NCT05296772

Phase 1 First-in-human Study of JS014

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

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Anwita Biosciences · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

This study has two parts: 1a and Ib. Ia is a single agent study, and Ib is a combination study, testing the safety of JS014 with 200 mg of pembrolizumab. After being informed about the study and the potential risks, all subjects giving written informed consent will receive at most 4-week screening procedures to ensure the eligibility of the study entry. Once eligible, the subjects will receive JS014 infusion at the designated dose levels once every week until disease progression. In Ia study, only JS014 is given. In Ib study, JS014 will be given once a week with pembrolizumab at 200 mg once every three weeks until disease progression. The subjects will receive safety evaluation, pharmacokinetic and pharmacodynamic studies, as well as efficacy evaluation at regular interval. The maximum number in each part of the study is 30 subjects. The Ia study will be conducted in Taiwan, and Ib study will be conducted in both Taiwan and the United States.

Conditions

• Neoplasm Malignant
• Neoplasm, Experimental
• Solid Tumor, Adult
• Lymphoma

Interventions

Type	Name	Description
BIOLOGICAL	JS014, Interleukin 21 and humanized anti-human serum albumin VHH antibody	Weekly infusion at the designated dose level until disease progression, withdrawal or up to two years
BIOLOGICAL	Pembrolizumab - anti-PD-1 antibody	200 mg, once every three weeks until disease progression, withdrawal or up to two years

Timeline

• Start date: 2022-02-28
• Primary completion: 2024-06-01
• Completion: 2025-01-01
• First posted: 2022-03-25
• Last updated: 2023-09-06

Locations

2 sites across 1 country: Taiwan

Regulatory

• FDA-regulated drug study