A Phase 1, First in Human, Dose-Escalation Study of TORL-2-307-MAB in Participants With Advanced Cancer

TORL Biotherapeutics, LLC8 sites in 2 countries70 target enrollmentJanuary 20, 2022

ConditionsAdvanced Solid Tumor Gastric Cancer Pancreas Cancer Gastroesophageal Junction Adenocarcinoma

InterventionsTORL-2-307-MAB

Overview

Phase: Phase 1
Intervention: TORL-2-307-MAB
Conditions: Advanced Solid Tumor
Sponsor: TORL Biotherapeutics, LLC
Enrollment: 70
Locations: 8
Primary Endpoint: Maximum Tolerated Dose (MTD)
Status: Active, not recruiting
Last Updated: last year

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-2-307-MAB in patients with advanced cancer

Registry

clinicaltrials.gov

Start Date

January 20, 2022

End Date

December 15, 2025

Last Updated

last year

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-2-307-MAB
•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-2-307-MAB

Intervention: TORL-2-307-MAB

Expansion as Monotherapy - Part 2

TORL-2-307-MAB

Intervention: TORL-2-307-MAB

Outcomes

Primary Outcomes

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

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

Recommended Phase 2 Dose (RP2D)

Time Frame: up to 2 years

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

Secondary Outcomes

Area under the Serum Concentration-Time curve from the time of dosing to the last measurable concentration (AUClast) for TORL-2-307-MAB(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-2-307-MAB (Cmax)(21 days)
Minimum Serum Concentration of TORL-2-307-MAB (Cmin)(21 days)
Maximum Serum Concentration of TORL-2-307-MAB at Steady State (Cmax,ss)(63 days)
Minimum Serum Concentration of TORL-2-307-MAB at Steady State (Cmin,ss)(63 days)
Time of Maximum Serum Concentration of TORL-2-307-MAB (Tmax)(21 days)
Time of Minimum Serum Concentration of TORL-2-307-MAB (Tmin)(21 days)
Time of Minimum Serum Concentration of TORL-2-307-MAB at Steady State (Tmin,ss)(63 days)
Terminal Half-life (t1/2) of Serum TORL-2-307-MAB(63 days)
Area under the Serum Concentration-Time curve from the time of dosing extrapolated to time infinity (AUCinf) for TORL-2-307-MAB(63 days)
Apparent volume of distribution during the terminal phase (Vz) of TORL-2-307-MAB(63 days)
Clearance (CL) of TORL-2-307-MAB(63 days)
Accumulation ratio (Rac) of TORL-2-307-MAB(63 days)