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

NCT05159440 | Active Not Recruiting Phase 1 FDA Drug

• 1 other identifier: TORL2307MAB-001
• Study Type: interventional
• Target: 70
• Locations: 2 countries
• Sites: 8

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

Conditions

Advanced Solid Tumor; Gastric Cancer; Pancreas Cancer; Gastroesophageal Junction Adenocarcinoma

Keywords

claudin18.2

Outcome Measures

Primary Outcomes (3)

• 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

• Maximum Tolerated Dose (MTD)

  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)

  Based on the maximum tolerated dose, cumulative safety, and pharmacokinetic data

  up to 2 years

Secondary Outcomes (20)

• Objective Response Rate (ORR)

  up to 2 years

• Duration of Response (DOR)

  up to 2 years

• Progression Free Survival (PFS)

  up to 2 years

• Time to Response (TTR)

  up to 2 years

• 1 Year Overall Survival (1YOS)

  1 year

Study Arms (2)

Monotherapy Dose Dose Finding - Part 1

EXPERIMENTAL

TORL-2-307-MAB

Drug: TORL-2-307-MAB

Expansion as Monotherapy - Part 2

EXPERIMENTAL

TORL-2-307-MAB

Drug: TORL-2-307-MAB

Interventions

TORL-2-307-MAB DRUG

monoclonal antibody

Expansion as Monotherapy - Part 2; Monotherapy Dose Dose Finding - Part 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• TORL Biotherapeutics, LLC: lead
• Translational Research in Oncology: collaborator

Study Sites (8)

Providence St. Jude Medical Center

Fullerton, California, 92835, United States

Location

UCLA - JCCC Clinical Research Unit

Los Angeles, California, 90095, United States

Location

Torrance Memorial Medical

Torrance, California, 90505, United States

Location

Fort Wayne Medical Oncology and Hematology

Fort Wayne, Indiana, 46804, United States

Location

Washington University School of Medicine-Siteman Cancer Center

St Louis, Missouri, 63110, United States

Location

Seoul National University Hospital

Seoul, 03080, South Korea

Location

Severance Hospital, Yonsei University Health System

Seoul, 03722, South Korea

Location

Seoul National University Bundang Hospital

Seoul, 13620, South Korea

Location

Related Publications (1)

• O'Brien NA, McDermott MSJ, Zhang J, Gong KW, Lu M, Hoffstrom B, Luo T, Ayala R, Chau K, Liang M, Madrid AM, Donahue TR, Glaspy JA, Presta L, Slamon DJ. Development of a Novel CLDN18.2-directed Monoclonal Antibody and Antibody-Drug Conjugate for Treatment of CLDN18.2-Positive Cancers. Mol Cancer Ther. 2023 Dec 1;22(12):1365-1375. doi: 10.1158/1535-7163.MCT-23-0353.

  PMID: 37788341 DERIVED

MeSH Terms

Conditions

Stomach Neoplasms; Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• Stephen Letrent, PharmD, PhD

  TORL Biotherapeutics, LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2021
• First Posted: December 16, 2021
• Study Start: January 20, 2022
• Primary Completion: December 15, 2024
• Study Completion: December 15, 2025
• Last Updated: October 22, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (5); KR (3)