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Recruiting NCT05103683

First in Human Study of TORL-1-23 in Participants With Advanced Cancer

Phase I Interventional Advanced Solid Tumor Ovarian Cancer Endometrial Cancer NSCLC

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-1-23.
Who it may be relevant to
Registry conditions: Advanced Solid Tumor, Ovarian Cancer, Endometrial Cancer, NSCLC. 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, South Korea
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 →

Official title

A Phase 1, First in Human, Dose-Escalation Study of TORL-1-23 in Participants With Advanced Cancer

Overview

This first-in-human study will evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of TORL-1-23 in patients with advanced cancer

Interventions

  • Drug TORL-1-23
    antibody drug conjugate (ADC)

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-1-23 (Cmax) [Time frame: 21 days]
  • Minimum Serum Concentration of TORL-1-23 (Cmin) [Time frame: 21 days]
  • Maximum Serum Concentration of TORL-1-23 at Steady State (Cmax,ss) [Time frame: 63 days]
  • Minimum Serum Concentration of TORL-1-23 at Steady State (Cmin,ss) [Time frame: 63 days]
  • Time of Maximum Serum Concentration of TORL-1-23 (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-1-23
  • 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 · 9 centers
  • Providence Medical Foundation — Fullerton
  • UCLA - JCCC Clinical Research Unit — Los Angeles
  • University of Kentucky Medical Center — Lexington
  • University of Minnesota — Minneapolis
  • Mayo Clinic in Rochester — Rochester
  • Memorial Sloan Kettering Cancer Center — New York
  • Cleveland Clinic — Cleveland
  • Sarah Cannon Research Institute Texas Oncology — Tyler
  • … and 1 more center
South Korea · 5 centers
  • St. Vincent's Hospital, The Catholic University of Korea — Suwon
  • Seoul National University Hospital — Seoul
  • Severance Hospital — Seoul
  • Asan Medical Center — Seoul
  • Samsung Medical Center — Seoul

Identifiers

NCT: NCT05103683 · TORL123-001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗