Adcendo ApS is conducting a phase 1 study of an investigational drug called ADCE-T02 (previously known as AMT-754), a tissue factor targeted antibody-drug conjugate which may be used in the future as a possible treatment for advanced solid tumors. The main purpose of the study is to determine the Maximum Tolerated Dose (MTD), the recommended dose and the safety and tolerability of ADCE-T02 when given as a single therapy over a range of different dose levels.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
210
Administered intravenously
Highlands Oncology Group
Rogers, Arkansas, United States
RECRUITINGYale University Cancer Center
New Haven, Connecticut, United States
RECRUITINGMaximum Tolerated Dose (MTD) of ADCE-T02
The MTD will be determined using DLTs
Time frame: Up to 24 months
Recommended Expansion Phase Dose (RED) of ADCE-T02
The RED will be determined using dose limiting toxicities (DLTs) and all other available study data
Time frame: Up to 24 months
Type, incidence and severity of Adverse Events
Safety and tolerability profile of ADCE-T02 assessed by the Common Terminology Criteria for Adverse Events v5.0
Time frame: Up to 24 months
Overall Response Rate (ORR) according to the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Proportion of patients achieving Complete Response (CR) or Partial Response (PR)
Time frame: Up to 24 months
Disease Control Rate (DCR) according to the RECIST v1.1
Proportion of patients achieving CR, PR or Stable Disease (SD)
Time frame: Up to 24 months
Progression-free Survival (PFS)
Time from date of start of treatment to date of the first progression or death, whichever occurs first.
Time frame: Up to 24 months
Concentration of anti-drug antibodies (ADA)
Immunogenicity profile characterized by concentration of ADAs
Time frame: Up to 24 months
Maximum observed concentration (C[max])
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Massachusetts General Hospital
Boston, Massachusetts, United States
RECRUITINGMD Anderson Cancer Center
Houston, Texas, United States
RECRUITINGSTART San Antonio
San Antonio, Texas, United States
RECRUITINGScientia Clinical Research
Randwick, New South Wales, Australia
RECRUITINGSouthern Oncology Clinical Research Unit
Bedford Park, South Australia, Australia
RECRUITINGPeninsula and South Eastern Haematology and Oncology Group (PSEHOG)
Frankston, Victoria, Australia
RECRUITINGCabrini Hospital
Malvern, Victoria, Australia
RECRUITINGLinear Clinical Research
Nedlands, Western Australia, Australia
RECRUITINGPharmacokinetic profile characterized by the maximum observed concentration (C\[max\]) of ADCE-T02
Time frame: Up to 24 months
Area under the curve (AUC)
Pharmacokinetic profile characterized by the area under the curve (AUC) of ADCE-T02
Time frame: Up to 24 months
Terminal half-life (t[1/2])
Pharmacokinetic profile characterized by the terminal half-life (t\[1/2\]) of ADCE-T02
Time frame: Up to 24 months
Time to maximum concentration (Tmax)
Pharmacokinetic profile characterized by the time to maximum concentration (Tmax)
Time frame: Up to 24 months