Expanded Access Study of TJ004309 in Patients With Advanced or Metastatic Cancer
Expanded Access Protocol for an Intermediate Size Population-use of TJ004309 in Combination With Atezolizumab (Tecentriq®) in Patients With Advanced or Metastatic Cancer
1 other identifier
expanded_access
N/A
1 country
3
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 28, 2021
CompletedFirst Posted
Study publicly available on registry
May 3, 2021
CompletedApril 28, 2023
April 1, 2023
April 28, 2021
April 27, 2023
Conditions
Interventions
Antibody to CD73
Eligibility Criteria
You may qualify if:
- 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.
- Willing or able to comply with study treatment and standard of care testing and procedures.
You may not qualify if:
- Any unresolved ongoing toxicity or clinical event that would make continued treatment with TJ004309 inappropriate.
- Current treatment in another clinical study or treatment with other standard of care therapy.
- Currently pregnant.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
HonorHealth Research Institute
Scottsdale, Arizona, 85258, United States
Arizona Oncology Associates, P.C.
Tucson, Arizona, 85704, United States
MeSH Terms
Conditions
Interventions
Study Design
- Study Type
- expanded access
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 28, 2021
First Posted
May 3, 2021
Last Updated
April 28, 2023
Record last verified: 2023-04