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New treatment option for Advanced Solid Tumor
Official title ADCE-T02, a Tissue Factor Targeted Antibody-Drug Conjugate, in Patients With Selected Advanced Solid Tumours
ClinicalTrials.gov ID: NCT06597721
What this study is testing
What is ADCE-T02?
ADCE-T02 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for advanced solid tumor.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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.
You likely can't join if
- 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...
- 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...
See the full eligibility 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...
- 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
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Rogers, Arkansas, United States
- New Haven, Connecticut, United States
- Boston, Massachusetts, United States
- Houston, Texas, United States
- San Antonio, Texas, United States
- Macquarie Park, New South Wales, Australia
- Randwick, New South Wales, Australia
- Bedford Park, South Australia, Australia
- Frankston, Victoria, Australia
- Malvern, Victoria, Australia
- Melbourne, Victoria, Australia
- Nedlands, Western Australia, Australia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Rogers, Arkansas, United States; New Haven, Connecticut, United States; Boston, Massachusetts, United States; Houston, Texas, United States; San Antonio, Texas, United States; Macquarie Park, New South Wales, Australia and 6 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.