Status:
RECRUITING
ADCE-T02, a Tissue Factor Targeted Antibody-Drug Conjugate, in Patients With Selected Advanced Solid Tumours
Lead Sponsor:
Adcendo ApS
Conditions:
Advanced Solid Tumor
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 ...
Eligibility Criteria
Inclusion
- Key
- 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.
- Key
Exclusion
- 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.
Key Trial Info
Start Date :
November 25 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
210 Patients enrolled
Trial Details
Trial ID
NCT06597721
Start Date
November 25 2024
End Date
December 31 2026
Last Update
November 13 2025
Active Locations (10)
Enter a location and click search to find clinical trials sorted by distance.
1
Highlands Oncology Group
Rogers, Arkansas, United States, 72758
2
Yale University Cancer Center
New Haven, Connecticut, United States, 06520
3
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
4
MD Anderson Cancer Center
Houston, Texas, United States, 77030