Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
TJ011133 · 1 trial · 2 indications
Part 1A DLT period is 3 weeks, Part 1B DLT period is 3 weeks, Part 1C DLT period is 4 weeks.
The CTCAE criteria will be used to assess adverse events on this trial.
Based on DLT definitions.
Change in Eastern Cooperative Oncology Group (ECOG) Performance Status.
| Arm | Type | Description |
|---|---|---|
| Part 1A - TJ011133 Monotherapy | EXPERIMENTAL | TJ011133 alone will be administered at up to 7 dose levels (0.3, 1, 3, 10, 20, 30, 45 mg/kg) once weekly (Q1W) (the 0.3 mg/kg dose level cohort will be enrolled if a DLT in 1 out of 3 subjects is observed following the 1 mg/kg dose level). |
| Part 1B - Combination therapy of TJ011133 with pembrolizumab | EXPERIMENTAL | TJ011133 will be administered Q1W, starting at 20 mg/ kg, in combination with pembrolizumab. |
| Part 1C - Combination therapy of TJ011133 with rituximab | EXPERIMENTAL | TJ011133 will be administered Q1W, starting at 20 mg/kg, in combination with rituximab. |
| Part 2 - Dose Expansion | EXPERIMENTAL | 30 participants (with DLBCL or indolent lymphoma) in the TJ011133 combination therapy with rituximab expansion and 20 participants with solid tumors in the TJ011133 combination therapy with pembrolizumab expansion. |
| Name | Type | Description |
|---|---|---|
| TJ011133 | DRUG | TJ011133 will be administered weekly. |
| Pembrolizumab | DRUG | Pembrolizumab will be administered every 3 weeks. |
| Rituximab | DRUG | Rituximab will be administered weekly for 5 doses, then followed by monthly doses. |
Inclusion Criteria: * Part 1: Participants with advanced relapsed/refractory solid tumors and lymphoma. * Part 2 with Rituximab: Participants with diffuse large B-cell lymphoma (DLBCL) or Indolent B-cell Lymphoma, with at least one measurable lesion by Lugano and available fresh metastatic biopsy s...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Merck & Co., Inc. | MRK | 3 | PHASE2 | Pembrolizumab, Gardasil 9 |
| Incyte Corporation | INCY | 1 | PHASE2 | Retifanlimab |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE1 | KFA115 |
| Iovance Biotherapeutics Inc | IOVA | 2 | PHASE2 | Aldesleukin |
| AstraZeneca PLC | AZN | 1 | - | Trastuzumab deruxtecan |
TJ011133 is an investigational small molecule being studied for the treatment of advanced solid tumors and lymphoma. It is being developed by NovaBridge Biosciences for patients with relapsed or refractory disease, meaning cancers that have returned or not responded to prior therapy. It has not been approved for any indication.
TJ011133 targets CD47, a protein often overexpressed on cancer cells that helps them evade immune detection. By binding CD47, TJ011133 is designed to block the "don't eat me" signal and enable macrophages to recognize and destroy tumor cells. CD47 is a protein target.
TJ011133 is being developed by NovaBridge Biosciences, which trades under the ticker NBP. The company is the sponsor of the clinical program evaluating this small molecule in oncology.
TJ011133 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA or any other regulatory agency. The Phase 1 program has been completed, with one trial conducted to evaluate the drug in patients with advanced solid tumors and lymphoma.
TJ011133 has been evaluated in one completed Phase 1 trial, NCT03934814, titled "Study of TJ011133 in Participants With Relapsed/Refractory Advanced Solid Tumors and Lymphoma." The trial enrolled 98 participants across the United States and China and included a controlled design.