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

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: Active, not recruiting
• Conditions: Advanced or Metastatic Solid Tumors
• Intervention / Treatment: Drug: TAC-001

• Study Type: Interventional
• Enrollment (Actual): 72
• Phase: Phase 2; Phase 1

Contacts and Locations

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

Eligibility Criteria

• 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

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dose-Escalation Stage: RP2D for TAC-001	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	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	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	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)	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)	To evaluate the Cmax of TAC-001 monotherapy	2 years
Maximum Plasma Concentration (Tmax)	To evaluate the Tmax of TAC-001 monotherapy	2 years
Area Under the Plasma Concentration-Time Curve (AUC)	To evaluate the AUC of TAC-001 monotherapy	2 years
Terminal Half-Life	To evaluate the terminal half-life of TAC-001 monotherapy	2 years
Clearance of TAC-001	To evaluate the drug clearance of TAC-001 monotherapy	2 years
Evaluation of immunogenicity of TAC-001	Incidence of antidrug antibodies (ADA) against TAC-001	2 years

Collaborators and Investigators

• Sponsor: Tallac Therapeutics

Study record dates

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): August 16, 2024
• Last Update Submitted That Met QC Criteria: August 14, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• 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