Clinical trial NCT05399654: A Dose Escalation and Expansion Study of TAC-001 in Patients With Select Advanced or Metastatic Solid Tumors
Official title: A Phase 1/2, Open Label, Dose Escalation and Expansion Study of TAC-001 in Patients With Select Advanced or Metastatic Solid Tumors
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Advanced or Metastatic Solid Tumors
Lead sponsor: Tallac Therapeutics
Sponsor class: INDUSTRY
First posted: 2022-06-01
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Dose-Escalation Stage: RP2D for TAC-001
timeFrame: 2-years
measure: Dose Expansion: Characterization of ORR for TAC-001
timeFrame: 2 years
measure: Dose Expansion: Characterization of duration of response for TAC-001
timeFrame: 2 years
measure: Dose Expansion: Characterization of clinical benefit rate for TAC-001
timeFrame: 2 years
Secondary outcomes:
measure: Incidence and Severity of Nonserious Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: 2 years
measure: Maximum Plasma Concentration (Cmax)
timeFrame: 2 years
measure: Maximum Plasma Concentration (Tmax)
timeFrame: 2 years
measure: Area Under the Plasma Concentration-Time Curve (AUC)
timeFrame: 2 years
measure: Terminal Half-Life
timeFrame: 2 years
measure: Clearance of TAC-001
timeFrame: 2 years
measure: Evaluation of immunogenicity of TAC-001
timeFrame: 2 years
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of Southern California (USC)
state: California
city: Aurora
country: United States
facility: University of Colorado
state: Colorado
city: Denver
country: United States
facility: Sarah Cannon Research Institute (SCRI)- Denver
state: Colorado
city: Orlando
country: United States
facility: AdventHealth Cancer Institute
state: Florida
city: Orlando
country: United States
facility: Sarah Cannon Research Institute (SCRI)- Florida Cancer Specialists and Research Institute, LLC
state: Florida
city: Hackensack
country: United States
facility: John Theurer Cancer Center
state: New Jersey
city: New York
country: United States
facility: Weill Cornell Medicine- NYU Clinical Cancer Center
state: New York
city: Germantown
country: United States
facility: West Cancer Center & Research Institute
state: Tennessee
city: Houston
country: United States
facility: The University of Texas MD Anderson Cancer Center
state: Texas
city: Irving
country: United States
facility: NEXT Oncology
state: Texas
city: Fairfax
country: United States
facility: NEXT Oncology- Virginia
state: Virginia
city: Nedlands
country: Australia
facility: Clinical Site
state: Western Australia
Study officials:
References: