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Recruiting NCT06005740

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

Phase I Interventional Advanced Solid Tumor Hepatocellular Carcinoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: TORL-4-500.
Who it may be relevant to
Registry conditions: Advanced Solid Tumor, Hepatocellular Carcinoma. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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).

Interventions

  • Drug TORL-4-500
    antibody drug conjugate

Primary outcome measures

  • 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]
Secondary outcome measures (12)
  • Objective Response Rate (ORR) [Time frame: up to 2 years]
  • Duration of Response (DOR) [Time frame: up to 2 years]
  • Progression Free Survival (PFS) [Time frame: up to 2 years]
  • Time to Response (TTR) [Time frame: up to 2 years]
  • 1 Year Overall Survival (1YOS) [Time frame: 1 year]
  • 2 Year Overall Survival (2YOS) [Time frame: 2 years]
  • Number of anti-drug antibody (ADA) Positive Participants [Time frame: up to 2 years]
  • Maximum Serum Concentration of TORL-4-500 (Cmax) [Time frame: 21 days]
  • Minimum Serum Concentration of TORL-4-500 (Cmin) [Time frame: 21 days]
  • Maximum Serum Concentration of TORL-4-500 at Steady State (Cmax,ss) [Time frame: 63 days]
  • Minimum Serum Concentration of TORL-4-500 at Steady State (Cmin,ss) [Time frame: 63 days]
  • Time of Maximum Serum Concentration of TORL-4-500 (Tmax) [Time frame: 21 days]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Sequential
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 8 centers
  • Mayo Clinic Phoenix — Phoenix
  • Providence Medical Foundation — Fullerton
  • UCLA - JCCC Clinical Research Unit — Los Angeles
  • Torrance Memorial Physician Network — Torrance
  • Mayo Clinic Jacksonville — Jacksonville
  • Florida Cancer Specialists Lake Nona Drug Development Unit — Orlando
  • Mayo Clinic Rochester — Rochester
  • Virginia Cancer Specialists — Lexington
Canada · 2 centers
  • University Health Network, Princess Margaret Cancer Centre — Toronto
  • McGill University Health Centre — Montreal

Identifiers

NCT: NCT06005740 · TORL4500-001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗