Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Oprozomib · 2 trials · 2 indications
MTD is defined as the highest dose at which a DLT is observed in less than 2 of 6 evaluable subjects occurring within the 4 weeks after the first dose of combination therapy.
ORR defined as a best overall response of sCR, CR, VGPR, or PR according to the IMWG-URC.
CRR defined as a best overall response of sCR or CR according to the IMWG-URC.
* To evaluate the safety and tolerability of Oprozomib in patients with advanced refractory or recurrent solid tumors including determination of its Dose Limiting Toxicity (DLT) and Maximum Tolerated Dose (MTD) * To determine the pharmacokinetics (PK) of Oprozomib
| Arm | Type | Description |
|---|---|---|
| Oprozomib with Melphalan and Prednisone (OMP) | EXPERIMENTAL | Subjects will receive oprozomib administered orally. The combination of oprozomib, melphalan, and prednisone (OMP) will be administered until progression of disease, unacceptable toxicity, discontinuation of study treatment for reasons other than progression or toxicity, or a maximum of 9 cycles (54 weeks), whichever occurs first. |
| Oprozomib | EXPERIMENTAL | Phase I, Dose Escalation, Single Arm, Open Label |
| Name | Type | Description |
|---|---|---|
| Oprozomib | DRUG | Study subjects will receive oprozomib administered orally. |
| Melphalan | DRUG | Study subjects will receive melphalan 9 mg/m2. |
| Prednisone | DRUG | Study subjects will receive prednisone 60 mg/m2. |
Key Inclusion Criteria: 1. Newly diagnosed symptomatic multiple myeloma patients who are transplant ineligible with measureable disease as indicated by one or more of the following: 1. Serum M-protein ≥ 500 mg/dL 2. Urine M-protein ≥ 200 mg/24 hour 3. Serum Free Light Chain: Involved free...
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Oprozomib is an investigational small molecule being studied in oncology for multiple myeloma and solid tumors. It has been evaluated in Phase 1 clinical trials, including one in transplant ineligible patients with newly diagnosed multiple myeloma and another in patients with advanced refractory or recurrent solid tumors.
Oprozomib targets the proteasome subunits PSMD1, PSMB2, PSMB1, PSMB5, PSMB8, and PSMB9. It acts as an inhibitor of these targets, which are components of the proteasome complex involved in protein degradation within cells.
Oprozomib is being developed by Amgen Inc., a biotechnology company traded on the Nasdaq under the ticker symbol AMGN.
Oprozomib is in Phase 1 clinical development. It is an investigational agent and has not been approved by the FDA for any indication.
Oprozomib has been studied in two completed Phase 1 trials: NCT02072863, which evaluated oprozomib with melphalan and prednisone in transplant ineligible patients with newly diagnosed multiple myeloma, and NCT01129349, which tested oral oprozomib in patients with advanced refractory or recurrent solid tumors.