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RECRUITING Phase 1 ClinicalTrials.gov

ADCE-T02, a Tissue Factor Targeted Antibody-Drug Conjugate, in Patients With Selected Advanced Solid Tumours

Sponsor: Adcendo ApS • ClinicalTrials.gov ID: NCT06597721

Registry updated: 2026-09-09
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Description

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. The expansion phase is now open for enrollment in indications including HNSCC and PDAC.

Interventions

  • ADCE-T02 (Drug)
    Administered intravenously

Eligibility criteria

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 been naturally postmenopausal for at least 12 consecutive months must agree to use two effective contraceptive methods while on study treatment and for at least 7 months after the last dose of ADCE T02. 8. Male patients must agree to use condoms, even if they have had a successful vasectomy, while on study treatment and for at least 4 months after the last dose of ADCE T02. Key Exclusion Criteria: 1. Prior treatment with any agent targeting Tissue Factor or any ADC with a topoisomerase 1 payload 2. Central nervous system (CNS) metastasis. 3. Active ocular surface disease or a history of cicatricial conjunctivitis or inflammatory conditions that predispose to cicatrizing conjunctivitis, mucus pemphigoid or penetrating ocular transplants. 4. Persistent toxicities from previous systemic anti-neoplastic treatments 5. Known past or current coagulation defects leading to an increased risk of bleeding 6. Significant cardiac disease; recent myocardial infarction, acute coronary syndromes, congestive heart failure, uncontrolled hypertension, uncontrolled cardiac arrhythmias 7. History of (non-infectious) interstitial lung disease (ILD)/pneumonitis that required steroids, or current ILD/pneumonitis, or suspected ILD/pneumonitis 8. Prior second malignancy except for: * Well treated basal cell carcinoma or squamous cell carcinoma of the skin. * Low-risk prostate cancer with a Gleason score \< 7 and a PSA level \< 10 ng/mL * Any cancer or in situ cancer the patient has been disease-free for ≥ 2 years.

Conditions

Advanced Solid Tumor PDAC HNSCC

Locations

  • Highlands Oncology Group — Rogers, Arkansas, United States
  • Yale University Cancer Center — New Haven, Connecticut, United States
  • Massachusetts General Hospital — Boston, Massachusetts, United States
  • Washington University — St Louis, Missouri, United States
  • Memorial Sloan Kettering Cancer Center — New York, New York, United States
  • MD Anderson Cancer Center — Houston, Texas, United States
  • START San Antonio — San Antonio, Texas, United States
  • Macquarie University Hospital — Macquarie Park, New South Wales, Australia
  • Scientia Clinical Research — Randwick, New South Wales, Australia
  • Southern Oncology Clinical Research Unit — Bedford Park, South Australia, Australia
  • Peninsula and South Eastern Haematology and Oncology Group (PSEHOG) — Frankston, Victoria, Australia
  • Cabrini Hospital — Malvern, Victoria, Australia
  • Peter MacCallum Cancer Centre — Melbourne, Victoria, Australia
  • Linear Clinical Research — Nedlands, Western Australia, Australia
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record