We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Try the New Site
We're building a modernized ClinicalTrials.gov! Visit Beta.ClinicalTrials.gov to try the new functionality.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05159440
Recruitment Status : Recruiting
First Posted : December 16, 2021
Last Update Posted : March 6, 2023
Sponsor:
Collaborator:
Translational Research in Oncology
Information provided by (Responsible Party):
TORL Biotherapeutics, LLC

Tracking Information
First Submitted Date  ICMJE December 1, 2021
First Posted Date  ICMJE December 16, 2021
Last Update Posted Date March 6, 2023
Actual Study Start Date  ICMJE January 20, 2022
Estimated Primary Completion Date December 15, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 1, 2021)
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 1, 2021)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE First in Human Study of TORL-2-307-MAB in Participants With Advanced Cancer
Official Title  ICMJE A Phase 1, First in Human, Dose-Escalation Study of TORL-2-307-MAB in Participants With Advanced Cancer
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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Advanced Solid Tumor
  • Gastric Cancer
  • Pancreas Cancer
  • Gastroesophageal Junction Adenocarcinoma
Intervention  ICMJE Drug: TORL-2-307-MAB
monoclonal antibody
Study Arms  ICMJE
  • Experimental: Monotherapy Dose Dose Finding - Part 1
    TORL-2-307-MAB
    Intervention: Drug: TORL-2-307-MAB
  • Experimental: Expansion as Monotherapy - Part 2
    TORL-2-307-MAB
    Intervention: Drug: TORL-2-307-MAB
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 1, 2021)		 70
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 15, 2025
Estimated Primary Completion Date December 15, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Stephen Letrent, PharmD, PhD 858-342-6652 stephen.letrent@torlbio.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05159440
Other Study ID Numbers  ICMJE TORL2307MAB-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party TORL Biotherapeutics, LLC
Original Responsible Party Same as current
Current Study Sponsor  ICMJE TORL Biotherapeutics, LLC
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Translational Research in Oncology
Investigators  ICMJE
Study Director: Stephen Letrent, PharmD, PhD TORL Biotherapeutics, LLC
PRS Account TORL Biotherapeutics, LLC
Verification Date March 2023

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP