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First in Human Study of TORL-1-23 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: NCT05103683
Recruitment Status : Recruiting
First Posted : November 2, 2021
Last Update Posted : June 10, 2022
Sponsor:
Collaborator:
Translational Research in Oncology
Information provided by (Responsible Party):
TORL Biotherapeutics, LLC

Brief Summary:
This first-in-human study will evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of TORL-1-23 in patients with advanced cancer

Condition or disease Intervention/treatment Phase
Advanced Solid Tumor Ovarian Cancer Endometrial Cancer Drug: TORL-1-23 Phase 1

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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-1-23 in Participants With Advanced Cancer
Actual Study Start Date : November 17, 2021
Estimated Primary Completion Date : November 15, 2024
Estimated Study Completion Date : November 15, 2025

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Monotherapy Dose Dose Finding - Part 1
TORL-1-23
Drug: TORL-1-23
antibody drug conjugate (ADC)

Experimental: Expansion as Monotherapy - Part 2
TORL-1-23
Drug: TORL-1-23
antibody drug conjugate (ADC)




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-1-23 (Cmax) [ Time Frame: 21 days ]
    PK assessment

  9. Minimum Serum Concentration of TORL-1-23 (Cmin) [ Time Frame: 21 days ]
    PK assessment

  10. Maximum Serum Concentration of TORL-1-23 at Steady State (Cmax,ss) [ Time Frame: 63 days ]
    PK assessment

  11. Minimum Serum Concentration of TORL-1-23 at Steady State (Cmin,ss) [ Time Frame: 63 days ]
    PK assessment

  12. Time of Maximum Serum Concentration of TORL-1-23 (Tmax) [ Time Frame: 21 days ]
    PK assessment

  13. Time of Minimum Serum Concentration of TORL-1-23 (Tmin) [ Time Frame: 21 days ]
    PK Assessment

  14. Time of Minimum Serum Concentration of TORL-1-23 at Steady State (Tmin,ss) [ Time Frame: 63 days ]
    PK Assessment

  15. Terminal Half-life (t1/2) of Serum TORL-1-23 [ 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-1-23 [ Time Frame: 63 days ]
    PK Assessment

  19. Clearance (CL) of TORL-1-23 [ Time Frame: 63 days ]
    PK Assessment

  20. Accumulation ratio (Rac) of TORL-1-23 [ Time Frame: 63 days ]
    PK Assessment



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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-1-23
  • 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

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): NCT05103683


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
UCLA - JCCC Clinical Research Unit Recruiting
Los Angeles, California, United States, 90095
Contact: Gottfried Konecny, MD    310-794-4955      
Principal Investigator: Gottfired Konecny, MD         
United States, Minnesota
University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Boris Winterhoff, MD, PhD    612-624-8003      
Principal Investigator: Boris Winterhoff, MD, PhD         
Mayo Clinic in Rochester Not yet recruiting
Rochester, Minnesota, United States, 55905
Contact: Andrea Wahner Hendrickson, MD    855-776-0015      
Principal Investigator: Andrea Wahner Hendrickson, MD         
Sponsors and Collaborators
TORL Biotherapeutics, LLC
Translational Research in Oncology
Investigators
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Study Director: Stephen Letrent, PharmD, PhD TORL Biotherapeutics, LLC
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Responsible Party: TORL Biotherapeutics, LLC
ClinicalTrials.gov Identifier: NCT05103683    
Other Study ID Numbers: TORL123-001
First Posted: November 2, 2021    Key Record Dates
Last Update Posted: June 10, 2022
Last Verified: June 2022
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
Additional relevant MeSH terms:
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Endometrial Neoplasms
Neoplasms by Site
Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Uterine Neoplasms
Uterine Diseases