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

NCT ID: NCT04869501

Last Updated: 2023-04-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NO_LONGER_AVAILABLE

Study Classification

EXPANDED_ACCESS

Brief Summary

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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.

Detailed Description

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Conditions

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Cancer

Interventions

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TJ004309

Antibody to CD73

Intervention Type DRUG

Atezolizumab

Humanized monoclonal antibody to PD-L1

Intervention Type DRUG

Other Intervention Names

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Tecentriq

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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I-Mab Biopharma US Limited

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status

HonorHealth Research Institute

Scottsdale, Arizona, United States

Site Status

Arizona Oncology Associates, P.C.

Tucson, Arizona, United States

Site Status

Countries

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United States

Other Identifiers

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TJ004309STM104

Identifier Type: -

Identifier Source: org_study_id

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