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RecruitingAdvanced Solid TumorHepatocellular Carcinoma

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

Eligible age

18+ yrs

Accepts

All genders

Locations

5 states

Healthy volunteers

No

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About this study

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).

Sponsor: TORL Biotherapeutics, LLC

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-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

Where it's recruiting

Arizona

Phoenix

California

Fullerton · Los Angeles · Torrance

Florida

Jacksonville · Orlando

Minnesota

Rochester

Virginia

Lexington

Source: ClinicalTrials.gov · NCT06005740 · last updated 2025-03-04

A Phase 1, First in Human Study of TORL-4-500 in Patients With Advance · TrialPath