Clinical trial NCT06005740: A Phase 1, First in Human Study of TORL-4-500 in Patients With Advanced Cancer
Official title: A Phase 1, First in Human Study of TORL-4-500 in Patients With Advanced Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Advanced Solid Tumor
Hepatocellular Carcinoma
Keywords: ADC
Lead sponsor: TORL Biotherapeutics, LLC
Sponsor class: INDUSTRY
Collaborators: name: Translational Research in Oncology
First posted: 2023-08-22
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief 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).


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

Primary outcomes:
measure: Incidence and severity of adverse events and serious adverse events
timeFrame: up to 2 years
measure: Maximum Tolerated Dose (MTD)
timeFrame: 28 Days
measure: Recommended Phase 2 Dose (RP2D)
timeFrame: up to 2 years
Secondary outcomes:
measure: Objective Response Rate (ORR)
timeFrame: up to 2 years
measure: Duration of Response (DOR)
timeFrame: up to 2 years
measure: Progression Free Survival (PFS)
timeFrame: up to 2 years
measure: Time to Response (TTR)
timeFrame: up to 2 years
measure: 1 Year Overall Survival (1YOS)
timeFrame: 1 year
measure: 2 Year Overall Survival (2YOS)
timeFrame: 2 years
measure: Number of anti-drug antibody (ADA) Positive Participants
timeFrame: up to 2 years
measure: Maximum Serum Concentration of TORL-4-500 (Cmax)
timeFrame: 21 days
measure: Minimum Serum Concentration of TORL-4-500 (Cmin)
timeFrame: 21 days
measure: Maximum Serum Concentration of TORL-4-500 at Steady State (Cmax,ss)
timeFrame: 63 days
measure: Minimum Serum Concentration of TORL-4-500 at Steady State (Cmin,ss)
timeFrame: 63 days
measure: Time of Maximum Serum Concentration of TORL-4-500 (Tmax)
timeFrame: 21 days
measure: Time of Minimum Serum Concentration of TORL-4-500 (Tmin)
timeFrame: 21 days
measure: Time of Minimum Serum Concentration of TORL-4-500 at Steady State (Tmin,ss)
timeFrame: 63 days
measure: Terminal Half-life (t1/2) of Serum TORL-4-500-ADC
timeFrame: 63 days
measure: Area under the Serum Concentration-Time curve from the time of dosing to the last measurable concentration (AUClast) for TORL-4-500
timeFrame: 21 days
measure: Area under the Serum Concentration-Time curve from the time of dosing extrapolated to time infinity (AUCinf) for TORL-4-500
timeFrame: 63 days
measure: Apparent volume of distribution during the terminal phase (Vz) of TORL-4-500
timeFrame: 63 days
measure: Clearance (CL) of TORL-4-500
timeFrame: 63 days
measure: Accumulation ratio (Rac) of TORL-4-500
timeFrame: 63 days
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Mayo Clinic Phoenix
state: Arizona
city: Fullerton
country: United States
facility: Providence Medical Foundation
state: California
city: Los Angeles
country: United States
facility: UCLA - JCCC Clinical Research Unit
state: California
city: Torrance
country: United States
facility: Torrance Memorial Physician Network
state: California
city: Jacksonville
country: United States
facility: Mayo Clinic Jacksonville
state: Florida
city: Orlando
country: United States
facility: Florida Cancer Specialists Lake Nona Drug Development Unit
state: Florida
city: Rochester
country: United States
facility: Mayo Clinic Rochester
state: Minnesota
city: Lexington
country: United States
facility: Virginia Cancer Specialists
state: Virginia
city: Toronto
country: Canada
facility: University Health Network, Princess Margaret Cancer Centre
state: Ontario
city: Montréal
country: Canada
facility: McGill University Health Centre
state: Quebec
Study officials:
affiliation: TORL Biotherapeutics, LLC
name: Caroline Labib, PharmD
role: STUDY_CHAIR
References: