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A Phase I/II Study of TJ004309 for Advanced Solid Tumor

NCT04322006 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 225

Last updated 2026-05-13

No results posted yet for this study

Summary

This study is a phase I/II study of single drug TJ004309 and Toripalimab combine treatment for Advanced solid tumor. This study include two stages. First stage is dose escalation and second stage is dose extension. The purpose of part A is to confirm the MTD or MED and the clinical dose. The purpose of part B is to observe the safety, effectiveness, Pharmacokinetics, pharmacodynamics and biomarker properties for effective subjects.

Conditions

  • Advanced Solid Tumor

Interventions

DRUG

TJ004309

Antibody to CD73

DRUG

Toripalimab

Humanized monoclonal antibody to PD-1

Sponsors & Collaborators

  • TJ Biopharma Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-05-09
Primary Completion
2025-04-30
Completion
2025-04-30

Countries

  • China

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 NCT04322006 on ClinicalTrials.gov