Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as TJ004309
Uliledlimab · 4 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 |
|---|---|---|
| Group A | EXPERIMENTAL | Non-squamous Squamous |
| Group B | EXPERIMENTAL | Non-squamous Squamous |
| Group C | SHAM_COMPARATOR | - |
| 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 |
|---|---|---|
| Uliledlimab | DRUG | 30 mg/kg, administered on Days 1 and 8 of Cycle 1 (C1D1 and C1D8), then once every 3 weeks (Q3W) starting from C2D1,at most 35 cycles |
| Sintilimab | DRUG | Intravenous infusion at a recommended dose of 200 mg once every 3 weeks，at most 35 cycles |
| Pemetrexed | DRUG | Intravenously at a recommended dose of 500 mg/m2 body surface area (BSA) ,once every 3 weeks until the disease progresses. |
| Gemcitabine | DRUG | 1000 mg/m2, administered on Days 1 and 8 ,once every 3 weeks (Q3W) for 4 cycles |
| Cisplatin Or Carboplatin | DRUG | Cisplatin: 5 mg/m2 administered intravenously every 3-4 weeks for 4 cycles Carboplatin:75 mg/m2, administered intravenously every 3-4 weeks for 4 cycles |
| Toripalimab | DRUG | 240 mg on Day 1, once every 3 weeks (Q3W) |
| Pembrolizumab | DRUG | 200 mg on Day 1, once every 3 weeks (Q3W) |
| TJ004309 | DRUG | Antibody to CD73 |
Inclusion Criteria: 1. Patients aged ≥ 18 years at the time of signing the ICF. 2. Patients with histologically or cytologically confirmed stage IIIB, IIIC, or IV NSCLC who are not suitable for radical surgery and/or radiotherapy. 3. Patients who have not received prior systemic therapy for their l...
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Uliledlimab is an investigational monoclonal antibody being studied in oncology for advanced solid tumors, non-small cell lung cancer, and ovarian cancer. It is being developed for use in combination with other therapies, including sintilimab, toripalimab, atezolizumab, and chemotherapy, in patients with locally advanced unresectable or metastatic disease.
Uliledlimab is being developed by NovaBridge Biosciences, which trades under the ticker NBP. The company is the sponsor of the clinical trials evaluating uliledlimab in solid tumors and non-small cell lung cancer.
Uliledlimab is in Phase 1 and Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA. The Phase 1 study in advanced solid tumors has been completed, and two Phase 2 trials in non-small cell lung cancer are currently active but not recruiting.
Uliledlimab has been evaluated in four clinical trials. NCT07005336 and NCT06984588 are active Phase 2 trials in non-small cell lung cancer in China. NCT05001347 was a completed Phase 2 trial in ovarian cancer and selected solid tumors in the United States. NCT04322006 was a completed Phase 1/2 trial in advanced solid tumors in China.
Yes, Uliledlimab is also known as TJ004309. Both names refer to the same investigational monoclonal antibody developed by NovaBridge Biosciences. The alternative name TJ004309 appears in earlier clinical trial records, including NCT05001347 and NCT04322006.