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

August 14, 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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
72

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Australia
    • Western Australia
      • Nedlands, Western Australia, Australia, 6009
        • Clinical Site
  • United States
    • California
      • Los Angeles, California, United States, 90033
        • University of Southern California (USC)
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado
      • Denver, Colorado, United States, 80218
        • Sarah Cannon Research Institute (SCRI)- Denver
    • Florida
      • Orlando, Florida, United States, 32804
        • AdventHealth Cancer Institute
      • Orlando, Florida, United States, 32827
        • Sarah Cannon Research Institute (SCRI)- Florida Cancer Specialists and Research Institute, LLC
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • John Theurer Cancer Center
    • New York
      • New York, New York, United States, 10065
        • Weill Cornell Medicine- NYU Clinical Cancer Center
    • Tennessee
      • Germantown, Tennessee, United States, 38138
        • West Cancer Center & Research Institute
    • Texas
      • Houston, Texas, United States, 77030
        • The University of Texas MD Anderson Cancer Center
      • Irving, Texas, United States, 75039
        • NEXT Oncology
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • NEXT Oncology- Virginia

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: TAC-001 Single-Agent Dose-Escalation Cohorts
Drug: TAC-001
TAC-001 is a Toll-like Receptor Agonist Antibody Conjugate (TRAAC)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Tallac Therapeutics

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 28, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 27, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 19, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 19, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 26, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 1, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 16, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 14, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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