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Safety Study of BJ-001, an IL-15 Fusion Protein, for Locally Advanced/Metastatic Solid Tumors

NCT04294576 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 92

Last updated 2023-11-09

No results posted yet for this study

Summary

The purpose of this study is to assess the safety and tolerability of BJ-001, a human IL-15 fusion protein, administered via subcutaneous injections, as a single agent and in combination with pembrolizumab in adult patients with Locally Advanced/Metastatic Solid Tumors

Conditions

  • Locally Advanced/Metastatic Solid Tumors

Interventions

DRUG

BJ-001

BJ-001 dosed via SC injection as single agent. One cycle is 6 weeks.

DRUG

Pembrolizumab

BJ-001 dosed via SC injection in combination with Pembrolizumab One cycle is 6 weeks.

Sponsors & Collaborators

  • PPD Development, LP

    collaborator INDUSTRY

  • Merck Sharp & Dohme LLC

    collaborator INDUSTRY

  • BJ Bioscience, Inc.

    lead INDUSTRY

Principal Investigators

  • Joe Zhang, PhD · BJ Bioscience

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-12-04
Primary Completion
2024-04-29
Completion
2024-10-22
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04294576 on ClinicalTrials.gov