ADCE-T02, a Tissue Factor Targeted Antibody-Drug Conjugate, in Patients With Selected Advanced Solid Tumours
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.
The expansion phase is now open for enrollment in indications including HNSCC and PDAC.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
ADCE-T02
DrugAdministered intravenously
Treatment groups
210 Participants
are divided into 1 treatment groupGroup A: ADCE-T02 Dose Escalation followed by an Expansion PhaseExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Maximum Tolerated Dose (MTD) of ADCE-T02
The MTD will be determined using DLTs
Time frame
Up to 24 months2
Recommended Expansion Phase Dose (RED) of ADCE-T02
The RED will be determined using dose limiting toxicities (DLTs) and all other available study data
Time frame
Up to 24 months3
Type, incidence and severity of Adverse Events
Safety and tolerability profile of ADCE-T02 assessed by the Common Terminology Criteria for Adverse Events v5.0
Time frame
Up to 24 monthsSecondary outcomes
1
Overall Response Rate (ORR) according to the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Proportion of patients achieving Complete Response (CR) or Partial Response (PR)
Time frame
Up to 24 months2
Disease Control Rate (DCR) according to the RECIST v1.1
Proportion of patients achieving CR, PR or Stable Disease (SD)
Time frame
Up to 24 months3
Progression-free Survival (PFS)
Time from date of start of treatment to date of the first progression or death, whichever occurs first.
Time frame
Up to 24 months4
Concentration of anti-drug antibodies (ADA)
Immunogenicity profile characterized by concentration of ADAs
Time frame
Up to 24 monthsSponsors and contacts
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Source ClinicalTrials.gov