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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TAC-001 Single-Agent Dose-Escalation Cohorts | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TAC-001 | Drug | TAC-001 is a Toll-like Receptor Agonist Antibody Conjugate (TRAAC) |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Southern California (USC) | Los Angeles | California | 90033 | United States | ||
| University of Colorado |
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| 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 |
| Aurora |
| Colorado |
| 80045 |
| United States |
| Sarah Cannon Research Institute (SCRI)- Denver | Denver | Colorado | 80218 | United States |
| AdventHealth Cancer Institute | Orlando | Florida | 32804 | United States |
| Sarah Cannon Research Institute (SCRI)- Florida Cancer Specialists and Research Institute, LLC | Orlando | Florida | 32827 | United States |
| John Theurer Cancer Center | Hackensack | New Jersey | 07601 | United States |
| Weill Cornell Medicine- NYU Clinical Cancer Center | New York | New York | 10065 | United States |
| West Cancer Center & Research Institute | Germantown | Tennessee | 38138 | United States |
| The University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| NEXT Oncology | Irving | Texas | 75039 | United States |
| NEXT Oncology- Virginia | Fairfax | Virginia | 22031 | United States |
| Clinical Site | Nedlands | Western Australia | 6009 | Australia |