NCT05296772

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 pembrolizumab in subjects with advanced cancer.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Feb 2022

Typical duration for phase_1

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 28, 2022

Completed
Same day until next milestone

Study Start

First participant enrolled

February 28, 2022

Completed
25 days until next milestone

First Posted

Study publicly available on registry

March 25, 2022

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2025

Completed
Last Updated

September 6, 2023

Status Verified

September 1, 2023

Enrollment Period

2.3 years

First QC Date

February 28, 2022

Last Update Submit

September 3, 2023

Conditions

Neoplasm MalignantNeoplasm, ExperimentalSolid Tumor, AdultLymphoma

Keywords

phase 1JS014first-in-human

Outcome Measures

Primary Outcomes (3)

  • The numbers of participants with treatment-related adverse events assessed by CTCAE 5.0

    To determine the percentage of various toxicities assessed by CTCAE at different dose levels alone or in combination with pembrolizumab

    24 months

  • Maximum tolerated dose (MTD) of JS014

    To determine the MTD of JS014 alone or in combination with pembrolizumab

    24 months

  • Recommended phase-2 dose (RP2D) of JS014

    To determine of the RP2D of JS014 alone or in combination of pembrolizumab

    24 months

Secondary Outcomes (10)

  • Area under the curve (AUC) of JS014

    24 months

  • Maximum concentration (Cmax) of JS014

    24 months

  • Clearance of JS014

    24 months

  • Half life (T1/2) of JS014

    24 months

  • Volume of distribution (Vd) of JS014

    24 months

  • +5 more secondary outcomes

Study Arms (1)

Dose escalation

OTHER

A open-label single arm of JS014 alone or in combination with pembrolizumab

Biological: JS014, Interleukin 21 and humanized anti-human serum albumin VHH antibodyBiological: Pembrolizumab - anti-PD-1 antibody

Interventions

JS014, Interleukin 21 and humanized anti-human serum albumin VHH antibodyBIOLOGICAL

Weekly infusion at the designated dose level until disease progression, withdrawal or up to two years

Dose escalation
Pembrolizumab - anti-PD-1 antibodyBIOLOGICAL

200 mg, once every three weeks until disease progression, withdrawal or up to two years

Also known as: Keytruda
Dose escalation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Taipei Medical University -Shuang Ho Hospital

New Taipei City, Taiwan

RECRUITING

Wanfang Hospital -Taipei Medical University

Taipei, 106, Taiwan

RECRUITING

MeSH Terms

Conditions

NeoplasmsNeoplasms, ExperimentalLymphoma

Interventions

Interleukin-21pembrolizumab

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

InterleukinsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological Factors

Study Officials

  • TJ Chiou, MD

    Wanfang Hospital-Taipei Medical University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

E Liu, MD

CONTACT

(650)660-9828eliu@anwitabio.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Model Details: Single group assignment
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 28, 2022

First Posted

March 25, 2022

Study Start

February 28, 2022

Primary Completion

June 1, 2024

Study Completion

January 1, 2025

Last Updated

September 6, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

TW(2)