Actively Recruiting
ADCE-T02, a Tissue Factor Targeted Antibody-Drug Conjugate, in Patients With Selected Advanced Solid Tumours
Led by Adcendo ApS · Updated on 2026-04-17
210
Participants Needed
11
Research Sites
109 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
ADCE-T02, a Tissue Factor Targeted Antibody-Drug Conjugate, in Patients With Selected Advanced Solid Tumours
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 23 3 months.
- Patients must have adequate organ function as indicated by laboratory values
- Women of childbearing potential must agree to use two effective contraceptive methods during treatment and for 7 months after
- Male patients must agree to use condoms during treatment and for 4 months after
You will not qualify if you...
- 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 history of cicatricial conjunctivitis or inflammatory conditions predisposing 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 increased bleeding risk
- Significant cardiac disease including recent myocardial infarction, acute coronary syndromes, congestive heart failure, uncontrolled hypertension, or arrhythmias
- History of interstitial lung disease or pneumonitis requiring steroids, current or suspected ILD/pneumonitis
- Prior second malignancy except well-treated basal cell carcinoma or squamous cell carcinoma of the skin
- Low-risk prostate cancer with Gleason score < 7 and PSA < 10 ng/mL
- Any cancer or in situ cancer with disease-free period 23 2 years
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 11 locations
1
Highlands Oncology Group
Rogers, Arkansas, United States, 72758
Actively Recruiting
2
Yale University Cancer Center
New Haven, Connecticut, United States, 06520
Actively Recruiting
3
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
4
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
5
START San Antonio
San Antonio, Texas, United States, 78229
Actively Recruiting
6
Macquarie University Hospital
Macquarie Park, New South Wales, Australia, 2109
Actively Recruiting
7
Scientia Clinical Research
Randwick, New South Wales, Australia, 2031
Actively Recruiting
8
Southern Oncology Clinical Research Unit
Bedford Park, South Australia, Australia, 5042
Actively Recruiting
9
Peninsula and South Eastern Haematology and Oncology Group (PSEHOG)
Frankston, Victoria, Australia, 3199
Actively Recruiting
10
Cabrini Hospital
Malvern, Victoria, Australia, 3144
Actively Recruiting
11
Linear Clinical Research
Nedlands, Western Australia, Australia, 6009
Actively Recruiting
Research Team
M
Margaret Mcnaull
CONTACT
S
Sarah Berardini
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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