Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
TJ004309 · 2 trials · 7 indications
Anti-tumor activity of the combination of TJ004309 and atezolizumab was measured by objective response rate (ORR) based on RECIST 1.1
The safety and tolerance of TJ004309
Maximum tolerated dose (MTD)
Maximum effective dose (MED)
| Arm | Type | Description |
|---|---|---|
| TJ004309 and Atezolizumab | EXPERIMENTAL | TJ004309 20 mg/kg Q3W in combination with atezolizumab 1200 mg Q3W |
| TJ004309 injection Monotherapy or Combination with Toripalimab | EXPERIMENTAL | TJ004309 will be dose escalated in a 3+3 design in Monotherapy or combination with Toripalimab |
| Name | Type | Description |
|---|---|---|
| TJ004309 | DRUG | Antibody to CD73 |
| Toripalimab | DRUG | Humanized monoclonal antibody to PD-1 |
Inclusion Criteria: * Cohort 1: Patients with histologically confirmed epithelial ovarian cancer, fallopian tube, or primary peritoneal cancer subjects with any high-grade serous component, progressed on or after platinum-containing therapy and not eligible for further platinum containing treatment...
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TJ004309 is an investigational small molecule being studied for the treatment of advanced solid tumors and ovarian cancer. It is also being evaluated in combination with atezolizumab (TECENTRIQ) for ovarian cancer and selected solid tumors including head and neck cancer, non-small cell lung cancer, gastrointestinal cancer, and triple negative breast cancer.
TJ004309 is being developed by I-Mab, a biopharmaceutical company. The company is listed under the ticker symbol NBP.
TJ004309 has completed Phase 1 and Phase 2 clinical trials. The Phase 1 study was for advanced solid tumors, and the Phase 2 study evaluated the drug in combination with atezolizumab for ovarian cancer and selected solid tumors. Both trials are completed.
TJ004309 has been studied in two completed clinical trials. NCT04322006 was a Phase 1 study in China for advanced solid tumors with 225 participants. NCT05001347 was a Phase 2 study in the United States combining TJ004309 with atezolizumab for ovarian cancer and selected solid tumors with 25 participants.
TJ004309 is not FDA approved. It is an investigational drug that has completed clinical trials, but approval status has not been established. The drug remains in clinical development.