Actively Recruiting

Phase 1
Age: 18Years +
All Genders
NCT06005740

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

Led by TORL Biotherapeutics, LLC · Updated on 2025-03-04

70

Participants Needed

10

Research Sites

151 weeks

Total Duration

On this page

Sponsors

T

TORL Biotherapeutics, LLC

Lead Sponsor

T

Translational Research in Oncology

Collaborating Sponsor

AI-Summary

What this Trial Is About

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).

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Advanced solid tumor
  • Measurable disease according to RECIST v1.1
  • ECOG performance status of 0 or 1
  • Adequate organ function
Not Eligible

You will not qualify if you...

  • Not recovered from acute toxicities of previous therapy except treatment-related hair loss or eligible lab abnormalities
  • Received chemotherapeutic, investigational, or other cancer therapies within 14 days for small molecules or 28 days for biologics before first dose
  • 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 or acute myeloid leukemia
  • History of another cancer within 3 years before study treatment except definitively treated basal or squamous cell skin cancer
  • Pregnant or breastfeeding if female

AI-Screening

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Trial Site Locations

Total: 10 locations

1

Mayo Clinic Phoenix

Phoenix, Arizona, United States, 85054

Actively Recruiting

2

Providence Medical Foundation

Fullerton, California, United States, 92835

Actively Recruiting

3

UCLA - JCCC Clinical Research Unit

Los Angeles, California, United States, 90095

Actively Recruiting

4

Torrance Memorial Physician Network

Torrance, California, United States, 90505

Actively Recruiting

5

Mayo Clinic Jacksonville

Jacksonville, Florida, United States, 32224

Actively Recruiting

6

Florida Cancer Specialists Lake Nona Drug Development Unit

Orlando, Florida, United States, 32827

Actively Recruiting

7

Mayo Clinic Rochester

Rochester, Minnesota, United States, 55905

Actively Recruiting

8

Virginia Cancer Specialists

Lexington, Virginia, United States, 22031

Actively Recruiting

9

University Health Network, Princess Margaret Cancer Centre

Toronto, Ontario, Canada, M5G 2M9

Actively Recruiting

10

McGill University Health Centre

Montreal, Quebec, Canada, H4A 3J1

Actively Recruiting

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Research Team

C

Caroline Labib, PharmD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

2

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