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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 en…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Ph1a: To determine the safety and tolerability of ADCX-020
Timeframe: Start of treatment until 30 days after last dose
2
Ph1a: To determine the maximun tolerated dose (MTD) or recommended dose range for expansion and optimization
Timeframe: Start of treatment to end of DLT observation period
3
Ph1b: To determine the recommended Phase 2 dose (RP2D)
Timeframe: Baseline to 30 days post last study drug administration
4
Ph1b: To assess the objective response rate (ORR) of ADCX-020
Timeframe: Baseline until the date of the first documented disease progression, death, or start of new anticancer therapy (approximately 24 months)