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CompletedLast updated: 21 December 2023

ES414: This phase I study is testing the effect of drug MOR209/ES414 in treating patients with metastatic prostate cancerA Phase 1 Study of MOR209/ES414 in Patients Wtih Metastatic Castration-Resistant Prostate Cancer

Clinical summary

Summary

The study will be conducted in 2 Stages. The primary objective of Stage 1 of the study is to identify the maximum tolerated dose (MTD) of MOR209/ES414 administered intravenously to patients with mCRPC. Secondary objectives are to evaluate the tolerability, pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity, cytokine response, and clinical activity of MOR209/ES414. The primary objective of Stage 2 of the study is to evaluate the clinical activity of MOR209/ES414 in patients that have or have not received prior chemotherapy. Secondary objectives are to further characterize the safety profile, PK, PD, and immunogenicity of MOR209/ES414.

Conditions

This trial is treating patients with castration resistant prostate cancer.

Cancer

Urinary System Cancers Genitourinary

Age

People18+

Phase

I

Trial Acronym

ES414

More information

Trial Identifiers

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Trial sponsor

Emergent Product Development Seattle LLC

Scientific Title

A Phase 1 Study of MOR209/ES414 in Patients Wtih Metastatic Castration-Resistant Prostate Cancer

Eligibility

Inclusion

  • Histologically or cytologically confirmed adenocarcinoma of the prostate. No evidence of neuroendocrine differentiation or small cell features.
  • Surgically or medically castrated, with testosterone ≤ 50 ng/dL (≤ 1.7 nmol/L).
  • Progressive prostate cancer by either serum PSA levels, soft tissue or bone disease as defined by the PCWG2 criteria.
  • In Stage 1, patients may or may not have received prior chemotherapy for mCRPC. In Stage 2, patients will be enrolled into two cohorts based on whether or not they have received prior chemotherapy for mCRPC. Any prior chemotherapy must have been completed ≥ 4 weeks prior to administration of ES414. Additionally, in countries where abiraterone or enzalutamide are commercially available, patients in Stage 1 and 2 must have progressed on abiraterone and/or enzalutamide prior to study entry.
  • ECOG ≤ 1
  • Life expectancy > 6 months per investigator
  • Adequate hematologic, renal, and hepatic parameters

Exclusion

  • Any chemotherapy, sipuleucel-T, or investigational drug in prior 4 weeks, or abiraterone or enzalutamide in prior 2 week
  • Any radiation therapy in prior 2 weeks
  • Any prior therapy targeted against PSMA
  • History of seizures
  • History of central nervous system metastasis
  • History of nephrotic syndrome
  • Spot urine total protein:creatinine ratio >1,000 mg/gm
  • Planned palliative procedures for alleviation of bone pain
  • Active infection requiring treatment with systemic anti-infectives or major surgery in prior 4 weeks.
  • Any prednisone (or equivalent corticosteroids) use within 2 weeks of study entry
  • Chronic immunosuppressive therapy
  • Known history of HIV, hepatitis B, or hepatitis C infection
  • Evidence of severe or uncontrolled systemic diseases
  • History of bleeding disorders or thromboembolic events in prior 3 months

Inclusion

  • You have had a certain type of treatment or surgical procedure.
  • Your cancer has spread to other parts of the body.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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