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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT05399654
Registration number
NCT05399654
Ethics application status
Date submitted
19/05/2022
Date registered
1/06/2022
Date last updated
16/08/2024
Titles & IDs
Public title
A Dose Escalation and Expansion Study of TAC-001 in Patients With Select Advanced or Metastatic Solid Tumors
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Scientific title
A Phase 1/2, Open Label, Dose Escalation and Expansion Study of TAC-001 in Patients With Select Advanced or Metastatic Solid Tumors
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Secondary ID [1]
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INCLINE-101
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Universal Trial Number (UTN)
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Trial acronym
INCLINE-101
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Advanced or Metastatic Solid Tumors
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - TAC-001
Treatment: Devices - Lung Sealant
Experimental: Collateral Ventilation Positive - Collateral Ventilation Positive participants will have the lung sealant applied and the endobronchial valve implant
Experimental: TAC-001 Single-Agent Dose-Escalation Cohorts -
Treatment: Drugs: TAC-001
TAC-001 is a Toll-like Receptor Agonist Antibody Conjugate (TRAAC)
Treatment: Devices: Lung Sealant
The Aeriseal System uses a polymer foam to block or seal fissures, peripheral airways, alveoli, and collateral channels to achieve lung volume reduction.
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Intervention code [1]
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Treatment: Drugs
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Intervention code [2]
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Treatment: Devices
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Dose-Escalation Stage: RP2D for TAC-001
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Assessment method [1]
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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
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Timepoint [1]
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2-years
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Primary outcome [2]
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Dose Expansion: Characterization of ORR for TAC-001
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Assessment method [2]
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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
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Timepoint [2]
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2 years
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Primary outcome [3]
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Dose Expansion: Characterization of duration of response for TAC-001
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Assessment method [3]
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To evaluate preliminary efficacy of TAC-001 by estimating the duration of response as assessed by the Investigator per RECIST 1.1 and iRECIST
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Timepoint [3]
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2 years
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Primary outcome [4]
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Dose Expansion: Characterization of clinical benefit rate for TAC-001
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Assessment method [4]
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To evaluate preliminary efficacy of TAC-001 by estimating the clinical benefit rate as assessed by the Investigator per RECIST 1.1 and iRECIST
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Timepoint [4]
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2 years
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Secondary outcome [1]
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Incidence and Severity of Nonserious Adverse Events (AEs) and Serious Adverse Events (SAEs)
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Assessment method [1]
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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
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Timepoint [1]
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2 years
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Secondary outcome [2]
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Maximum Plasma Concentration (Cmax)
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Assessment method [2]
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To evaluate the Cmax of TAC-001 monotherapy
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Timepoint [2]
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2 years
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Secondary outcome [3]
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Maximum Plasma Concentration (Tmax)
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Assessment method [3]
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To evaluate the Tmax of TAC-001 monotherapy
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Timepoint [3]
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2 years
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Secondary outcome [4]
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Area Under the Plasma Concentration-Time Curve (AUC)
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Assessment method [4]
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To evaluate the AUC of TAC-001 monotherapy
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Timepoint [4]
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2 years
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Secondary outcome [5]
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Terminal Half-Life
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Assessment method [5]
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To evaluate the terminal half-life of TAC-001 monotherapy
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Timepoint [5]
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2 years
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Secondary outcome [6]
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Clearance of TAC-001
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Assessment method [6]
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To evaluate the drug clearance of TAC-001 monotherapy
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Timepoint [6]
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2 years
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Secondary outcome [7]
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Evaluation of immunogenicity of TAC-001
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Assessment method [7]
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Incidence of antidrug antibodies (ADA) against TAC-001
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Timepoint [7]
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2 years
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Eligibility
Key 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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
NA
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
28/06/2022
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
19/05/2026
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Actual
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Sample size
Target
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Accrual to date
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Final
72
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Recruitment in Australia
Recruitment state(s)
WA
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Recruitment hospital [1]
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Clinical Site - Nedlands
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Recruitment postcode(s) [1]
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6009 - Nedlands
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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California
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Country [2]
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United States of America
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State/province [2]
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Colorado
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Country [3]
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United States of America
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State/province [3]
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Florida
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Country [4]
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United States of America
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State/province [4]
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New Jersey
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Country [5]
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United States of America
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State/province [5]
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New York
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Country [6]
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United States of America
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State/province [6]
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Tennessee
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Country [7]
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United States of America
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State/province [7]
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Texas
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Country [8]
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United States of America
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State/province [8]
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Virginia
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Tallac Therapeutics
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Address
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Country
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT05399654
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Kevin Heller, MD
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Address
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Country
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Phone
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(650) 866-1966
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Fax
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Email
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[email protected]
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT05399654
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