ADCE-T02, a Tissue Factor Targeted Antibody-Drug Conjugate, in Patients With Selected Advanced Solid Tumours
NCT ID: NCT06597721
Last Updated: 2025-11-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
210 participants
INTERVENTIONAL
2024-11-25
2026-12-31
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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ADCE-T02 Dose Escalation followed by an Expansion Phase
ADCE-T02
Administered intravenously
Interventions
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ADCE-T02
Administered intravenously
Eligibility Criteria
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Inclusion Criteria
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.
Exclusion Criteria
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.
18 Years
ALL
No
Sponsors
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Adcendo ApS
INDUSTRY
Responsible Party
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Locations
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Highlands Oncology Group
Rogers, Arkansas, United States
Yale University Cancer Center
New Haven, Connecticut, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
MD Anderson Cancer Center
Houston, Texas, United States
START San Antonio
San Antonio, Texas, United States
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
Linear Clinical Research
Nedlands, Western Australia, Australia
Countries
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Central Contacts
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Other Identifiers
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ADCE-T02-001
Identifier Type: -
Identifier Source: org_study_id