Solid tumors in 4 tumor types: platinum resistant ovarian cancer, triple-negative breast cancer (TNBC), endometrial cancer (EC), and non-small cell lung cancer adenocarcinoma; NSCLC).
Conditions
Brief summary
RP2D of MORAb-202 (Dose-Escalation Part only).For Dose Optimization Part B: RD of MORAb-202 IV monotherapy and in combination with Lenvatinib., ORR: defined as the proportion of subjects achieving a best overall response (BOR) of complete response (CR) or partial response (PR) (BOR - are CR, PR, SD, PD, and not evaluable (NE), where SD has to be achieved at ≥5 weeks after the first dose. All responses of CR and PR must be confirmed no less than 28 days following the initial achievement of the response., Safety Endpoints: DLTs, AEs,(SAEs, AEs leading to treatment discontinuation),AEs leading to dose interruption/reduction and AEIs (including ILD incidence, severity, duration and outcome, and deaths).
Detailed description
DOR, DCR, CBR, PFS by RECIST 1.1, and OS. Safety Endpoints: clinical laboratory tests, vital signs, oxygen saturation, body weight, 12-lead ECGs, ECOG PS, and The PK profiles of MORAb-202/total antibody/released eribulin in serum or plasma. The relationship between FRA expression levels in tumor tissue and clinical outcome.
Interventions
Sponsors
Eisai Limited
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| RP2D of MORAb-202 (Dose-Escalation Part only).For Dose Optimization Part B: RD of MORAb-202 IV monotherapy and in combination with Lenvatinib., ORR: defined as the proportion of subjects achieving a best overall response (BOR) of complete response (CR) or partial response (PR) (BOR - are CR, PR, SD, PD, and not evaluable (NE), where SD has to be achieved at ≥5 weeks after the first dose. All responses of CR and PR must be confirmed no less than 28 days following the initial achievement of the response., Safety Endpoints: DLTs, AEs,(SAEs, AEs leading to treatment discontinuation),AEs leading to dose interruption/reduction and AEIs (including ILD incidence, severity, duration and outcome, and deaths). | — |
Secondary
| Measure | Time frame |
|---|---|
| DOR, DCR, CBR, PFS by RECIST 1.1, and OS. Safety Endpoints: clinical laboratory tests, vital signs, oxygen saturation, body weight, 12-lead ECGs, ECOG PS, and The PK profiles of MORAb-202/total antibody/released eribulin in serum or plasma. The relationship between FRA expression levels in tumor tissue and clinical outcome. | — |
Countries
France, Spain
Outcome results
None listed