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 | 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 |
LM-302 is an investigational small molecule being studied for the treatment of advanced solid tumors. It is being developed in oncology and was evaluated in a biomarker-selected patient population. LM-302 has not been approved for any indication and remains in clinical development.
LM-302 is being developed by Bristol-Myers Squibb Company, which trades on the New York Stock Exchange under the ticker BMY. The Phase 1 study of LM-302 was titled Study of Turning Point Therapeutics LM-302 in Patients With Advance Solid Tumors.
LM-302 is in Phase 1 clinical development. Its single registered trial, NCT05001516, was a Phase 1 study in patients with advanced solid tumors. That trial is now completed, and LM-302 is an investigational agent that has not been approved by the FDA.
LM-302 has been studied in one clinical trial, NCT05001516, titled Study of Turning Point Therapeutics LM-302 in Patients With Advance Solid Tumors. The Phase 1 trial enrolled 17 patients in the United States, included adults 18 years and older of all sexes, and is completed.
The Phase 1 trial of LM-302, NCT05001516, was not randomized and was not double blinded. It used a controlled design and enrolled 17 patients with advanced solid tumors. The study was biomarker selected and did not include healthy volunteers.