Glioblastoma
Conditions
Brief summary
For Phase I the following primary safety endpoints will be considered: − Occurrence of dose limiting toxicity (DLT) assessed by frequency and grade of adverse events (AE) according to CTCAE v.5.0., For Phase II the following primary endpoint will be considered: − Overall survival (OS) rate at 12 months (52 weeks)., For Phase IIb the following primary endpoint will be considered: − Overall survival (OS)
Detailed description
For Phase I the following secondary safety endpoints will be considered: − Assessment of the formation of human anti-fusion protein antibodies (HAFA) against L19TNF. − Pharmacokinetic characterization of L19TNF. The following secondary efficacy endpoints will be considered: − Progression-free survival (PFS) based on iRANO criteria and a standardized MRI protocol. − Overall survival (OS) rate at 12 months (52 weeks). − OS. − Objective Response Rate (ORR, consisting of complete, For Phase II the following secondary efficacy endpoints will be considered: − PFS based on iRANO criteria and a standardized MRI protocol. − OS − ORR (consisting of CR and PR) at Week 10, at Week 22, at Week 34, at Week 46 and at Week 58 − BORR The following secondary safety endpoints will be considered: − Frequency and grade of AEs, SAE and DILI according to CTCAE v.5.0 − Assessment of the formation of HAFA against L19TNF − Pharmacokinetic characterization of L19TNF, For Phase IIb The following secondary efficacy endpoints will be considered: − PFS based on iRANO criteria based on standardized MRI protocol. − OS rate at 12 months (52 weeks) − ORR and DCR at Week 10, at Week 22, at Week 34, at Week 46 and at Week 58 − BORR The following secondary safety endpoint will be considered: − Frequency and grade of AEs, SAEs and DILI according to CTCAE v.5.0. − Assessment of the formation of HAFA against L19TNF. − PK characterization of L19TNF.
Interventions
Sponsors
Philogen S.p.A.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| For Phase I the following primary safety endpoints will be considered: − Occurrence of dose limiting toxicity (DLT) assessed by frequency and grade of adverse events (AE) according to CTCAE v.5.0., For Phase II the following primary endpoint will be considered: − Overall survival (OS) rate at 12 months (52 weeks)., For Phase IIb the following primary endpoint will be considered: − Overall survival (OS) | — |
Secondary
| Measure | Time frame |
|---|---|
| For Phase I the following secondary safety endpoints will be considered: − Assessment of the formation of human anti-fusion protein antibodies (HAFA) against L19TNF. − Pharmacokinetic characterization of L19TNF. The following secondary efficacy endpoints will be considered: − Progression-free survival (PFS) based on iRANO criteria and a standardized MRI protocol. − Overall survival (OS) rate at 12 months (52 weeks). − OS. − Objective Response Rate (ORR, consisting of complete, For Phase II the following secondary efficacy endpoints will be considered: − PFS based on iRANO criteria and a standardized MRI protocol. − OS − ORR (consisting of CR and PR) at Week 10, at Week 22, at Week 34, at Week 46 and at Week 58 − BORR The following secondary safety endpoints will be considered: − Frequency and grade of AEs, SAE and DILI according to CTCAE v.5.0 − Assessment of the formation of HAFA against L19TNF − Pharmacokinetic characterization of L19TNF, For Phase IIb The following secondary efficac | — |
Countries
Germany, Italy
Outcome results
None listed