ADCE-T02, a Tissue Factor Targeted Antibody-Drug Conjugate, in Patients With Selected Advanced Solid Tumours

Launched by ADCENDO APS · Sep 12, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called ADCE-T02, which is being tested for patients with advanced solid tumors that cannot be removed by surgery. The main goal of the trial is to find out the highest dose of ADCE-T02 that can be given safely, as well as to see how well it is tolerated by patients. This study is currently looking for participants aged 65 and older who have already received at least one other treatment for their cancer and have continued to experience disease progression. Participants should have measurable cancer lesions and good overall health, with an expected life expectancy of at least three months.

If you decide to participate, you will receive ADCE-T02 alone, and the study will closely monitor your health for any side effects. Additionally, women who can become pregnant and men are required to use effective birth control during the study and for some time after treatment to ensure safety. It’s important to note that not everyone can join this trial; for example, patients with certain heart conditions or previous treatments targeting a specific protein called Tissue Factor are excluded. Overall, this trial represents an opportunity to explore a potential new treatment option for patients with advanced solid tumors.

Gender

ALL

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
• • 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 history of malignancy other than inclusion diagnosis within five years prior to first dose of ADCE T02.