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Not recruiting
Phase 1

TORL-3-600

Sponsor:

TORL Biotherapeutics, LLC

Code:

NCT05948826

Conditions

Advanced Solid Tumor

Colorectal Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

TORL-3-600

Study Details

Brief summary:

This first-in-human study will evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of TORL-3-600 in patients with advanced cancer

Conditions

Advanced Solid Tumor

Colorectal Cancer

Study ID

NCT05948826

Start date

Sep 29, 2023

Status verified date

Oct, 2024

Completion date

Sep 15, 2026

Anticipated

Primary completion date

Sep 15, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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-3-600
  • 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

Enrollment

70 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Monotherapy Dose Dose Finding - Part 1

TORL-3-600

experimental: Expansion as Monotherapy - Part 2

TORL-3-600

Interventions

TORL-3-600

antibody drug conjugate

Primary outcome measure

  • Incidence and severity of adverse events and serious adverse events [ Time Frame: up to 2 years ]
  • Maximum Tolerated Dose (MTD) [ Time Frame: 28 Days ]
  • Recommended Phase 2 Dose (RP2D) [ Time Frame: up to 2 years ]

Central Contacts and Locations

Central contacts

Brandon Sookdeo

909-333-8966brandon.sookdeo@torlbio.com

Locations

Providence Medical Foundation

Recruiting

Fullerton, California, United States, 92835

Principal Investigator:

Yung Lyou, MD

UCLA - JCCC Clinical Research Unit

Recruiting

Los Angeles, California, United States, 90095

Contacts

Zev Wainberg, MD

310-586-2094

Sarah Cannon Research Institute

Recruiting

Denver, Colorado, United States, 80218

Principal Investigator:

Jason Henry, MD

Fort Wayne Medical Oncology and Hematology Inc.

Recruiting

Fort Wayne, Indiana, United States, 46845

Principal Investigator:

Sunil Babu, MD

Washington University School of Medicine-Siteman Cancer Center

Recruiting

Saint Louis, Missouri, United States, 63110

Mary Crowley Cancer Research

Recruiting

Dallas, Texas, United States, 75230

University Health Network, Princess Margaret Cancer Centre

Recruiting

Toronto, Ontario, Canada, M5G 2M9

Principal Investigator:

Abdulazeez Salawu

McGill University Health Centre

Recruiting

Montréal, Quebec, Canada, H4A 3J1

More Information

Sponsor

TORL Biotherapeutics, LLC

Last update posted

Oct 22, 2024

Last verified

Oct, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-15. This information was provided to ClinicalTrials.gov by TORL Biotherapeutics, LLC on 2024-10-22.