Expanded Access Study of TJ004309 in Patients With Advanced or Metastatic Cancer
Primary Purpose
Cancer
Status
No longer available
Phase
Locations
United States
Study Type
Expanded Access
Intervention
TJ004309
Atezolizumab
Sponsored by
About this trial
This is an expanded access trial for Cancer
Eligibility Criteria
Inclusion Criteria:
- Participation in the Tracon sponsored 4309ST101 study and thought to have potential to derive clinical benefit from continued treatment in the opinion of the parent study investigator from uninterrupted dosing of TJ004309 in combination with atezolizumab.
- Willing or able to comply with study treatment and standard of care testing and procedures.
Exclusion Criteria:
- 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.
Sites / Locations
- University of Alabama at Birmingham
- HonorHealth Research Institute
- Arizona Oncology Associates, P.C.
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT04869501
First Posted
April 28, 2021
Last Updated
April 27, 2023
Sponsor
I-Mab Biopharma US Limited
1. Study Identification
Unique Protocol Identification Number
NCT04869501
Brief Title
Expanded Access Study of TJ004309 in Patients With Advanced or Metastatic Cancer
Official Title
Expanded Access Protocol for an Intermediate Size Population-use of TJ004309 in Combination With Atezolizumab (Tecentriq®) in Patients With Advanced or Metastatic Cancer
Study Type
Expanded Access
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
No longer available
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
I-Mab Biopharma US Limited
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer
7. Study Design
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
TJ004309
Intervention Description
Antibody to CD73
Intervention Type
Drug
Intervention Name(s)
Atezolizumab
Other Intervention Name(s)
Tecentriq
Intervention Description
Humanized monoclonal antibody to PD-L1
10. Eligibility
Sex
All
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
HonorHealth Research Institute
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85258
Country
United States
Facility Name
Arizona Oncology Associates, P.C.
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85704
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Expanded Access Study of TJ004309 in Patients With Advanced or Metastatic Cancer
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