Actively Recruiting
ADCX-020 for the Treatment of Patients With Locally Advanced or Metastatic Cancers
Led by Adcytherix SAS · Updated on 2026-02-17
290
Participants Needed
4
Research Sites
197 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
ADCX-020 for the Treatment of Patients With Locally Advanced or Metastatic Cancers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male and female participants aged 18 years or older
- Phase 1a: Participants with locally advanced or metastatic solid tumors that have relapsed or progressed after local standard treatments and have no available standard treatment
- Phase 1b: Participants who have received prior systemic therapies per standard of care in the advanced or metastatic setting, excluding neoadjuvant/adjuvant treatments completed more than 6 months before recurrence
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Radiologically measurable disease according to RECIST v1.1 criteria
- Availability of an adequate tumor tissue sample
- Recovery from all clinically relevant toxicities of previous cancer therapies to at least Grade 1, except for alopecia
You will not qualify if you...
- Known allergies, hypersensitivity, intolerance, or contraindication to exatecan or any excipient
- Phase 1b: Previous exposure to antibody drug conjugates with a topoisomerase 1 inhibitor payload
- Uncontrolled or significant cardiac disease including left ventricular ejection fraction below 50%, recent myocardial infarction, or unstable angina
- Presence of clinically active central nervous system metastases
- History of lung fibrosis, non-infectious interstitial lung disease or pneumonitis requiring steroids, current interstitial lung disease or pneumonitis, or suspected interstitial lung disease/pneumonitis not ruled out by imaging
- Active corneal disease or history of corneal disease within 12 months before enrollment
- Other unacceptable abnormalities, medications, or procedures as defined by the study protocol
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 4 locations
1
Macquarie University
Sydney, New South Wales, Australia, 2109
Not Yet Recruiting
2
Blacktown Hospital
Sydney, New South Wales, Australia, 2148
Not Yet Recruiting
3
Sunshine Coast University Private Hospital
Birtinya, Queensland, Australia, 4575
Actively Recruiting
4
Cancer Research SA
Adelaide, South Australia, Australia, 5000
Not Yet Recruiting
Research Team
A
Adcytherix SAS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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