Clinical trial · Interventional
Study of ZG006 in Participants With Neuroendocrine Prostate Cancer
A Phase II Study Evaluating the Preliminary Efficacy and Safety of ZG006 in Participants With Metastatic Neuroendocrine Prostate Cancer
NCT07024277CI-TRIAL-00091074not yet recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- 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)
This is a multicenter, open-label Phase II study, aimed at exploring the preliminary efficacy and safety of ZG006 in patients with advanced metastatic NEPC who have previously failed standard treatment.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Neuroendocrine Prostate Cancer | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ZG006 | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Part2
- description
- Participants will receive the RP2D identified in Part 1 of the study.
- interventionNames
- Biological: ZG006
- type
- EXPERIMENTAL
- label
- Part 1
- description
- The preliminary efficacy and safety of ZG006 at the two determined potential Phase II recommended doses (10 mg and 30 mg) will be assessed in Participants with advanced metastatic NEPC.
- interventionNames
- Biological: ZG006
Primary outcomes (1)
- measure
- Modified Best Overall Response(mBOR)
- timeFrame
- Baseline to 12 months
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Male Participants aged 18 to 80 years (inclusive); * Advanced metastatic neuroendocrine prostate cancer; * disease progression after at least one line of platinum-based systemic therapy or intolerance to toxicity; * Measurable disease according to RECIST v1.1 criteria; * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1. Exclusion Criteria: * Known positive test for human immunodeficiency virus (HIV) or hepatitis; * Patients were deemed unsuitable for participating in the study by the investigator for any reason.
References
Publications (0)
Data not yet available
No reference posted for this study.