Clinical trial · Interventional
ADCX-020 for the Treatment of Patients With Locally Advanced or Metastatic Cancers
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Malignancy | Malignant Neoplasm | CURATED_BROADER | 0.78 |
| Advanced Solid Cancers | Malignant Solid Neoplasm | CURATED_BROADER | 0.78 |
| Metastatic Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ADCX-020 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Phase 1a ADCX-020
- description
- Dose escalation of ADCX-020, intravenous
- interventionNames
- Drug: ADCX-020
- type
- EXPERIMENTAL
- label
- Phase 1b: ADCX-020
- description
- Dose optimization and expansion of ADCX-020, intravenous
- interventionNames
- Drug: ADCX-020
Primary outcomes (4)
- measure
- Ph1a: To determine the safety and tolerability of ADCX-020
- timeFrame
- Start of treatment until 30 days after last dose
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available