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

I-Mab Biopharma

Status

Conditions: Cancer

Treatments: Drug: TJ004309; Drug: Atezolizumab

Study type: Expanded Access

Funder types: Industry

Identifiers

NCT04869501

TJ004309STM104

Details and patient eligibility

About

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.

Sex: All

Volunteers: No Healthy Volunteers

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.