, Korea, Republic of

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

Washington University School of Medicine-Siteman Cancer Center; 🇺🇸 Saint Louis, Missouri, United States

Severance Hospital, Yonsei University Health System; 🇰🇷 Seoul, Korea, Republic of