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

Study Overview
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Brief Summary
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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.

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

Conditions
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Advanced or Metastatic Solid Tumors

Intervention / Treatment
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* Drug: TAC-001


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically or cytologically-documented solid tumors. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1. Demonstrate adequate organ function. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TAC-001 Single-Agent Dose-Escalation Cohorts<br> | Drug: TAC-001<br>* TAC-001 is a Toll-like Receptor Agonist Antibody Conjugate (TRAAC)<br>|

What is the study measuring?
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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 |