RecruitingPhase 1NCT07238075

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

A First-in-human, Multicenter Dose Escalation and Multiple Cohort Expansion Phase 1a/b Study to Investigate Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of ADCX-020 in Participants With Locally Advanced or Metastatic Solid Tumors

Sponsor

Adcytherix SAS

Enrollment

290 participants

Start Date

Feb 14, 2026

Study Type

INTERVENTIONAL

Conditions

Metastatic Solid Tumors Advanced Solid Cancers Advanced Malignancy

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

Min Age: 18 Years

Inclusion Criteria7

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 Criteria7

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