Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
LM-302 · 1 trial · 1 indication
DLT is defined as a toxicity (adverse event at least possibly related to LM302) occurring during the DLT observation period
The safety profile of LM302 will be assessed by monitoring the adverse events (AE) per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0
Change in vital signs-ear temperature will be measured after the subject has been fully rested
Change in vital signs-pluse rate will be measured after the subject has been fully rested.
Change in vital signs-systolic pressure will be measured after the subject has been fully rested.
Change in vital signs-diastolic blood pressure will be measured after the subject has been fully rested.
Change in Physical examination-weight will be measured with only light clothes
Number of participants with incidence of abnormal clinical lab test results like hematology will be assessed.
Number of participants with incidence of abnormal clinical lab test results like Biochemistry will be assessed
Number of participants with incidence of abnormal clinical lab test results like Urinalysis will be assessed.
Number of participants with incidence of abnormal clinical lab test results like Coagulation test will be assessed
RR interval of 12-lead ECG will be performed in the supine position after the patients are fully rested at each timepoint for once. RR is the standard heart rate which calculated by 60 divided by heart rate.
QT interval of 12-lead ECG will be performed in the supine position after the patients are fully rested at each timepoint for once.
QRS duration of 12-lead ECG will be performed in the supine position after the patients are fully rested at each timepoint for once.
| Arm | Type | Description |
|---|---|---|
| LM302 Dose Escalation Level 1, 0.2 mg/kilogram(kg), | EXPERIMENTAL | The dose escalation scheme using the the accelerated titration design for dose 1 and the i3+3 design for the remaining doses. first dose: 0.2mg/kg i.v. every 3 weeks (1 cycle=21 days) , n=1; |
| LM302 Dose Escalation Level 2, 0.4 mg/kg | EXPERIMENTAL | The dose escalation scheme using the the accelerated titration design for dose 1 and the i3+3 design for the remaining doses. second dose: 0.4mg/kg i.v. every 3 weeks (1 cycle=21 days) , n=3; |
| LM302 Dose Escalation Level 3, 0.8 mg/kg | EXPERIMENTAL | The dose escalation scheme using the the accelerated titration design for dose 1 and the i3+3 design for the remaining doses. third dose: 0.8mg/kg i.v. every 3 weeks (1 cycle=21 days) , n=6; |
| LM302 Dose Escalation Level 4, 1.6mg/kg | EXPERIMENTAL | The dose escalation scheme using the the accelerated titration design for dose 1 and the i3+3 design for the remaining doses. fourth dose: 1.6mg/kg i.v. every 3 weeks (1 cycle=21 days) , n=6; |
| LM302 Dose Escalation Level 5, 2.4mg/kg | EXPERIMENTAL | The dose escalation scheme using the the accelerated titration design for dose 1 and the i3+3 design for the remaining doses. fifth dose: 1.6mg/kg i.v. every 3 weeks (1 cycle=21 days) , n=9; |
| LM302 Dose Escalation Level 6, 2.8mg/kg | EXPERIMENTAL | The dose escalation scheme using the the accelerated titration design for dose 1 and the i3+3 design for the remaining doses. sixth dose: 1.6mg/kg i.v. every 3 weeks (1 cycle=21 days) , n=12; |
| Name | Type | Description |
|---|---|---|
| LM-302 | DRUG | All subjects will be administered every 3 weeks (1 cycle=21 days) with a dose of LM-302 intravenous infusion on day 1 until meet the criteria of treatment discontinuation or withdraw, whichever occurs earlier. |
Inclusion Criteria: * Subjects who are fully informed of the purpose, nature, method and possible adverse reactions of the study, and are willing to participate in the study and sign the informed consent form (ICF) prior to any procedure; * Aged ≥18 years old when sign the ICF, male or female; * Ea...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Merck & Co., Inc. | MRK | 2 | PHASE2 | pembrolizumab |
| Incyte Corporation | INCY | 1 | PHASE2 | Chemotherapy, Retifanlimab |
| Iovance Biotherapeutics Inc | IOVA | 2 | PHASE2 | E7 TCR-T cells, Aldesleukin |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE1 | KFA115, pembrolizumab |
| AstraZeneca PLC | AZN | 1 | - | Trastuzumab deruxtecan |
LM-302 is an investigational small molecule being studied for the treatment of advanced solid tumors. It is currently in Phase 1 clinical development, with one completed trial that enrolled 17 patients in the United States. The drug is not yet approved and remains under investigation.
The molecular target of LM-302 has not been disclosed in available information. As a small molecule in oncology, it is being evaluated for its potential activity against advanced solid tumors, but its specific mechanism of action is not publicly detailed.
LM-302 is being developed by Bristol-Myers Squibb Company, which trades under the ticker BMY on the stock exchange. The company is conducting clinical research on this investigational oncology drug for advanced solid tumors.
LM-302 is in Phase 1 clinical development. It is an investigational drug, meaning it has not received regulatory approval and is still being studied for safety and efficacy in patients with advanced solid tumors.
LM-302 has one completed clinical trial, identified as NCT05001615, titled 'Study of Turning Point Therapeutics LM-302 in Patients With Advance Solid Tumors.' This Phase 1 study enrolled 17 participants in the United States and was not randomized or double-blinded.
Yes, LM-302 is the same drug referred to as Turning Point Therapeutics LM-302 in clinical trial records. The trial NCT05001615 uses this name, and the drug is now associated with Bristol-Myers Squibb, the current developer.