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A Dose Escalation and Expansion Study of TAC-001 in Patients With Select Advanced or Metastatic Solid Tumors (INCLINE-101)

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ClinicalTrials.gov Identifier: NCT05399654
Recruitment Status : Recruiting
First Posted : June 1, 2022
Last Update Posted : March 9, 2023
Sponsor:
Information provided by (Responsible Party):
Tallac Therapeutics

Study Description
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Brief Summary:
INCLINE-101 is an open label, multicenter Phase 1/2 study designed to evaluate safety, pharmacokinetics (PK), and preliminary anti-tumor activity of TAC-001 administered intravenously.

Condition or disease Intervention/treatment Phase
Advanced or Metastatic Solid Tumors Drug: TAC-001 Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1/2, Open Label, Dose Escalation and Expansion Study of TAC-001 in Patients With Select Advanced or Metastatic Solid Tumors
Actual Study Start Date : June 28, 2022
Estimated Primary Completion Date : January 27, 2026
Estimated Study Completion Date : May 19, 2026

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: TAC-001 Single-Agent Dose-Escalation Cohorts Drug: TAC-001
TAC-001 is a Toll-like Receptor Agonist Antibody Conjugate (TRAAC)


Outcome Measures
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Primary Outcome Measures :
  1. Dose-Escalation Stage: RP2D for TAC-001 [ Time Frame: 2-years ]
    To identify the recommended dose phase 2 dose (RP2D) for further evaluation of TAC-001 when administered as monotherapy in subjects with advanced or metastatic solid tumors

  2. Dose Expansion: Characterization of ORR for TAC-001 [ Time Frame: 2 years ]
    To evaluate preliminary efficacy of TAC-001 by estimating the overall response rate (ORR; combined complete response [CR] and partial response [PR]) as assessed by the Investigator per RECIST 1.1 and iRECIST

  3. Dose Expansion: Characterization of duration of response for TAC-001 [ Time Frame: 2 years ]
    To evaluate preliminary efficacy of TAC-001 by estimating the duration of response as assessed by the Investigator per RECIST 1.1 and iRECIST

  4. Dose Expansion: Characterization of clinical benefit rate for TAC-001 [ Time Frame: 2 years ]
    To evaluate preliminary efficacy of TAC-001 by estimating the clinical benefit rate as assessed by the Investigator per RECIST 1.1 and iRECIST


Secondary Outcome Measures :
  1. Incidence and Severity of Nonserious Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: 2 years ]
    To evaluate the safety of TAC-001 monotherapy through the evaluation of incidence and severity of nonserious AEs and SAEs, including immune-related adverse events (irAEs), as graded by investigators according to CTCAE version 5.0

  2. Maximum Plasma Concentration (Cmax) [ Time Frame: 2 years ]
    To evaluate the Cmax of TAC-001 monotherapy

  3. Maximum Plasma Concentration (Tmax) [ Time Frame: 2 years ]
    To evaluate the Tmax of TAC-001 monotherapy

  4. Area Under the Plasma Concentration-Time Curve (AUC) [ Time Frame: 2 years ]
    To evaluate the AUC of TAC-001 monotherapy

  5. Terminal Half-Life [ Time Frame: 2 years ]
    To evaluate the terminal half-life of TAC-001 monotherapy

  6. Clearance of TAC-001 [ Time Frame: 2 years ]
    To evaluate the drug clearance of TAC-001 monotherapy

  7. Evaluation of immunogenicity of TAC-001 [ Time Frame: 2 years ]
    Incidence of antidrug antibodies (ADA) against TAC-001


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:

  1. Histologically or cytologically-documented solid tumors.
  2. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1.
  3. Demonstrate adequate organ function.

Exclusion Criteria:

  1. Prior history of or active malignant disease other than that being treated in this study.
  2. Known brain metastases or cranial epidural disease.
  3. A known hypersensitivity to the components of the study therapy or its' analogs.
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): NCT05399654


Contacts
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Contact: Kevin Heller, MD (650) 866-1966 tac-001safety@tallactx.com

Locations
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United States, California
Clinical Site Recruiting
Los Angeles, California, United States, 90033
United States, Colorado
Clinical Site Recruiting
Aurora, Colorado, United States, 80045
Clinical Site Recruiting
Denver, Colorado, United States, 80218
United States, Florida
Clinical Site Recruiting
Orlando, Florida, United States, 32827
Australia, Western Australia
Clinical Site Recruiting
Nedlands, Western Australia, Australia, 6009
Sponsors and Collaborators
Tallac Therapeutics
More Information
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Responsible Party: Tallac Therapeutics
ClinicalTrials.gov Identifier: NCT05399654    
Other Study ID Numbers: INCLINE-101
First Posted: June 1, 2022    Key Record Dates
Last Update Posted: March 9, 2023
Last Verified: March 2023

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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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Neoplasms