Phase 1 First-in-human Study of JS014

Anwita Biosciences

Status and phase

Enrolling

Phase 1

Conditions

Solid Tumor, Adult

Neoplasm, Experimental

Lymphoma

Neoplasm Malignant

Treatments

Biological: Pembrolizumab - anti-PD-1 antibody

Biological: JS014, Interleukin 21 and humanized anti-human serum albumin VHH antibody

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT05296772

AWT-EXK21-001

Details and patient eligibility

About

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.

Full 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.

Enrollment

60 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.