Status:
UNKNOWN
Phase 1 First-in-human Study of JS014
Lead Sponsor:
Anwita Biosciences
Collaborating Sponsors:
Shanghai Junshi Bioscience Co., Ltd.
Conditions:
Neoplasm Malignant
Neoplasm, Experimental
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 pembrolizuma...
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 p...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 28 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2025
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT05296772
Start Date
February 28 2022
End Date
January 1 2025
Last Update
September 6 2023
Active Locations (2)
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1
Taipei Medical University -Shuang Ho Hospital
New Taipei City, Taiwan
2
Wanfang Hospital -Taipei Medical University
Taipei, Taiwan, 106