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

Sponsor: Tallac Therapeutics

Sponsor score: 0

ClinicalTrials ID:NCT05399654

INCLINE-101 is a Phase 1/2 open-label, multicenter study assessing TAC-001, a Toll-like Receptor Agonist Antibody Conjugate, for safety, pharmacokinetics, and anti-tumor activity. Eligible participants must have documented solid tumors, an ECOG performance status of 0 or 1, and adequate organ function. TAC-001 is administered intravenously.

Patient Parameters

Program Overview

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.

Eligibility Criteria

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.

Locations

FACILITYZIPCITYSTATE
University of Southern California (USC)90033Los AngelesCalifornia
University of Colorado80045AuroraColorado
Sarah Cannon Research Institute (SCRI)- Denver80218DenverColorado
AdventHealth Cancer Institute32804OrlandoFlorida
Sarah Cannon Research Institute (SCRI)- Florida Cancer Specialists and Research Institute, LLC32827OrlandoFlorida
John Theurer Cancer Center07601HackensackNew Jersey
Weill Cornell Medicine- NYU Clinical Cancer Center10065New YorkNew York
West Cancer Center & Research Institute38138GermantownTennessee
The University of Texas MD Anderson Cancer Center77030HoustonTexas
NEXT Oncology75039IrvingTexas

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