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

Tallac Therapeutics72 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Advanced or Metastatic Solid Tumors

Interventions

TAC-001DRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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 (12)

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

Outcomes

Primary Outcomes

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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 2 years

Secondary Outcomes

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

Time frame: 2 years

Maximum Plasma Concentration (Cmax)

To evaluate the Cmax of TAC-001 monotherapy

Time frame: 2 years

Data from ClinicalTrials.gov

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