Phase 1 First-in-human Study of JS014

Launched by ANWITA BIOSCIENCES · Mar 16, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called JS014 to see if it is safe and effective for patients with advanced cancers, including solid tumors and lymphoma. It is a phase 1 trial, which means it is the first time this treatment is being tested in humans. Researchers will look at different doses of JS014, both on its own and in combination with another drug called pembrolizumab, to find the best approach for patients who have no other treatment options available.

To be eligible for this trial, participants must be at least 18 years old and have advanced cancer or lymphoma. They should have a life expectancy of more than three months and be in decent health, with specific functions of their organs working well. However, individuals with certain health conditions, like recent surgery, severe autoimmune diseases, or active infections, may not be able to participate. If someone joins the study, they can expect close monitoring during the trial, as safety is a top priority. This is an important step in exploring new cancer treatments that may help improve outcomes for patients who have limited options.

Gender

ALL

Eligibility 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.