Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as PF-06821497, Mervometostat (PF-06821497), Mevrometostat
Mervometostat · 1 trial · 3 indications
First cycle DLTs will be utilized to determine the MTD
Adverse Events will be graded by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE version \[4.03\])
Objective response using Response Evaluation Criteria in Lymphoma (RECIL) for lymphoma, Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 for solid tumors including Small Cell Lung Cancer (SCLC) and Prostate Cancer Working Group 3 (PCWG3) for Castration Resistant Prostate Cancer (CRPC). Progression-free survival in Part 2B in patients with CRPC.
Laboratory abnormalities as characterized by type, frequency, severity (as graded by NCI CTCAE version \[4.03\]), and timing.
Vital sign changes from baseline including blood pressure, heart rate, ECG changes.
PCWG3
| Arm | Type | Description |
|---|---|---|
| Dose Escalation (Part 1A) | EXPERIMENTAL | Participants with SCLC, CRPC and FL will receive mevrometostat at escalating dose levels |
| Dose Escalation (Part 1B) | EXPERIMENTAL | Participants with FL will receive mevrometostat at escalating dose levels |
| Dose Escalation (Part 1C) | EXPERIMENTAL | Participants with mCRPC will receive mevrometostat at escalating dose levels. |
| Dose Escalation (Part 2A) | EXPERIMENTAL | Participants with mCRPC and SCLC will receive mevrometostat at escalating dose levels in combination with SOC. |
| Dose Expansion (Part 2B) | EXPERIMENTAL | Participants with CRPC will receive mevrometostat in combination with SOC or SOC alone. |
| Japan Cohort | EXPERIMENTAL | Participants with CRPC will receive mevrometostat at one or two doses |
| China cohort | EXPERIMENTAL | Participants will receive mevrometostat at one or two doses |
| Dose Expansion (Part 2C) | EXPERIMENTAL | Participants with mCRPC will receive mevrometostat at a different dose/dosing regimen than that of Part 2B in combination with SOC |
| BE Substudy | EXPERIMENTAL | In the assessment phase, each enrolled participant will receive single doses of the 2 different mevrometostat formulations in 3 periods with alternating dosing and washout between each dose. In the maintenance phase, each participant will receive mevrometostat 2 times a day and enzalutamide 1 time a day. |
| DDI Substudy | EXPERIMENTAL | The DDI substudy assessment phase will consist of 2 Cohorts, Cohort 1 (monotherapy cohort) and Cohort 2 (combination cohort). In the Cohort 1 assessment phase, each enrolled participant will receive a combination of mevrometostat and itraconazole based on preset schedule. In the Cohort 2 assessment phase, each enrolled participant will receive a combination of mevrometostat, enzalutamide, and itraconazole based on preset schedule. In the maintenance phase, each participant will receive mevrometostat 2 times a day and enzalutamide 1 time a day. |
| Name | Type | Description |
|---|---|---|
| Mervometostat (PF-06821497) | DRUG | Oral continuous |
| Enzalutamide | DRUG | Oral continuous |
| Itraconazole | DRUG | Oral solution |
Part 1 and Part 2 (Closed for enrollment). Part 3 Key Inclusion Criteria: * Histological or cytological diagnosis of castration resistant prostate cancer. * Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0-2 with expected life expectancy of at least 6 months. * Adequate bone ...
Mervometostat is an investigational small molecule being developed by Pfizer for metastatic castration-resistant prostate cancer (mCRPC) and metastatic castration-sensitive prostate cancer (mCSPC). It is also being studied in healthy participants to understand how the drug is processed by the body.
Mervometostat is a small molecule enzyme inhibitor, classified under the -stat (enzyme) target class. It is being studied to treat prostate cancer by targeting specific enzymes involved in cancer growth, though the exact molecular target is not disclosed in the available information.
Mervometostat is developed by Pfizer, Inc., a biopharmaceutical company listed on the New York Stock Exchange under the ticker symbol PFE. The drug is also known by the code name PF-06821497.
Mervometostat is in Phase 1 clinical development for metastatic castration-resistant prostate cancer and metastatic castration-sensitive prostate cancer. It is also being studied in healthy participants. The drug is investigational and has not been approved by regulatory authorities.
Mervometostat is being studied in several clinical trials. NCT03460977 is a Phase 1 trial in mCRPC, small cell lung cancer, and follicular lymphoma. NCT06392230 is a completed Phase 1 trial in healthy participants. NCT06629779 is a Phase 3 trial in mCRPC, and NCT07028853 is a Phase 3 trial in mCSPC.
Yes, Mervometostat is also known as PF-06821497. The drug is referred to by both names in clinical trial registries and scientific literature, with PF-06821497 being the code name used during early development.