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A Phase 1 Study of JS014, a Recombinant Fusion Protein of Interleukin-21 and Humanized Anti-human Serum Albumin VHH Antibody as a Single Agent or in Combination With Pembrolizumab in Subjects With Advanced Cancer
This phase 1, first-in-human study uses a BOIN design to assess the safety and potential efficacy of JS014 at different dose levels as a single agent and in combination with fixed dose of pembrolizumab in subjects with advanced cancer.
Details
| Lead sponsor | Anwita Biosciences |
|---|---|
| Phase | Phase 1 |
| Status | UNKNOWN |
| Enrolment | 60 |
| Start date | 2022-02-28 |
| Completion | 2025-01 |
Conditions
- Neoplasm Malignant
- Neoplasm, Experimental
- Solid Tumor, Adult
- Lymphoma
Interventions
- JS014, Interleukin 21 and humanized anti-human serum albumin VHH antibody
- Pembrolizumab - anti-PD-1 antibody
Primary outcomes
- The numbers of participants with treatment-related adverse events assessed by CTCAE 5.0 — 24 months
To determine the percentage of various toxicities assessed by CTCAE at different dose levels alone or in combination with pembrolizumab - Maximum tolerated dose (MTD) of JS014 — 24 months
To determine the MTD of JS014 alone or in combination with pembrolizumab - Recommended phase-2 dose (RP2D) of JS014 — 24 months
To determine of the RP2D of JS014 alone or in combination of pembrolizumab
Countries
Taiwan