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

Gastric Cancer Clinical Trial

Official title:

A Phase 1, First in Human, Dose-Escalation Study of TORL-2-307-MAB in Participants With Advanced Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05159440
• Other study ID #: TORL2307MAB-001
• Status: Recruiting
• Phase: Phase 1
• Start date: January 20, 2022
• Est. completion date: December 15, 2025

Study information

• Verified date: December 2023
• Source: TORL Biotherapeutics, LLC
• Contact: Stephen Letrent, PharmD, PhD
• Phone: 858-342-6652
• Email: stephen.letrent[@]torlbio.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: December 15, 2025
• Est. primary completion date: December 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-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

Related Conditions & MeSH terms

• Advanced Solid Tumor
• Gastric Cancer
• Gastroesophageal Junction Adenocarcinoma
• Pancreas Cancer
• Pancreatic Neoplasms

Intervention

Drug:
• TORL-2-307-MAB
monoclonal antibody

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	Severance Hospital, Yonsei University Health System	Seoul
United States	Fort Wayne Medical Oncology and Hematology	Fort Wayne	Indiana
United States	Providence St. Jude Medical Center	Fullerton	California
United States	UCLA - JCCC Clinical Research Unit	Los Angeles	California
United States	Torrance Memorial Medical	Torrance	California

Sponsors (2)

Lead Sponsor	Collaborator
TORL Biotherapeutics, LLC	Translational Research in Oncology

Countries where clinical trial is conducted

United States,  Korea, Republic of, 

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-2-307-MAB (Cmax)	PK assessment	21 days
Secondary	Minimum Serum Concentration of TORL-2-307-MAB (Cmin)	PK assessment	21 days
Secondary	Maximum Serum Concentration of TORL-2-307-MAB at Steady State (Cmax,ss)	PK assessment	63 days
Secondary	Minimum Serum Concentration of TORL-2-307-MAB at Steady State (Cmin,ss)	PK assessment	63 days
Secondary	Time of Maximum Serum Concentration of TORL-2-307-MAB (Tmax)	PK assessment	21 days
Secondary	Time of Minimum Serum Concentration of TORL-2-307-MAB (Tmin)	PK Assessment	21 days
Secondary	Time of Minimum Serum Concentration of TORL-2-307-MAB at Steady State (Tmin,ss)	PK Assessment	63 days
Secondary	Terminal Half-life (t1/2) of Serum TORL-2-307-MAB	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-2-307-MAB	PK Assessment	63 days
Secondary	Clearance (CL) of TORL-2-307-MAB	PK Assessment	63 days
Secondary	Accumulation ratio (Rac) of TORL-2-307-MAB	PK Assessment	63 days