Clinical trial · Interventional
A Study of the Safety and Pharmacokinetics of AGS-8M4 Given in Combination With Chemotherapy in Women With Ovarian Cancer
A Phase 1b, Parallel Arm, Multicenter, Open-Label Study of the Safety and Pharmacokinetics of AGS-8M4 Given in Combination With Two Different Chemotherapy Regimens in Women With Platinum Resistant or Platinum Sensitive Ovarian Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Trial was terminated to allow sponsors to evaluate the future development of the drug program
Summary
Brief summary (as posted)
This is a parallel arm study to evaluate AGS-8M4 administered in combination with chemotherapy in subjects with ovarian cancer. AGS-8M4 will be administered as an IV infusion until disease worsens.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carcinoma | Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
| Ovarian Diseases | — | UNRESOLVED | — |
| Ovarian Neoplasms | Ovarian Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| AGS-8M4 | Biological | — | UNRESOLVED |
| carboplatin | Drug | Carboplatin | ALIAS |
| gemcitabine | Drug | Gemcitabine | ALIAS |
| Pegylated liposomal doxorubicin (PLD) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- A. PLD plus AGS-8M4
- description
- Women with platinum resistent ovarian cancer
- interventionNames
- Biological: AGS-8M4
- Drug: Pegylated liposomal doxorubicin (PLD)
- type
- EXPERIMENTAL
- label
- B. Carboplatin and gemcitabine plus AGS-8M4
- description
- Women with platinum sensitive ovarian cancer
- interventionNames
- Biological: AGS-8M4
- Drug: gemcitabine
- Drug: carboplatin
Primary outcomes (1)
- measure
- Incidence of adverse events
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Subjects with recurrent disease Stage III/IV diagnosis of epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal carcinoma * Subjects with either platinum resistant or platinum sensitive ovarian cancer * At least 14 days of previous cytotoxic chemotherapy and have recovered from all toxicities * Left ventricular ejection fraction (LVEF) equal to or greater than the institutional lower limit of normal as measured by echocardiogram or MUGA (ONLY required for platinum resistant patients) Exclusion Criteria: * Active infection requiring treatment with systemic (intravenous or oral) anti-infectives (antibiotic, antifungal, or antiviral agent) within 72 hours of screening * Use of any investigational drug within 30 days prior to screening * Prior monoclonal antibody therapy other than Avastin * Avastin administration within 90 days of screening * History of thromboembolic events and bleeding disorders ≤ 3 months (e.g.,DVT or PE)
References
Publications (0)
Data not yet available