Clinical trial · Interventional
EMD 525797 in Subjects With Asymptomatic or Mildly Symptomatic Metastatic Castrate-resistant Prostate Cancer
A Randomized, Double-blind, Placebo-controlled, Multicenter Phase II Trial Investigating Two Doses of EMD 525797 in Subjects With Asymptomatic or Mildly Symptomatic Metastatic Castrate-resistant Prostate Cancer (mCRPC)
- 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 primary objective of the trial is to evaluate the clinical anti-tumor activity of EMD 525797 administered as 1-hour intravenous infusion every 3 weeks in terms of progression free survival (PFS) time in subjects with asymptomatic or mildly symptomatic metastatic castrate-resistant prostate cancer (mCRPC).
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 |
|---|---|---|---|
| Prostate Cancer Metastatic | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| EMD 525797 | Drug | — | UNRESOLVED |
| Placebo | Other | — | UNRESOLVED |
| Standard of Care (SoC) | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- PLACEBO_COMPARATOR
- label
- Placebo + Standard of care (SoC)
- interventionNames
- Other: Placebo
- Other: Standard of Care (SoC)
- type
- EXPERIMENTAL
- label
- EMD 525797 750 mg + SoC
- interventionNames
- Drug: EMD 525797
- Other: Standard of Care (SoC)
- type
- EXPERIMENTAL
- label
- EMD 525797 1500 mg + SoC
- interventionNames
- Drug: EMD 525797
- Other: Standard of Care (SoC)
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically or cytologically confirmed adenocarcinoma of the prostate (Gleason score) * Bisphosphonate treatment * Stable, ongoing adequate testosterone suppression proven by hypogonadal levels of testosterone (less than or equal to) \<= 50 nanogram per deciliter \[ng/dL\]) for subjects without surgical castration (luteinizing hormone-releasing hormone antagonists and agonists) * Other protocol defined inclusion criteria could apply Exclusion Criteria: * Prior chemotherapy, biologic therapy (targeted therapy), or any experimental therapy for mCRPC * Chronic and ongoing treatment with opioids * Acute pathologic fracture, spinal cord compression, or hypercalcemia at Screening * Visceral metastasis, brain metastasis * Radiotherapy to bone lesions and/or orthopedic surgery for pathologic fractures. Any kinds of major elective surgery within 30 days prior to trial treatment * Other protocol defined exclusion criteria could apply
References
Publications (0)
Data not yet available