Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
HDM201 · 2 trials · 2 indications
DLTs in the first cycle of treatment.
as measured by AUC0-24h
To assess the preliminary anti-tumor activity of HDM201 in combination with LEE011 in liposarcoma
DLTs in the first cycle of treatment.
| Arm | Type | Description |
|---|---|---|
| HDM201+LEE011 | EXPERIMENTAL | - |
| Arm A | EXPERIMENTAL | - |
| Arm B | EXPERIMENTAL | - |
| Arm C | EXPERIMENTAL | - |
| Arm D | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| HDM201 | DRUG | - |
| LEE011 | DRUG | - |
| ancillary treatment | DRUG | - |
Inclusion Criteria: * Patients with histologically documented, locally advanced or metastatic WD/DD liposarcoma who have received at least one prior systemic therapy * Patients with radiologic progression, defined by RECIST v.1.1, occurring while on/or within 6 months after last systemic treatment,...
HDM201 is an investigational small molecule being studied for the treatment of advanced solid and hematological TP53wt tumors, as well as liposarcoma. It is in Phase 1 clinical development and is not yet approved by regulatory authorities.
HDM201 is designed to target tumors that are TP53 wild-type (TP53wt), meaning they have a normal, non-mutated p53 gene. The drug is being evaluated in patients with advanced solid and hematological TP53wt tumors and liposarcoma.
HDM201 is being developed by Novartis AG, a multinational pharmaceutical company listed on the New York Stock Exchange under the ticker symbol NVS. The drug is currently in Phase 1 clinical trials.
HDM201 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA or any other regulatory agency. Two Phase 1 trials have been completed, one as a single agent and one in combination with LEE011.
HDM201 has been studied in two completed Phase 1 trials. NCT02143635 evaluated HDM201 as a single agent in 208 patients with advanced solid and hematological TP53wt tumors. NCT02343172 evaluated HDM201 in combination with LEE011 in 74 patients with liposarcoma.
HDM201 is also known by the code name HDM201. It is not known to be the same as any other marketed drug. It is an investigational compound being developed by Novartis for oncology indications.