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 | 2 | PHASE2 | Pembrolizumab, Gardasil 9 |
| Incyte Corporation | INCY | 1 | PHASE2 | Retifanlimab |
| Iovance Biotherapeutics Inc | IOVA | 2 | PHASE2 | Aldesleukin |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE1 | KFA115 |
| AstraZeneca PLC | AZN | 1 | - | Trastuzumab deruxtecan |
TJ011133 is an investigational small molecule being studied for the treatment of acute myeloid leukemia (AML), myelodysplastic syndromes (MDS), solid tumors, and lymphoma. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities.
TJ011133 is being developed by I-Mab, a biopharmaceutical company listed on the Nasdaq under the ticker symbol NBP. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational drug in patients with certain cancers.
TJ011133 is in Phase 1 clinical development. Two Phase 1 trials have been completed, one in patients with relapsed or refractory advanced solid tumors and lymphoma, and another in patients with acute myeloid leukemia or myelodysplastic syndromes. The drug remains investigational.
TJ011133 has been studied in two completed Phase 1 trials. NCT03934814 evaluated the drug in participants with relapsed or refractory advanced solid tumors and lymphoma, enrolling 98 participants in the United States and China. NCT04202003 evaluated it as monotherapy and in combination with azacitidine in patients with AML or MDS, enrolling 105 participants in China.
TJ011133 is not FDA approved. It is an investigational drug that has completed Phase 1 clinical trials, but it has not received marketing authorization from the FDA or any other regulatory agency. Further clinical development would be required before any approval could be considered.