A Phase 1, First in Human, Dose-Escalation Study of TORL-3-600 in Participants With Advanced Cancer

TORL Biotherapeutics, LLC9 sites in 2 countries70 target enrollmentSeptember 29, 2023

ConditionsAdvanced Solid Tumor Colorectal Cancer

InterventionsTORL-3-600

Overview

Phase: Phase 1
Intervention: TORL-3-600
Conditions: Advanced Solid Tumor
Sponsor: TORL Biotherapeutics, LLC
Enrollment: 70
Locations: 9
Primary Endpoint: Incidence and severity of adverse events and serious adverse events
Status: Active, not recruiting
Last Updated: 6 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials Related News

Overview

Brief Summary

This first-in-human study will evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of TORL-3-600 in patients with advanced cancer

Registry

clinicaltrials.gov

Start Date

September 29, 2023

End Date

September 15, 2026

Last Updated

6 months ago

Study Type

Interventional

Study Design

Sequential

Sex

All

Investigators

Sponsor

TORL Biotherapeutics, LLC

Responsible Party

Sponsor

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-3-600
•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

Arms & Interventions

Monotherapy Dose Dose Finding - Part 1

TORL-3-600

Intervention: TORL-3-600

Expansion as Monotherapy - Part 2

TORL-3-600

Intervention: TORL-3-600

Outcomes

Primary Outcomes

Incidence and severity of adverse events and serious adverse events

Time Frame: up to 2 years

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

Maximum Tolerated Dose (MTD)

Time Frame: 28 Days

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

Recommended Phase 2 Dose (RP2D)

Time Frame: up to 2 years

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

Secondary Outcomes

Time of Maximum Serum Concentration of TORL-3-600 (Tmax)(21 days)
Time of Minimum Serum Concentration of TORL-3-600 (Tmin)(21 days)
Objective Response Rate (ORR)(up to 2 years)
Duration of Response (DOR)(up to 2 years)
Progression Free Survival (PFS)(up to 2 years)
Time to Response (TTR)(up to 2 years)
1 Year Overall Survival (1YOS)(1 year)
2 Year Overall Survival (2YOS)(2 years)
Number of anti-drug antibody (ADA) Positive Participants(up to 2 years)
Maximum Serum Concentration of TORL-3-600 (Cmax)(21 days)
Minimum Serum Concentration of TORL-3-600 (Cmin)(21 days)
Maximum Serum Concentration of TORL-3-600 at Steady State (Cmax,ss)(63 days)
Minimum Serum Concentration of TORL-3-600 at Steady State (Cmin,ss)(63 days)
Time of Minimum Serum Concentration of TORL-3-600 at Steady State (Tmin,ss)(63 days)
Terminal Half-life (t1/2) of Serum TORL-3-600-ADC(63 days)
Area under the Serum Concentration-Time curve from the time of dosing to the last measurable concentration (AUClast) for TORL-3-600(21 days)
Area under the Serum Concentration-Time curve from the time of dosing extrapolated to time infinity (AUCinf) for TORL-3-600(63 days)
Apparent volume of distribution during the terminal phase (Vz) of TORL-3-600(63 days)
Clearance (CL) of TORL-3-600(63 days)
Accumulation ratio (Rac) of TORL-3-600(63 days)