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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

Status
NO_LONGER_AVAILABLE
Phases
Unknown
Study type
Expanded Access
Source
ClinicalTrials.gov
Registry ID
NCT04869501
Enrollment
Unknown
Registered
2021-05-03
Start date
Unknown
Completion date
Unknown
Last updated
2023-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer

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.

Interventions

DRUGTJ004309

Antibody to CD73

DRUGAtezolizumab

Humanized monoclonal antibody to PD-L1

Sponsors

I-Mab Biopharma US Limited
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
ALL

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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026