NCT06597721 ADCE-T02, a Tissue Factor Targeted Antibody-Drug Conjugate, in Patients With Selected Advanced Solid Tumours
| NCT ID | NCT06597721 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Adcendo ApS |
| Condition | Advanced Solid Tumor |
| Study Type | INTERVENTIONAL |
| Enrollment | 210 participants |
| Start Date | 2024-11-25 |
| Primary Completion | 2027-03-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 210 participants in total. It began in 2024-11-25 with a primary completion date of 2027-03-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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. The expansion phase is now open for enrollment in indications including HNSCC and PDAC.
Eligibility Criteria
Key Inclusion Criteria: 1. Patients must have pathologically confirmed unresectable advanced solid tumor 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. Key Exclusion Criteria: 1. Prior treatment with any agent targeting Tissue Factor or any ADC with a topoisomerase 1 payload 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06597721 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Advanced Solid Tumor. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06597721 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06597721 currently recruiting?
Yes, NCT06597721 is actively recruiting participants. Contact the research team at Sherri.Paxton@adcendo.com for enrollment information.
Where is the NCT06597721 trial being conducted?
This trial is being conducted at Rogers, United States, New Haven, United States, Boston, United States, St Louis, United States and 10 additional locations.
Who is sponsoring the NCT06597721 clinical trial?
NCT06597721 is sponsored by Adcendo ApS. The trial plans to enroll 210 participants.