ADCX-020 treatment for advanced or metastatic solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This first-in-human, open-label Phase 1a/1b program uses dose escalation followed by dose optimization and cohort expansion to study ADCX-020 as a single agent in relapsed or refractory solid tumors. Phase 1a will escalate doses under a Dose Escalation Committee to identify the maximum tolerated dose and dose-limiting toxicities while characterizing pharmacokinetics and safety. Phase 1b will optimize dosing (two or more dose levels or regimens) and expand multiple cohorts at the recommended dose under a Safety Review Committee to collect pharmacodynamics and preliminary efficacy across selected tumor types. Eligible participants must have measurable disease by RECIST v1.1, ECOG 0–1, and provide mandatory tumor tissue for testing.

Why it matters

Who can join: the full rules

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

Where it's running

• Macquarie University
  Sydney, New South Wales, Australia Recruiting
• Blacktown Hospital
  Sydney, New South Wales, Australia Recruiting
• Sunshine Coast University Private Hospital
  Birtinya, Queensland, Australia Recruiting
• Tasman Oncology Research
  Southport, Queensland, Australia Recruiting
• Cancer Research SA
  Adelaide, South Australia, Australia Recruiting
• Linear Clinical Research
  Nedlands, Western Australia, Australia Recruiting

Study contacts

• Study coordinator: Adcytherix SAS
• Email: clinicaltrials@adcytherix.com
• Phone: +31 628839232

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.