Recurrent endometrial cancer, recurrent epithelial ovarian, fallopian tube, and primary peritoneal cancer (EOC), recurrent cervical cancer
Conditions
Brief summary
Co-Primary Endpoints: Incidence of adverse events (AEs), serious adverse events (SAEs), and DLTs; Determine the recommended dose of IMGN151 monotherapy
Detailed description
Summary PK parameters and treatment-emergent anti-drug antibodies (ADAs), ORR (which includes best response of complete response [CR] or partial response [PR] as assessed by the investigator) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria, DOR (defined as the time from initial response [CR or PR] until radiological progressive disease [PD], as assessed by the investigator, or death, whichever occurs first) per RECIST v1.1 criteria
Interventions
Sponsors
AbbVie Deutschland GmbH & Co. KG
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Co-Primary Endpoints: Incidence of adverse events (AEs), serious adverse events (SAEs), and DLTs; Determine the recommended dose of IMGN151 monotherapy | — |
Secondary
| Measure | Time frame |
|---|---|
| Summary PK parameters and treatment-emergent anti-drug antibodies (ADAs), ORR (which includes best response of complete response [CR] or partial response [PR] as assessed by the investigator) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria, DOR (defined as the time from initial response [CR or PR] until radiological progressive disease [PD], as assessed by the investigator, or death, whichever occurs first) per RECIST v1.1 criteria | — |
Countries
Belgium, France, Germany, Ireland, Italy, Netherlands, Spain
Outcome results
None listed