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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
I-Mab Biopharma US Limited
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an expanded access trial for Cancer

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All Sexes

Inclusion Criteria:

  1. 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.
  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.

Sites / Locations

  • University of Alabama at Birmingham
  • HonorHealth Research Institute
  • Arizona Oncology Associates, P.C.

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
April 28, 2021
Last Updated
April 27, 2023
Sponsor
I-Mab Biopharma US Limited
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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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