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A Phase I Study to Evaluate Safety and Early Signs of Efficacy of the Human Monoclonal Antibody-cytokine Fusion Protein IL12-L19L19. (DODEKA)
The purpose of this study is to describe the safety, tolerability and early signs of efficacy of the antibody-cytokine fusion protein IL12-L19L19 in patients with advanced or metastatic solid carcinomas, after previous immune checkpoint blockade therapy. The primary objective of the study is to evaluate the safety of IL12-L19L19 and to establish MTD in order to establish a recommended dose (RD). The secondary objectives of the study are to assess early signs of efficacy, the determination of pharmacokinetic (PK) properties and the immunogenicity of IL12-L19L19.
Details
| Lead sponsor | Philogen S.p.A. |
|---|---|
| Phase | Phase 1 |
| Status | RECRUITING |
| Enrolment | 80 |
| Start date | 2020-07-01 |
| Completion | 2026-12 |
Conditions
- Advanced Solid Tumor
- Metastatic Solid Tumor
Interventions
- IL12-L19L19
- IL12-L19L19
Primary outcomes
- For Part I: DLT — From Day 1 to Day 28 of the treatment
Occurrence of dose limiting toxicity (DLT) in dose escalation part of the study. - For Part I: MAD — From Day 1 to Day 28 of the treatment
Definition of Maximum Administered Dose (MAD) (in dose escalation part). The MAD is defined when at least two patients within a cohort of 2-6 patients experience a DLT (i.e., ≥33% of patients with a DLT at that dose level) - For Part I: MTD and RD — From Day 1 to Day 28 of the treatment
Defining the Maximum Tolerated Dose (MTD) and recommendation of the Recommended Dose (RD): when the DLT rate reaches 33% in a cohort, the next lower dose level will be called the MTD (so long as the DLT rate is less than 33%). Accordingly, the recommended dose (RD) for the Dose Expansion cohort will be the MTD. - Safety (AE) — Throughout study completion for each patient
Safety of administration of IL12-L19L19, through an assessed by Common Toxicity Criteria (version 5.0, CTCAE) - Safety (SAE) — Throughout study completion for each patient
Safety of administration of IL12-L19L19, assessed by Common Toxicity Criteria (version 5.0, CTCAE) - Safety (DILI) — Throughout study completion for each patient, a maximum of 24 weeks for each patient
Evaluation of possible Drug Induce Liver Injury, caused by IL12-L19L19, assessed by Common Toxicity Criteria (version 5.0, CTCAE)
Countries
Germany, Italy, Switzerland