First in Human Study of TORL-2-307-MAB in Participants With Advanced Cancer

Overview

This first-in-human study will evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of TORL-2-307-MAB in patients with advanced cancer

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Sequential Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 15, 2024

Interventions

  • Drug: TORL-2-307-MAB
    • monoclonal antibody

Arms, Groups and Cohorts

  • Experimental: Monotherapy Dose Dose Finding – Part 1
    • TORL-2-307-MAB
  • Experimental: Expansion as Monotherapy – Part 2
    • TORL-2-307-MAB

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • Objective Response Rate (ORR)
    • Time Frame: up to 2 years
    • Percentage of participants with best response of complete response (CR) or partial response (PR) according to RECIST 1.1
  • Duration of Response (DOR)
    • Time Frame: up to 2 years
    • Time from CR or PR to objective disease progression or death to any cause
  • Progression Free Survival (PFS)
    • Time Frame: up to 2 years
    • PFS is defined as the time from the start of the treatment until objective disease progression or death from any cause
  • Time to Response (TTR)
    • Time Frame: up to 2 years
    • Time from start of treatment to complete response or partial response
  • 1 Year Overall Survival (1YOS)
    • Time Frame: 1 year
    • Proportion of participants alive at 1 year from the start of treatment to death from any cause
  • 2 Year Overall Survival (2YOS)
    • Time Frame: 2 years
    • Proportion of participants alive at 2 years from the start of treatment to death from any cause
  • Number of anti-drug antibody (ADA) Positive Participants
    • Time Frame: up to 2 years
    • Immunogenicity will be measured by the number of participants that are ADA positive.
  • Maximum Serum Concentration of TORL-2-307-MAB (Cmax)
    • Time Frame: 21 days
    • PK assessment
  • Minimum Serum Concentration of TORL-2-307-MAB (Cmin)
    • Time Frame: 21 days
    • PK assessment
  • Maximum Serum Concentration of TORL-2-307-MAB at Steady State (Cmax,ss)
    • Time Frame: 63 days
    • PK assessment
  • Minimum Serum Concentration of TORL-2-307-MAB at Steady State (Cmin,ss)
    • Time Frame: 63 days
    • PK assessment
  • Time of Maximum Serum Concentration of TORL-2-307-MAB (Tmax)
    • Time Frame: 21 days
    • PK assessment
  • Time of Minimum Serum Concentration of TORL-2-307-MAB (Tmin)
    • Time Frame: 21 days
    • PK Assessment
  • Time of Minimum Serum Concentration of TORL-2-307-MAB at Steady State (Tmin,ss)
    • Time Frame: 63 days
    • PK Assessment
  • Terminal Half-life (t1/2) of Serum TORL-2-307-MAB
    • Time Frame: 63 days
    • PK Assessment
  • Area under the Serum Concentration-Time curve from the time of dosing to the last measurable concentration (AUClast) for TORL-1-23
    • Time Frame: 21 days
    • PK Assessment
  • Area under the Serum Concentration-Time curve from the time of dosing extrapolated to time infinity (AUCinf) for TORL-1-23
    • Time Frame: 63 days
    • PK Assessment
  • Apparent volume of distribution during the terminal phase (Vz) of TORL-2-307-MAB
    • Time Frame: 63 days
    • PK Assessment
  • Clearance (CL) of TORL-2-307-MAB
    • Time Frame: 63 days
    • PK Assessment
  • Accumulation ratio (Rac) of TORL-2-307-MAB
    • Time Frame: 63 days
    • PK Assessment

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • TORL Biotherapeutics, LLC
  • Collaborator
    • Translational Research in Oncology
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Stephen Letrent, PharmD, PhD, Study Director, TORL Biotherapeutics, LLC
  • Overall Contact(s)
    • Stephen Letrent, PharmD, PhD, 858-342-6652, stephen.letrent@torlbio.com

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.