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

Advanced or Metastatic Solid Tumors Clinical Trial

— INCLINE-101  

Official title:

A Phase 1/2, Open Label, Dose Escalation and Expansion Study of TAC-001 in Patients With Select Advanced or Metastatic Solid Tumors

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05399654
• Other study ID #: INCLINE-101
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: June 28, 2022
• Est. completion date: May 19, 2026

Study information

• Verified date: January 2024
• Source: Tallac Therapeutics
• Contact: Kevin Heller, MD
• Phone: (650) 866-1966
• Email: tac-001safety[@]tallactx.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: May 19, 2026
• Est. primary completion date: January 27, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Advanced or Metastatic Solid Tumors
• Neoplasms

Intervention

Drug:
• TAC-001
TAC-001 is a Toll-like Receptor Agonist Antibody Conjugate (TRAAC)

Locations

Country	Name	City	State
Australia	Clinical Site	Nedlands	Western Australia
United States	University of Colorado	Aurora	Colorado
United States	Sarah Cannon Research Institute (SCRI)- Denver	Denver	Colorado
United States	NEXT Oncology- Virginia	Fairfax	Virginia
United States	West Cancer Center & Research Institute	Germantown	Tennessee
United States	John Theurer Cancer Center	Hackensack	New Jersey
United States	The University of Texas MD Anderson Cancer Center	Houston	Texas
United States	NEXT Oncology	Irving	Texas
United States	University of Southern California (USC)	Los Angeles	California
United States	Weill Cornell Medicine- NYU Clinical Cancer Center	New York	New York
United States	AdventHealth Cancer Institute	Orlando	Florida
United States	Sarah Cannon Research Institute (SCRI)- Florida Cancer Specialists and Research Institute, LLC	Orlando	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Tallac Therapeutics

Countries where clinical trial is conducted

United States,  Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	Maximum Plasma Concentration (Cmax)	To evaluate the Cmax of TAC-001 monotherapy	2 years
Secondary	Maximum Plasma Concentration (Tmax)	To evaluate the Tmax of TAC-001 monotherapy	2 years
Secondary	Area Under the Plasma Concentration-Time Curve (AUC)	To evaluate the AUC of TAC-001 monotherapy	2 years
Secondary	Terminal Half-Life	To evaluate the terminal half-life of TAC-001 monotherapy	2 years
Secondary	Clearance of TAC-001	To evaluate the drug clearance of TAC-001 monotherapy	2 years
Secondary	Evaluation of immunogenicity of TAC-001	Incidence of antidrug antibodies (ADA) against TAC-001	2 years