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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
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
Secondary ID [1] 0 0
INCLINE-101
Universal Trial Number (UTN)
Trial acronym
INCLINE-101
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced or Metastatic Solid Tumors 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Dose-Escalation Stage: RP2D for TAC-001
Timepoint [1] 0 0
2-years
Primary outcome [2] 0 0
Dose Expansion: Characterization of ORR for TAC-001
Timepoint [2] 0 0
2 years
Primary outcome [3] 0 0
Dose Expansion: Characterization of duration of response for TAC-001
Timepoint [3] 0 0
2 years
Primary outcome [4] 0 0
Dose Expansion: Characterization of clinical benefit rate for TAC-001
Timepoint [4] 0 0
2 years
Secondary outcome [1] 0 0
Incidence and Severity of Nonserious Adverse Events (AEs) and Serious Adverse Events (SAEs)
Timepoint [1] 0 0
2 years
Secondary outcome [2] 0 0
Maximum Plasma Concentration (Cmax)
Timepoint [2] 0 0
2 years
Secondary outcome [3] 0 0
Maximum Plasma Concentration (Tmax)
Timepoint [3] 0 0
2 years
Secondary outcome [4] 0 0
Area Under the Plasma Concentration-Time Curve (AUC)
Timepoint [4] 0 0
2 years
Secondary outcome [5] 0 0
Terminal Half-Life
Timepoint [5] 0 0
2 years
Secondary outcome [6] 0 0
Clearance of TAC-001
Timepoint [6] 0 0
2 years
Secondary outcome [7] 0 0
Evaluation of immunogenicity of TAC-001
Timepoint [7] 0 0
2 years

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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
28/06/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
19/05/2026
Actual
Sample size
Target
Accrual to date
Final
72
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 0 0
Clinical Site - Nedlands
Recruitment postcode(s) [1] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
New Jersey
Country [5] 0 0
United States of America
State/province [5] 0 0
New York
Country [6] 0 0
United States of America
State/province [6] 0 0
Tennessee
Country [7] 0 0
United States of America
State/province [7] 0 0
Texas
Country [8] 0 0
United States of America
State/province [8] 0 0
Virginia

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Tallac Therapeutics
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT05399654
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Kevin Heller, MD
Address 0 0
Country 0 0
Phone 0 0
(650) 866-1966
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05399654