ADCX-020 treatment for advanced or metastatic solid tumors
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
This trial will test ADCX-020, an antibody–drug conjugate, in adults with advanced or metastatic solid tumors who have run out of standard treatment options.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 290 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Adcytherix SAS Industry-sponsored |
| Locations | 4 sites (Sydney, New South Wales and 3 other locations) |
| Trial ID | NCT07238075 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults aged 18 or older with measurable, locally advanced or metastatic solid tumors that progressed after standard therapies, ECOG performance status 0–1, and available tumor tissue are the intended candidates.
Not a fit: Patients with known hypersensitivity to exatecan or its excipients, uncontrolled significant cardiac disease, poor performance status, or (for Phase 1b) prior exposure to ADCs carrying a topoisomerase I payload may not receive benefit.
Why it matters
Potential benefit: If successful, ADCX-020 could shrink tumors or control disease in patients who have exhausted approved treatment options.
How similar studies have performed: Other antibody–drug conjugates carrying topoisomerase I inhibitors (for example trastuzumab deruxtecan and sacituzumab govitecan) have shown meaningful activity in several solid tumors, but ADCX-020 is being tested here in humans for the first time.
Eligibility criteria
Show full inclusion / exclusion 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 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 this trial is running
Sydney, New South Wales and 3 other locations
- Macquarie University — Sydney, New South Wales, Australia (Not_yet_recruiting)
- Blacktown Hospital — Sydney, New South Wales, Australia (Not_yet_recruiting)
- Sunshine Coast University Private Hospital — Birtinya, Queensland, Australia (Recruiting)
- Cancer Research SA — Adelaide, South Australia, Australia (Not_yet_recruiting)
Study contacts
- Study coordinator: Adcytherix SAS
- Email: clinicaltrials@adcytherix.com
- Phone: +31 628839232
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.