RecruitingInterventionalPhase 1

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

NCT ID: NCT06005740Sponsor: TORL Biotherapeutics, LLCLast updated: 2025-03-04

Summary

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).

Arms & interventions

DrugTORL-4-500
antibody drug conjugate

Outcome measures

Primary

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

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
Time of Minimum Serum Concentration of TORL-4-500 (Tmin)
Time frame: 21 days
Time of Minimum Serum Concentration of TORL-4-500 at Steady State (Tmin,ss)
Time frame: 63 days
Terminal Half-life (t1/2) of Serum TORL-4-500-ADC
Time frame: 63 days
Area under the Serum Concentration-Time curve from the time of dosing to the last measurable concentration (AUClast) for TORL-4-500
Time frame: 21 days
Area under the Serum Concentration-Time curve from the time of dosing extrapolated to time infinity (AUCinf) for TORL-4-500
Time frame: 63 days
Apparent volume of distribution during the terminal phase (Vz) of TORL-4-500
Time frame: 63 days
Clearance (CL) of TORL-4-500
Time frame: 63 days
Accumulation ratio (Rac) of TORL-4-500
Time frame: 63 days

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No

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

Study locations (8)

Mayo Clinic Phoenix

Phoenix, Arizona, 85054

Recruiting

Mohamad Sonbol, MD · Contact

Mohamad Sonbol, MD · Principal Investigator

Providence Medical Foundation

Fullerton, California, 92835

Recruiting

Yung Lyou, MD · Contact

UCLA - JCCC Clinical Research Unit

Los Angeles, California, 90095

Recruiting

Lee Rosen, MD · Contact

310-829-5471

Torrance Memorial Physician Network

Torrance, California, 90505

Recruiting

Justin Tiulim, MD · Contact

Justin Tiulim, MD · Principal Investigator

Mayo Clinic Jacksonville

Jacksonville, Florida, 32224

Recruiting

Yanyan Lou, MD · Contact

Yanyan Lou, MD · Principal Investigator

Florida Cancer Specialists Lake Nona Drug Development Unit

Orlando, Florida, 32827

Recruiting

Cesar Perez, MD · Contact

Cesar Perez, MD · Principal Investigator

Mayo Clinic Rochester

Rochester, Minnesota, 55905

Recruiting

Andrea Wahner-Hendrickson, MD · Contact

Andrea Wahner-Hendrickson, MD · Principal Investigator

Virginia Cancer Specialists

Lexington, Virginia, 22031

Recruiting

Alexander Spira, MD · Contact