Expanded Access Study of TJ004309 in Patients With Advanced or Metastatic Cancer

April 27, 2023 updated by: I-Mab Biopharma US Limited

Expanded Access Protocol for an Intermediate Size Population-use of TJ004309 in Combination With Atezolizumab (Tecentriq®) in Patients With Advanced or Metastatic Cancer

This expanded access protocol was designed to provide TJ004309 in combination with atezolizumab to the remaining three patients with advanced or metastatic cancer who plan to continue with treatment.

Study Overview

Status

No longer available

Conditions

Intervention / Treatment

Study Type

Expanded Access

Expanded Access Type

  • Intermediate-size Population

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • University of Alabama at Birmingham
    • Arizona
      • Scottsdale, Arizona, United States, 85258
        • HonorHealth Research Institute
      • Tucson, Arizona, United States, 85704
        • Arizona Oncology Associates, P.C.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Description

Inclusion Criteria:

  1. Participation in the Tracon sponsored 4309ST101 or I-Mab sponsored TJ004309STM103 study and thought to have potential to derive clinical benefit from continued treatment in the opinion of the parent study investigator from dosing of TJ004309 in combination with atezolizumab.
  2. Willing or able to comply with study treatment and standard of care testing and procedures.

Exclusion Criteria:

  1. Any unresolved ongoing toxicity or clinical event that would make continued treatment with TJ004309 inappropriate.
  2. Current treatment in another clinical study or treatment with other standard of care therapy.
  3. Currently pregnant.
  4. Current evidence of any condition (including medical, psychiatric or substance abuse disorder), therapy, or laboratory abnormality that might interfere with the patient's participation or is not in the best interest of the patient to participate, in the opinion of the treating Investigator.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

I-Mab Biopharma US Limited

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

April 28, 2021

First Submitted That Met QC Criteria

April 28, 2021

First Posted (Actual)

May 3, 2021

Study Record Updates

Last Update Posted (Actual)

April 28, 2023

Last Update Submitted That Met QC Criteria

April 27, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TJ004309STM104

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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