ADCX-020 for the Treatment of Patients With Locally Advanced or Metastatic Cancers
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorAdcytherix SAS
About this trial
The purpose of this first-in-human study is to explore the safety, pharmacokinetics and effects of the study drug ADCX-020 in patients with advanced and metastatic solid tumors. ADCX-020 is an investigational anticancer therapy called antibody drug conjugate.
This study is set up in multiple parts. In the first part of the study, participants receive increasing doses of ADCX-020. Then 2 or more doses will be assessed to identify the optimal dose. This optimal dose is subsequently evaluated for effect on different cancer types.
Eligibility criteria
Qualifiers
Male and female participants ≥ 18 years of age
Ph1a: Locally advanced or metastatic solid tumor relapsed or PD following local standard treatments, for which no standard treatment is available
Ph1b: Eligible patients should have only received prior lines of systemic therapy according to SoC in the advanced/metastatic setting (not counting neoadjuvant/adjuvant treatment if completed >6 months prior to recurrence)
Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
Disqualifiers
Known allergies/hypersensitivity/intolerance to or contraindication to exatecan, or any excipient
Phase 1b: Prior antibody drug conjugate exposure with a topoisomerase 1 inhibitor payload
Uncontrolled or significant cardiac disease including left ventricular ejection fraction (LVEF) <50%, myocardial infarction or uncontrolled/unstable angina
Has clinically active central nervous system (CNS) metastases
Trial design
Treatments tested in this trial
- ADCX-020
Treatment groups
290 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov