Clinical trial · Interventional
A Study of D4064A Administered to Patients With Recurrent or Persistent Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer
A Phase I, Open-Label, Dose-Escalation Study of the Safety and Pharmacokinetics of D4064A Administered Intravenously to Patients With Recurrent or Persistent Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer After a Platinum-Containing Regimen
- 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 Phase I, multicenter, open-label, dose-escalation study of single-agent D4064A administered by IV infusion to patients with recurrent or persistent epithelial ovarian cancer (EOC), primary peritoneal cancer (PPC), and fallopian tube cancer (FTC) who have previously received a platinum-containing regimen. The study will enroll up to 56 patients at up to six investigative sites in the United States.
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 |
|---|---|---|---|
| Fallopian Tube Cancer | Malignant Fallopian Tube Neoplasm | ALIAS | 0.90 |
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
| Peritoneal Cancer | Malignant Peritoneal Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| D4064A | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Incidence and nature of dose-limiting toxicities (DLTs)
- timeFrame
- Length of study
Secondary outcomes (3)
- measure
- Incidence, nature, and severity of adverse events
- timeFrame
- Length of study
- measure
- Incidence of anti-D4064A antibodies
- timeFrame
- Length of study
- measure
- Changes in vital signs and clinical laboratory results
- timeFrame
- Length of study
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * ECOG performance status of 0 or 1 * Advanced, histologically documented epithelial ovarian, primary peritoneal, or fallopian tube cancer that has progressed or relapsed during or within 12 months of treatment with a platinum-containing chemotherapy regimen, and for which no standard therapy exists * History of receiving five or fewer prior chemotherapy-containing regimens for EOC, PPC, or FTC (including primary therapy) Exclusion Criteria: * Prior treatment with chemotherapy or experimental anti-cancer agents within 4 weeks prior to Day 1 * Prior treatment with oregovomab (OvaRex(R)) or abagovomab * History or clinical evidence of central nervous system or brain metastases * Grade ≥ 2 peripheral neuropathy * History of severe allergic or anaphylactic reactions to human, humanized, chimeric, or murine monoclonal antibodies * History of clinically symptomatic liver disease, including viral or other hepatitis, history of or current alcoholism, or cirrhosis * Untreated or persistent/recurrent malignancy (other than EOC, PPC, or FTC)
References
Publications (0)
Data not yet available