First-in-human assessment of JS014 for advanced cancer treatment
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 study is testing a new treatment called JS014, both alone and with another drug, to see if it can help people with advanced cancer or lymphoma feel better and improve their condition.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Anwita Biosciences Industry-sponsored |
| Drugs / interventions | pembrolizumab, immunotherapy |
| Locations | 2 sites (New Taipei City and 1 other locations) |
| Trial ID | NCT05296772 on ClinicalTrials.gov |
What this trial studies
This phase 1 study evaluates the safety and potential efficacy of JS014, both as a single agent and in combination with pembrolizumab, in patients with advanced cancer or lymphoma. The study is divided into two parts: Part Ia focuses on JS014 alone, while Part Ib examines the combination with pembrolizumab. Eligible participants will undergo screening and receive weekly infusions of JS014 until disease progression, with regular assessments of safety and efficacy. The study aims to determine the appropriate dosing and safety profile of JS014 in this patient population.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 with advanced cancer or lymphoma who are ineligible for standard therapies or unwilling to undergo cytotoxic treatments.
Not a fit: Patients with known allergies to JS014, IL-21, or pembrolizumab, or those with recent major surgeries or significant immune-related adverse events may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new treatment option for patients with advanced cancers who have limited or no available therapies.
How similar studies have performed: Other studies have shown promise with similar immunotherapy approaches, but this specific combination is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Older 18 years of age or per local regulation * Subjects with advanced cancer or lymphoma who have no standard therapy available, ineligible for standard therapy or unwilling to receive cytotoxic therapy . * ECOG PS 0-1 * A life expectancy longer than three months * Adequate organ functions * Able to adopt effective contraceptive measures Exclusion Criteria: * Known history of allergies to JS014 or IL-21 or human serum albumin or pembrolizumab (Ib only) * Subjects who have received major surgery less than 4 weeks before 1st infusion of JS014 * Subjects who has a history of immune-related adverse events in prior immunotherapy. * Subjects who have received immunosuppressive therapy less than 4 weeks before 1st infusion of JS014. * Subjects who have two or more primary cancers in the past 5 years. * Newly diagnosed or symptomatic brain metastases. * Subjects who have received prior anti-cancer therapy with residual toxicities greater than grade 2. * Subjects who have a history of autoimmune disease in 2 years. * Subjects who have active infection, or uncontrollable hypertension, unstable angina, active peptic ulcer, recent acute myocardial infarction, severe congestive heart failure, or unhealed wound. * Subjects with active hepatitis B or hepatitis C. * Subjects who are pregnant or breast feeding. * Subjects who primary immune deficiency.
Where this trial is running
New Taipei City and 1 other locations
- Taipei Medical University -Shuang Ho Hospital — New Taipei City, Taiwan (Recruiting)
- Wanfang Hospital -Taipei Medical University — Taipei, Taiwan (Recruiting)
Study contacts
- Principal investigator: TJ Chiou, MD — Wanfang Hospital-Taipei Medical University
- Study coordinator: E Liu, MD
- Email: eliu@anwitabio.com
- Phone: (650)660-9828
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.