NCT07238075 ADCX-020 for the Treatment of Patients With Locally Advanced or Metastatic Cancers

Trial Parameters

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

Brief Summary

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

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

Related Trials