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Phase 1 First-in-human Study of JS014

NCT05296772 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2023-09-06

No results posted yet for this study

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.

Conditions

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

Interventions

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

Sponsors & Collaborators

  • Shanghai Junshi Bioscience Co., Ltd.

    collaborator OTHER

  • Anwita Biosciences

    lead INDUSTRY

Principal Investigators

  • TJ Chiou, MD · Wanfang Hospital-Taipei Medical University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-28
Primary Completion
2024-06-30
Completion
2025-01-31
FDA Drug
Yes

Countries

  • Taiwan

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05296772 on ClinicalTrials.gov