First-in-Human, Phase 1 Study of ADCE-T02, a Tissue Factor Targeted Antibody-Drug Conjugate, in Patients With Advanced Solid Tumors
Summary
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.
Arms & interventions
- DrugADCE-T02
Administered intravenously
Outcome measures
Primary
Maximum 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
Secondary
Overall Response Rate (ORR) according to the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Time frame: Up to 24 months
Disease Control Rate (DCR) according to the RECIST v1.1
Time frame: Up to 24 months
Progression-free Survival (PFS)
Time frame: Up to 24 months
Concentration of anti-drug antibodies (ADA)
Time frame: Up to 24 months
Maximum observed concentration (C[max])
Time frame: Up to 24 months
Area under the curve (AUC)
Time frame: Up to 24 months
Terminal half-life (t[1/2])
Time frame: Up to 24 months
Time to maximum concentration (Tmax)
Time frame: Up to 24 months
Eligibility criteria
Study locations (5)
Highlands Oncology Group
Rogers, Arkansas, 72758
Yale University Cancer Center
New Haven, Connecticut, 06520
Massachusetts General Hospital
Boston, Massachusetts, 02114
MD Anderson Cancer Center
Houston, Texas, 77030
START San Antonio
San Antonio, Texas, 78229
References
- Poulsen TT, Ilina O, Wardman JH, Bie A, Bornholdt J, Gillberg M, Pontieri D, Barkholt P, Come C, Zhang Y, Zhang J, Wang Y, Shi H, Liu SH, Meng X, Mumberg D. ADCE-T02 - a Next Generation Antibody Drug Conjugate Targeting Tissue Factor Demonstrates Superior Preclinical Efficacy and Tolerability. Mol Cancer Ther. 2026 Apr 17. doi: 10.1158/1535-7163.MCT-26-0045. Online ahead of print.(PubMed)