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

Официальное название

First-in-Human, Phase 1 Study of ADCE-T02, a Tissue Factor Targeted Antibody-Drug Conjugate, in Patients With Advanced Solid Tumors

Обзор

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.

Вмешательства

• Препарат ADCE-T02
  Administered intravenously

Первичные конечные точки

• Maximum Tolerated Dose (MTD) of ADCE-T02 [Срок оценки: Up to 24 months]
• Recommended Expansion Phase Dose (RED) of ADCE-T02 [Срок оценки: Up to 24 months]
• Type, incidence and severity of Adverse Events [Срок оценки: Up to 24 months]

Вторичные конечные точки (8)

• Overall Response Rate (ORR) according to the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 [Срок оценки: Up to 24 months]
• Disease Control Rate (DCR) according to the RECIST v1.1 [Срок оценки: Up to 24 months]
• Progression-free Survival (PFS) [Срок оценки: Up to 24 months]
• Concentration of anti-drug antibodies (ADA) [Срок оценки: Up to 24 months]
• Maximum observed concentration (C[max]) [Срок оценки: Up to 24 months]
• Area under the curve (AUC) [Срок оценки: Up to 24 months]
• Terminal half-life (t[1/2]) [Срок оценки: Up to 24 months]
• Time to maximum concentration (Tmax) [Срок оценки: Up to 24 months]

Критерии участия

Критерии включения

• Patients must have pathologically confirmed unresectable advanced solid tumor
• Patients who have undergone at least one systemic therapy and have progressive disease
• Patients must have at least one measurable lesion as per RECIST version 1.1.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
• Life expectancy ≥ 3 months.
• Patients must have adequate organ function as indicated by laboratory values
• 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.
• 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.

Критерии исключения

• Prior treatment with any agent targeting Tissue Factor or any ADC with a topoisomerase 1 payload
• Central nervous system (CNS) metastasis.
• Active ocular surface disease or a history of cicatricial conjunctivitis or inflammatory conditions that predispose to cicatrizing conjunctivitis, mucus pemphigoid or penetrating ocular transplants.
• Persistent toxicities from previous systemic anti-neoplastic treatments
• Known past or current coagulation defects leading to an increased risk of bleeding
• Significant cardiac disease; recent myocardial infarction, acute coronary syndromes, congestive heart failure, uncontrolled hypertension, uncontrolled cardiac arrhythmias
• History of (non-infectious) interstitial lung disease (ILD)/pneumonitis that required steroids, or current ILD/pneumonitis, or suspected ILD/pneumonitis
• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Австралия · 7 центров

• Macquarie University Hospital — Macquarie Park
• Scientia Clinical Research — Randwick
• Southern Oncology Clinical Research Unit — Bedford Park
• Peninsula and South Eastern Haematology and Oncology Group (PSEHOG) — Frankston
• Cabrini Hospital — Malvern
• Peter MacCallum Cancer Centre — Melbourne
• Linear Clinical Research — Nedlands

США · 5 центров

• Highlands Oncology Group — Rogers
• Yale University Cancer Center — New Haven
• Massachusetts General Hospital — Boston
• MD Anderson Cancer Center — Houston
• START San Antonio — San Antonio

Публикации

• 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. PMID 41996633

Идентификаторы

NCT: NCT06597721 · ADCE-T02-001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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