Advanced Malignancies Associated with EphA2 Expression
Conditions
Brief summary
1. Treatment-emergent adverse events (TEAEs), laboratory, ECG and vital sign abnormalities using CTCAE v5.0 criteria., 2. Dose-limiting toxicities as defined in the protocol., 3. Objective response rate (ORR [CR + PR]), duration of response (DOR), clinical benefit rate (CR + PR + SD ≥4 months), time to tumor progression (TTP), progression-free survival time (PFS), rate of PFS at 6 mos., all assessed per RECIST v1.1 criteria as assessed by the Investigator, and OS.
Detailed description
1. Objective response rate (ORR), duration of response (DOR), clinical benefit rate (CR + PR + SD ≥4 months), time to tumor progression (TTP), progression-free survival time (PFS), rate of PFS at 6 mos., all assessed per RECIST v1.1 criteria, and OS, 2. Treatment-emergent adverse events (TEAEs), laboratory, ECG and vital sign abnormalities using CTCAE v5.0 criteria, 3. Objective response rate (ORR), duration of response (DOR), clinical benefit rate (CR + PR + SD ≥4 months), time to tumor progression (TTP), progression-free survival time (PFS), rate of PFS at 6 mos., all assessed per RECIST v1.1 criteria, per EphA2 expression, and OS., 4. Plasma concentrations of BT5528 and MMAE with appropriate pharmacokinetic derivations such as Cmax, Cmin, AUC, and elimination t½, 5. Measurement of ADA.
Interventions
DRUGNIVOLUMAB
DRUGBT5528
Sponsors
Bicycletx Limited
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Treatment-emergent adverse events (TEAEs), laboratory, ECG and vital sign abnormalities using CTCAE v5.0 criteria., 2. Dose-limiting toxicities as defined in the protocol., 3. Objective response rate (ORR [CR + PR]), duration of response (DOR), clinical benefit rate (CR + PR + SD ≥4 months), time to tumor progression (TTP), progression-free survival time (PFS), rate of PFS at 6 mos., all assessed per RECIST v1.1 criteria as assessed by the Investigator, and OS. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Objective response rate (ORR), duration of response (DOR), clinical benefit rate (CR + PR + SD ≥4 months), time to tumor progression (TTP), progression-free survival time (PFS), rate of PFS at 6 mos., all assessed per RECIST v1.1 criteria, and OS, 2. Treatment-emergent adverse events (TEAEs), laboratory, ECG and vital sign abnormalities using CTCAE v5.0 criteria, 3. Objective response rate (ORR), duration of response (DOR), clinical benefit rate (CR + PR + SD ≥4 months), time to tumor progression (TTP), progression-free survival time (PFS), rate of PFS at 6 mos., all assessed per RECIST v1.1 criteria, per EphA2 expression, and OS., 4. Plasma concentrations of BT5528 and MMAE with appropriate pharmacokinetic derivations such as Cmax, Cmin, AUC, and elimination t½, 5. Measurement of ADA. | — |
Countries
Belgium, Spain
Outcome results
None listed