Thinking of joining a study?

Register your interest

Become a volunteer?

NCT06005740 | RECRUITING | Advanced Solid Tumor

A Phase 1, First in Human Study of TORL-4-500 in Patients With Advanced Cancer
Sponsor:

TORL Biotherapeutics, LLC

Brief Summary:

This first-in-human study will evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of TORL-4-500 in patients with advanced cancer. For Part 1, any advanced or metastatic solid tumor malignancy will be evaluated including, for example, adrenocortical carcinoma (ACC).

Condition or disease

Advanced Solid Tumor

Hepatocellular Carcinoma

Intervention/treatment

TORL-4-500

Phase

PHASE1

Study Type : INTERVENTIONAL
Estimated Enrollment : 70 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : A Phase 1, First in Human Study of TORL-4-500 in Patients With Advanced Cancer
Actual Study Start Date : 2023-12-04
Estimated Primary Completion Date : 2025-10-31
Estimated Study Completion Date : 2026-10-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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-4-500
  • * 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
A Phase 1, First in Human Study of TORL-4-500 in Patients With Advanced Cancer

Location Details

NCT06005740

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Arizona

Mayo Clinic Phoenix

Phoenix, Arizona, United States, 85054

RECRUITING

United States, California

Providence Medical Foundation

Fullerton, California, United States, 92835

RECRUITING

United States, California

UCLA - JCCC Clinical Research Unit

Los Angeles, California, United States, 90095

RECRUITING

United States, California

Torrance Memorial Physician Network

Torrance, California, United States, 90505

RECRUITING

United States, Florida

Mayo Clinic Jacksonville

Jacksonville, Florida, United States, 32224

RECRUITING

United States, Florida

Florida Cancer Specialists Lake Nona Drug Development Unit

Orlando, Florida, United States, 32827

RECRUITING

United States, Minnesota

Mayo Clinic Rochester

Rochester, Minnesota, United States, 55905

RECRUITING

United States, Virginia

Virginia Cancer Specialists

Lexington, Virginia, United States, 22031

RECRUITING

Canada, Ontario

University Health Network, Princess Margaret Cancer Centre

Toronto, Ontario, Canada, M5G 2M9

RECRUITING

Canada, Quebec

McGill University Health Centre

Montréal, Quebec, Canada, H4A 3J1