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

Phase 1Active Not RecruitingNCT06005740

TORL Biotherapeutics, LLC70 enrolled

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).

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Advanced Solid Tumor Hepatocellular Carcinoma

Interventions

TORL-4-500DRUG

antibody drug conjugate

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (10)

Mayo Clinic Phoenix

Phoenix, Arizona, United States

Providence Medical Foundation

Fullerton, California, United States

UCLA - JCCC Clinical Research Unit

Los Angeles, California, United States

Outcomes

Primary Outcomes

Incidence and severity of adverse events and serious adverse events

Incidence and severity of adverse events, serious adverse events, according to NCI-CTCAE Version 5.0

Time frame: up to 2 years

Maximum Tolerated Dose (MTD)

Highest administered dose with \< 33% participants experiencing dose limiting toxicity (DLT) in the first 6 DLT evaluable participants

Time frame: 28 Days

Recommended Phase 2 Dose (RP2D)

Based on the maximum tolerated dose, cumulative safety, and pharmacokinetic data

Time frame: up to 2 years

Secondary Outcomes

Objective Response Rate (ORR)

Percentage of participants with best response of complete response (CR) or partial response (PR) according to RECIST 1.1

Time frame: up to 2 years

Duration of Response (DOR)

Time from CR or PR to objective disease progression or death to any cause

Time frame: up to 2 years

Progression Free Survival (PFS)

PFS is defined as the time from the start of the treatment until objective disease progression or death from any cause

Time frame: up to 2 years

Time to Response (TTR)

Time from start of treatment to complete response or partial response

Time frame: up to 2 years

1 Year Overall Survival (1YOS)

Data from ClinicalTrials.gov

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