- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05399654
A Dose Escalation and Expansion Study of TAC-001 in Patients With Select Advanced or Metastatic Solid Tumors (INCLINE-101)
January 18, 2024 updated by: Tallac Therapeutics
A Phase 1/2, Open Label, Dose Escalation and Expansion Study of TAC-001 in Patients With Select Advanced or Metastatic Solid Tumors
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
200
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Kevin Heller, MD
- Phone Number: (650) 866-1966
- Email: tac-001safety@tallactx.com
Study Contact Backup
- Name: Colleen Oliver
- Email: Colleen@Tallactx.com
Study Locations
-
-
Western Australia
-
Nedlands, Western Australia, Australia, 6009
- Active, not recruiting
- Clinical Site
-
-
-
-
California
-
Los Angeles, California, United States, 90033
- Recruiting
- University of Southern California (USC)
-
Principal Investigator:
- Anthony El-Khoueiry, MD
-
-
Colorado
-
Aurora, Colorado, United States, 80045
- Recruiting
- University of Colorado
-
Principal Investigator:
- Sunnie Kim, MD
-
Denver, Colorado, United States, 80218
- Recruiting
- Sarah Cannon Research Institute (SCRI)- Denver
-
Principal Investigator:
- Jason Henry, MD
-
-
Florida
-
Orlando, Florida, United States, 32804
- Recruiting
- AdventHealth Cancer Institute
-
Principal Investigator:
- Guru Sonpavde, MD
-
Orlando, Florida, United States, 32827
- Recruiting
- Sarah Cannon Research Institute (SCRI)- Florida Cancer Specialists and Research Institute, LLC
-
Principal Investigator:
- Cesar Perez, MD
-
-
New Jersey
-
Hackensack, New Jersey, United States, 07601
- Recruiting
- John Theurer Cancer Center
-
Principal Investigator:
- Martin Guiterrez, MD
-
-
New York
-
New York, New York, United States, 10065
- Recruiting
- Weill Cornell Medicine- NYU Clinical Cancer Center
-
Contact:
- Dominique Leone
- Email: dol4002@med.cornell.edu
-
Principal Investigator:
- Anna Pavlick, MD
-
-
Tennessee
-
Germantown, Tennessee, United States, 38138
- Recruiting
- West Cancer Center & Research Institute
-
Principal Investigator:
- Daniel Vaena, MD
-
-
Texas
-
Houston, Texas, United States, 77030
- Recruiting
- The University of Texas Md Anderson Cancer Center
-
Principal Investigator:
- Sarina Piha-Paul, MD
-
Irving, Texas, United States, 75039
- Recruiting
- NEXT Oncology
-
Principal Investigator:
- Shiraj Sen, MD
-
-
Virginia
-
Fairfax, Virginia, United States, 22031
- Recruiting
- NEXT Oncology- Virginia
-
Principal Investigator:
- Alexander Spira, MD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Histologically or cytologically-documented solid tumors.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1.
- Demonstrate adequate organ function.
Exclusion Criteria:
- Prior history of or active malignant disease other than that being treated in this study.
- Known brain metastases or cranial epidural disease.
- A known hypersensitivity to the components of the study therapy or its' analogs.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: TAC-001 Single-Agent Dose-Escalation Cohorts
|
TAC-001 is a Toll-like Receptor Agonist Antibody Conjugate (TRAAC)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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-years
|
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
|
2 years
|
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
|
2 years
|
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
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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 years
|
Maximum Plasma Concentration (Cmax)
Time Frame: 2 years
|
To evaluate the Cmax of TAC-001 monotherapy
|
2 years
|
Maximum Plasma Concentration (Tmax)
Time Frame: 2 years
|
To evaluate the Tmax of TAC-001 monotherapy
|
2 years
|
Area Under the Plasma Concentration-Time Curve (AUC)
Time Frame: 2 years
|
To evaluate the AUC of TAC-001 monotherapy
|
2 years
|
Terminal Half-Life
Time Frame: 2 years
|
To evaluate the terminal half-life of TAC-001 monotherapy
|
2 years
|
Clearance of TAC-001
Time Frame: 2 years
|
To evaluate the drug clearance of TAC-001 monotherapy
|
2 years
|
Evaluation of immunogenicity of TAC-001
Time Frame: 2 years
|
Incidence of antidrug antibodies (ADA) against TAC-001
|
2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 28, 2022
Primary Completion (Estimated)
January 27, 2026
Study Completion (Estimated)
May 19, 2026
Study Registration Dates
First Submitted
May 19, 2022
First Submitted That Met QC Criteria
May 26, 2022
First Posted (Actual)
June 1, 2022
Study Record Updates
Last Update Posted (Actual)
January 22, 2024
Last Update Submitted That Met QC Criteria
January 18, 2024
Last Verified
January 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- INCLINE-101
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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