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First in Human Study of TORL-2-307-ADC 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: NCT05156866
Recruitment Status : Recruiting
First Posted : December 14, 2021
Last Update Posted : December 12, 2023
Sponsor:
Collaborator:
Translational Research in Oncology
Information provided by (Responsible Party):
TORL Biotherapeutics, LLC

Study Description
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Brief Summary:
This first-in-human study will evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of TORL-2-307-ADC in patients with advanced cancer

Condition or disease Intervention/treatment Phase
Advanced Solid Tumor Gastric Cancer Pancreas Cancer Gastroesophageal Junction Adenocarcinoma Drug: TORL-2-307-ADC Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1, First in Human, Dose-Escalation Study of TORL-2-307-ADC in Participants With Advanced Cancer
Actual Study Start Date : February 2, 2022
Estimated Primary Completion Date : January 15, 2025
Estimated Study Completion Date : January 15, 2026

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Monotherapy Dose Dose Finding - Part 1
TORL-2-307-ADC
 Drug: TORL-2-307-ADC
antibody drug conjugate
Experimental: Expansion as Monotherapy - Part 2
TORL-2-307-ADC
 Drug: TORL-2-307-ADC
antibody drug conjugate


Outcome Measures
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Primary Outcome Measures :
  1. 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

  2. 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

  3. Recommended Phase 2 Dose (RP2D) [ Time Frame: up to 2 years ]
    Based on the maximum tolerated dose, cumulative safety, and pharmacokinetic data


Secondary Outcome Measures :
  1. 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

  2. Duration of Response (DOR) [ Time Frame: up to 2 years ]
    Time from CR or PR to objective disease progression or death to any cause

  3. 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

  4. Time to Response (TTR) [ Time Frame: up to 2 years ]
    Time from start of treatment to complete response or partial response

  5. 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

  6. 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

  7. 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.

  8. Maximum Serum Concentration of TORL-2-307-ADC (Cmax) [ Time Frame: 21 days ]
    PK assessment

  9. Minimum Serum Concentration of TORL-2-307-ADC (Cmin) [ Time Frame: 21 days ]
    PK assessment

  10. Maximum Serum Concentration of TORL-2-307-ADC at Steady State (Cmax,ss) [ Time Frame: 63 days ]
    PK assessment

  11. Minimum Serum Concentration of TORL-2-307-ADC at Steady State (Cmin,ss) [ Time Frame: 63 days ]
    PK assessment

  12. Time of Maximum Serum Concentration of TORL-2-307-ADC (Tmax) [ Time Frame: 21 days ]
    PK assessment

  13. Time of Minimum Serum Concentration of TORL-2-307-ADC (Tmin) [ Time Frame: 21 days ]
    PK Assessment

  14. Time of Minimum Serum Concentration of TORL-2-307-ADC at Steady State (Tmin,ss) [ Time Frame: 63 days ]
    PK Assessment

  15. Terminal Half-life (t1/2) of Serum TORL-2-307-ADC [ Time Frame: 63 days ]
    PK Assessment

  16. 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

  17. 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

  18. Apparent volume of distribution during the terminal phase (Vz) of TORL-2-307-ADC [ Time Frame: 63 days ]
    PK Assessment

  19. Clearance (CL) of TORL-2-307-ADC [ Time Frame: 63 days ]
    PK Assessment

  20. Accumulation ratio (Rac) of TORL-2-307-ADC [ Time Frame: 63 days ]
    PK Assessment


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05156866


Contacts
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Contact: Stephen Letrent, PharmD, PhD 858-342-6652 stephen.letrent@torlbio.com

Locations
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United States, California
Providence St. Jude Medical Center Recruiting
Fullerton, California, United States, 92835
Contact: David J Park, MD         
UCLA - JCCC Clinical Research Unit Recruiting
Los Angeles, California, United States, 90095
Contact: Zev Wainberg, MD    310-586-2094      
Torrance Memorial Medical Recruiting
Torrance, California, United States, 90505
Contact: Hugo Hool, MD         
United States, Indiana
Fort Wayne Medical Oncology and Hematology Recruiting
Fort Wayne, Indiana, United States, 46804
Contact: Sunil Babu, MD         
Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of, 03080
Contact: Tae Yong Kim         
Severance Hospital, Yonsei University Health System Recruiting
Seoul, Korea, Republic of, 03722
Contact: Sun Young Rha         
Seoul National University Bundang Hospital Recruiting
Seoul, Korea, Republic of, 13620
Contact: Keun Wook Lee         
Sponsors and Collaborators
TORL Biotherapeutics, LLC
Translational Research in Oncology
Investigators
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Study Director: Stephen Letrent, PharmD, PhD TORL Biotherapeutics, LLC
More Information
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Responsible Party: TORL Biotherapeutics, LLC
ClinicalTrials.gov Identifier: NCT05156866    
Other Study ID Numbers: TORL2307ADC-001
First Posted: December 14, 2021    Key Record Dates
Last Update Posted: December 12, 2023
Last Verified: December 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by TORL Biotherapeutics, LLC:
claudin18.2
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Neoplasms
Digestive System Neoplasms
Neoplasms by Site
 Digestive System Diseases
Endocrine Gland Neoplasms
Pancreatic Diseases
Endocrine System Diseases