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
This trial does not accept healthy volunteersQualifiers
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
Design model
Sequential
Treatments tested in this trial
ADCX-020
DrugADC
Treatment groups
290 Participants
are divided into 2 treatment groupsGroup A: Phase 1a ADCX-020Experimental treatment 1 intervention
Group B: Phase 1b: ADCX-020Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Ph1a: To determine the safety and tolerability of ADCX-020
Incidence and severity of treatment-emergent adverse events (TEAEs)
Time frame
Start of treatment until 30 days after last dose2
Ph1a: To determine the maximun tolerated dose (MTD) or recommended dose range for expansion and optimization
Incidence of dose-limiting toxicities (DLTs) at different dose levels
Time frame
Start of treatment to end of DLT observation period3
Ph1b: To determine the recommended Phase 2 dose (RP2D)
Cumulative incidence and severity of TEAEs, preliminary anti-tumor activity and pharmacokinetics and -dynamics findings
Time frame
Baseline to 30 days post last study drug administration4
Ph1b: To assess the objective response rate (ORR) of ADCX-020
Preliminary efficacy based on ORR assessed by Investigator using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Time frame
Baseline until the date of the first documented disease progression, death, or start of new anticancer therapy (approximately 24 months)Secondary outcomes
1
To evaluate duration of objective response (DoR)
DoR is defined as the time from first documented response to the date of first PD or death due to any cause
Time frame
Baseline until approximately 24 months2
To evaluate the disease control rate (DCR)
DCR is defined as the proportion of participants who achieved an objective response or stable disease, per RECIST v1.1.
Time frame
Baseline until approximately 24 months3
To assess prgression free survival (PFS)
PFS is defined as the time from first dose date to the date of first documented disease progression per RECIST v1.1 or death due to any cause
Time frame
Baseline until approximately 24 months4
Phase 1b: To evaluate overall survival (OS)
OS as time from study start to the date of death due to any cause
Time frame
Baseline to approximately 24 monthsSponsors and contacts
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Source ClinicalTrials.gov