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New treatment option for Advanced Malignancy
Official title ADCX-020 for the Treatment of Patients With Locally Advanced or Metastatic Cancers
ClinicalTrials.gov ID: NCT07238075
What this study is testing
What is ADCX-020?
ADCX-020 is an investigational medicine, being studied as a potential treatment for advanced malignancy.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Radiologically measurable disease by RECIST v1.1
You likely can't join if
- 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...
- 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...
- Active corneal disease, or history of corneal disease within 12 months prior to enrollment
See the full eligibility 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...
- 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)
- 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...
- Active corneal disease, or history of corneal disease within 12 months prior to enrollment
- Other unacceptable abnormalities, medications or procedures as defined by protocol
The study team makes the final eligibility decision.
Where it's taking place
- Sydney, New South Wales, Australia
- Birtinya, Queensland, Australia
- Southport, Queensland, Australia
- Adelaide, South Australia, Australia
- Nedlands, Western Australia, Australia
- Barcelona, Barcelona, Spain
- Madrid, Madrid, Spain
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Sydney, New South Wales, Australia; Birtinya, Queensland, Australia; Southport, Queensland, Australia; Adelaide, South Australia, Australia; Nedlands, Western Australia, Australia; Barcelona, Barcelona, Spain and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.