A Dose Escalation and Expansion Study of TAC-001 in Patients With Select Advanced or Metastatic Solid Tumors
- Conditions
- Advanced or Metastatic Solid Tumors
- Interventions
- Registration Number
- NCT05399654
- Lead Sponsor
- Tallac Therapeutics
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 72
- Histologically or cytologically-documented solid tumors.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1.
- Demonstrate adequate organ function.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description TAC-001 Single-Agent Dose-Escalation Cohorts TAC-001 -
- Primary Outcome Measures
Name Time Method Dose-Escalation Stage: RP2D for TAC-001 2-years 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
Dose Expansion: Characterization of ORR for TAC-001 2 years 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
Dose Expansion: Characterization of duration of response for TAC-001 2 years To evaluate preliminary efficacy of TAC-001 by estimating the duration of response as assessed by the Investigator per RECIST 1.1 and iRECIST
Dose Expansion: Characterization of clinical benefit rate for TAC-001 2 years To evaluate preliminary efficacy of TAC-001 by estimating the clinical benefit rate as assessed by the Investigator per RECIST 1.1 and iRECIST
- Secondary Outcome Measures
Name Time Method Area Under the Plasma Concentration-Time Curve (AUC) 2 years To evaluate the AUC of TAC-001 monotherapy
Terminal Half-Life 2 years To evaluate the terminal half-life of TAC-001 monotherapy
Maximum Plasma Concentration (Cmax) 2 years To evaluate the Cmax of TAC-001 monotherapy
Maximum Plasma Concentration (Tmax) 2 years To evaluate the Tmax of TAC-001 monotherapy
Incidence and Severity of Nonserious Adverse Events (AEs) and Serious Adverse Events (SAEs) 2 years 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
Clearance of TAC-001 2 years To evaluate the drug clearance of TAC-001 monotherapy
Evaluation of immunogenicity of TAC-001 2 years Incidence of antidrug antibodies (ADA) against TAC-001
Trial Locations
- Locations (12)
John Theurer Cancer Center
🇺🇸Hackensack, New Jersey, United States
NEXT Oncology- Virginia
🇺🇸Fairfax, Virginia, 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
West Cancer Center & Research Institute
🇺🇸Germantown, Tennessee, United States
NEXT Oncology
🇺🇸Irving, Texas, United States
Clinical Site
🇦🇺Nedlands, Western Australia, Australia
University of Colorado
🇺🇸Aurora, Colorado, United States
Sarah Cannon Research Institute (SCRI)- Denver
🇺🇸Denver, Colorado, United States
The University of Texas MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
AdventHealth Cancer Institute
🇺🇸Orlando, Florida, United States
Sarah Cannon Research Institute (SCRI)- Florida Cancer Specialists and Research Institute, LLC
🇺🇸Orlando, Florida, United States