Advanced or Metastatic Solid Tumors Clinical Trial
— INCLINE-101Official title:
A Phase 1/2, Open Label, Dose Escalation and Expansion Study of TAC-001 in Patients With Select Advanced or Metastatic Solid Tumors
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.
Status | Recruiting |
Enrollment | 200 |
Est. completion date | May 19, 2026 |
Est. primary completion date | January 27, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Australia | Clinical Site | Nedlands | Western Australia |
United States | University of Colorado | Aurora | Colorado |
United States | Sarah Cannon Research Institute (SCRI)- Denver | Denver | Colorado |
United States | NEXT Oncology- Virginia | Fairfax | Virginia |
United States | West Cancer Center & Research Institute | Germantown | Tennessee |
United States | John Theurer Cancer Center | Hackensack | New Jersey |
United States | The University of Texas MD Anderson Cancer Center | Houston | Texas |
United States | NEXT Oncology | Irving | Texas |
United States | University of Southern California (USC) | Los Angeles | California |
United States | Weill Cornell Medicine- NYU Clinical Cancer Center | New York | New York |
United States | AdventHealth Cancer Institute | Orlando | Florida |
United States | Sarah Cannon Research Institute (SCRI)- Florida Cancer Specialists and Research Institute, LLC | Orlando | Florida |
Lead Sponsor | Collaborator |
---|---|
Tallac Therapeutics |
United States, Australia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | 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 | |
Secondary | Maximum Plasma Concentration (Cmax) | To evaluate the Cmax of TAC-001 monotherapy | 2 years | |
Secondary | Maximum Plasma Concentration (Tmax) | To evaluate the Tmax of TAC-001 monotherapy | 2 years | |
Secondary | Area Under the Plasma Concentration-Time Curve (AUC) | To evaluate the AUC of TAC-001 monotherapy | 2 years | |
Secondary | Terminal Half-Life | To evaluate the terminal half-life of TAC-001 monotherapy | 2 years | |
Secondary | Clearance of TAC-001 | To evaluate the drug clearance of TAC-001 monotherapy | 2 years | |
Secondary | Evaluation of immunogenicity of TAC-001 | Incidence of antidrug antibodies (ADA) against TAC-001 | 2 years |
Status | Clinical Trial | Phase | |
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