First-in-Human, Phase 1 Study of ADCE-T02, a Tissue Factor Targeted Antibody-Drug Conjugate, in Patients With Advanced Solid Tumors
Adcendo ApS
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Key Inclusion Criteria: 1. Patients must have pathologically confirmed unresectable advanced solid tumor 2. Patients who have undergone at least one systemic therapy and have progressive disease 3. Patients must have at least one measurable lesion as per RECIST version 1.1. 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. 5. Life expectancy ≥ 3 months. 6. Patients must have adequate organ function as indicated by laboratory values 7. Women of childbearing potential (WCBP), defined as sexually mature women who have not undergone surgical sterilization or who have not bee…
Interventions
- DrugADCE-T02
Administered intravenously
Locations (11)
- Highlands Oncology GroupRogers, Arkansas
- Yale University Cancer CenterNew Haven, Connecticut
- Massachusetts General HospitalBoston, Massachusetts
- MD Anderson Cancer CenterHouston, Texas
- START San AntonioSan Antonio, Texas
- Macquarie University HospitalMacquarie Park, New South Wales