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
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* 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
* Radiologically measurable disease by RECIST v1.1
* Mandatory adequate tumor tissue sample available
* Must have recovered from all clinically relevant toxicities from previous cancer therapies (to at least Grade 1, except for alopecia)
Exclusion Criteria:
* 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
* Has a history of lung fibrosis or non-infectious interstitial lung disease (ILD)/pneumonitis that required steroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening
* Active corneal disease, or history of corneal disease within 12 months prior to enrollment
* Other unacceptable abnormalities, medications or procedures as defined by protocol
Primary outcome measure(s)
Ph1a: To determine the safety and tolerability of ADCX-020 — Start of treatment until 30 days after last dose Incidence and severity of treatment-emergent adverse events (TEAEs)
Ph1a: To determine the maximun tolerated dose (MTD) or recommended dose range for expansion and optimization — Start of treatment to end of DLT observation period Incidence of dose-limiting toxicities (DLTs) at different dose levels
Ph1b: To determine the recommended Phase 2 dose (RP2D) — Baseline to 30 days post last study drug administration Cumulative incidence and severity of TEAEs, preliminary anti-tumor activity and pharmacokinetics and -dynamics findings
Ph1b: To assess the objective response rate (ORR) of ADCX-020 — Baseline until the date of the first documented disease progression, death, or start of new anticancer therapy (approximately 24 months) Preliminary efficacy based on ORR assessed by Investigator using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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