Actively Recruiting
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
Led by Adcytherix SAS · Updated on 2026-06-08
290
Participants Needed
9
Research Sites
17 weeks
Total Duration
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AI-Summary
What this Trial Is About
Researchers are studying ADCX-020, an investigational antibody drug conjugate, in patients with advanced or metastatic solid tumors that have relapsed or are refractory to standard treatments. This first-in-human Phase 1a/b trial aims to evaluate the safety, tolerability, pharmacokinetics, and early effectiveness of ADCX-020 in these patients. The study is sponsored by Adcytherix SAS and includes patients who have measurable disease and meet specific health criteria. The study has two main parts: Phase 1a involves dose escalation where participants receive increasing doses of ADCX-020 intravenously to find the maximum tolerated dose. Phase 1b focuses on dose optimization and expansion, assessing two or more dose levels or dosing regimens in different patient groups to determine the recommended Phase 2 dose. Both phases are overseen by expert committees to ensure safety and appropriate dose selection. Participants will be monitored from the start of treatment through follow-up periods that can extend up to about 24 months. Researchers will assess safety and tolerability, measure drug levels in the blood, and evaluate tumor responses using imaging criteria. They will also track progression, survival, and immune reactions to the drug. Study visits include clinical evaluations, tumor assessments, and laboratory tests to carefully monitor participants' health and treatment effects.
CONDITIONS
Brief 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 18 years of age or older
- Locally advanced or metastatic solid tumor relapsed or progressed following local standard treatments with no available standard treatment (Phase 1a)
- For Phase 1b, prior systemic therapy for advanced/metastatic disease according to standard of care, excluding neoadjuvant/adjuvant treatment completed more than 6 months before recurrence
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Radiologically measurable disease based on RECIST v1.1
- Availability of adequate tumor tissue sample
- Recovery from all clinically relevant toxicities of previous cancer therapies to at least Grade 1, except alopecia
You will not qualify if you...
- Known allergies, hypersensitivity, or intolerance to exatecan or any excipient
- Prior exposure to antibody drug conjugates with a topoisomerase 1 inhibitor payload (Phase 1b)
- Uncontrolled or significant cardiac disease including left ventricular ejection fraction below 50%, myocardial infarction, or unstable angina
- Active central nervous system metastases
- History of lung fibrosis or non-infectious interstitial lung disease/pneumonitis requiring steroids, current interstitial lung disease/pneumonitis, or suspected cases not ruled out by imaging
- Active corneal disease or history of corneal disease within 12 months prior to enrollment
- Other unacceptable abnormalities, medications, or procedures as defined by the protocol
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to approximately 24 months depending on disease progression or discontinuation
Participants receive escalating doses of ADCX-020 in Phase 1a or dose optimization and expansion in Phase 1b to investigate safety, tolerability, and efficacy.
Regular visits during dosing and assessment periods
Duration - 30 days after last dose
Participants are monitored for safety and treatment effects for 30 days after the last dose of ADCX-020.
1 to 2 visits for safety follow-up
Trial Site Locations
Total: 9 locations
1
Macquarie University
Sydney, New South Wales, Australia, 2109
Actively Recruiting
2
Blacktown Hospital
Sydney, New South Wales, Australia, 2148
Actively Recruiting
3
Sunshine Coast University Private Hospital
Birtinya, Queensland, Australia, 4575
Actively Recruiting
4
Tasman Oncology Research
Southport, Queensland, Australia, 4215
Actively Recruiting
5
Cancer Research SA
Adelaide, South Australia, Australia, 5000
Actively Recruiting
6
Linear Clinical Research
Nedlands, Western Australia, Australia, 6009
Actively Recruiting
7
START Barcelona
Barcelona, Barcelona, Spain, 08023
Actively Recruiting
8
START Madrid FJD
Madrid, Madrid, Spain, 28040
Actively Recruiting
9
START Madrid CIOCC
Madrid, Madrid, Spain, 28050
Actively Recruiting
Research Team
A
Adcytherix SAS
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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