ADCE-T02, a Tissue Factor Targeted Antibody-Drug Conjugate, in Patients With Selected Advanced Solid Tumours
ConditionAdvanced Solid Tumor
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorAdcendo ApS
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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
Trial design
Treatments tested in this trial
- ADCE-T02
Treatment groups
210 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov