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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04869501
Expanded Access Status : No longer available
First Posted : May 3, 2021
Last Update Posted : May 3, 2021
Sponsor:
Information provided by (Responsible Party):
I-Mab Biopharma Co. Ltd.

Study Description
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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.

Condition or disease Intervention/treatment
Cancer Drug: TJ004309 Drug: Atezolizumab

Study Design
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Study Type : Expanded Access
Expanded Access Type : Intermediate-size Population
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

Resource links provided by the National Library of Medicine


Interventions
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Intervention Details:
  • Drug: TJ004309
    Antibody to CD73
  • Drug: Atezolizumab
    Humanized monoclonal antibody to PD-L1
    Other Name: Tecentriq
Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04869501


Locations
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United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
United States, Arizona
HonorHealth Research Institute
Scottsdale, Arizona, United States, 85258
Sponsors and Collaborators
I-Mab Biopharma Co. Ltd.
More Information
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Responsible Party: I-Mab Biopharma Co. Ltd.
ClinicalTrials.gov Identifier: NCT04869501    
Other Study ID Numbers: TJ004309STM104
First Posted: May 3, 2021    Key Record Dates
Last Update Posted: May 3, 2021
Last Verified: April 2021
Additional relevant MeSH terms:
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Neoplasm Metastasis
Neoplastic Processes
Neoplasms
 Pathologic Processes
Atezolizumab
Antineoplastic Agents