Patiens with locally advanced/metastatic endometrial carcinoma or cervix carcinoma progressing/relapsing after at least one prior systemic chemotherapy.
Conditions
Brief summary
Phase II part: Overall response Rate (ORR) after 3 months (ORR3m) is defined as the rate of patients with CR or PR. Response will be evaluated as per RECIST 1.1 (Eisenhauer et al., 2009) by BICR after 3 months of treatment.
Detailed description
Part II part, both part safety endpoints: Safety will be assessed by the following assessments: adverse events (AEs), vital signs, ECG, physical examination, laboratory safety assessments (hematological and biochemical parameters). All AEs will be graded according to NCI-CTCAE V5.0. In case of Infusion Related Reaction, blood samples will be collected to monitor the PK profile and Immunogenicity using ADA for NP137 assays., Phase II part, both part efficacy endpoints: Objective response Rate (ORR) after 3 months of treatment will be also assessed as per modified criteria for immunotherapies iRECIST. Overall objective response Rate beyond 3 months of treatment will be assessed as per RECIST V1.1 and iRECIST (assessment by both BICR and investigator). Duration of Response (DoR). *Best Overall Response Rate. *Clinical Benefit Rate (CBR). *Progression-free survival (PFS). *Overall survival (OS), Pharmacokinetic endpoints: The following PK parameters will be determined for NP137 treated patients during the safety run in period only: Cmax, tmax, AUCt, AUC, CL, t½ based on both individual PK and popPK models.
Interventions
Sponsors
Netris Pharma
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phase II part: Overall response Rate (ORR) after 3 months (ORR3m) is defined as the rate of patients with CR or PR. Response will be evaluated as per RECIST 1.1 (Eisenhauer et al., 2009) by BICR after 3 months of treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Part II part, both part safety endpoints: Safety will be assessed by the following assessments: adverse events (AEs), vital signs, ECG, physical examination, laboratory safety assessments (hematological and biochemical parameters). All AEs will be graded according to NCI-CTCAE V5.0. In case of Infusion Related Reaction, blood samples will be collected to monitor the PK profile and Immunogenicity using ADA for NP137 assays., Phase II part, both part efficacy endpoints: Objective response Rate (ORR) after 3 months of treatment will be also assessed as per modified criteria for immunotherapies iRECIST. Overall objective response Rate beyond 3 months of treatment will be assessed as per RECIST V1.1 and iRECIST (assessment by both BICR and investigator). Duration of Response (DoR). *Best Overall Response Rate. *Clinical Benefit Rate (CBR). *Progression-free survival (PFS). *Overall survival (OS), Pharmacokinetic endpoints: The following PK parameters will be determined for NP137 t | — |
Countries
France
Outcome results
None listed