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

Running, not enrolling · Phase 1/Phase 2

Conditions studied: Advanced or Metastatic Solid Tumors

In brief

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.

Key facts

Study ID

NCT05399654

Run by

Tallac Therapeutics

People needed

72

Starts

2022-06-28

Expected to finish

2026-05-19

Last updated by the study team

2024-08-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically or cytologically-documented solid tumors.
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1.
• Demonstrate adequate organ function.

You may not qualify if…

• 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.

Where it is running

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

Full record on ClinicalTrials.gov

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