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

Official title

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

Overview

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.

Interventions

• Drug ADCE-T02
  Administered intravenously

Primary outcome measures

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

Secondary outcome measures (8)

• 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

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

Australia · 7 centers

• 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

United States · 5 centers

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

Publications

• 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

Identifiers

NCT: NCT06597721 · ADCE-T02-001

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗