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Also known as PF-07248144, Oral [14C] PF-07248144, prifetrastat Reference
Prifetrastat · 3 trials · 5 indications
A Guardant Health (Guardant360® CDx) assay will be used for ctDNA detection and sequencing and evaluation of tumor mutation burden defined by the mean change in Variant Allele Frequency (VAF) of 74 prespecified genes, from cycle 1 to cycle 3. Primary endpoint will be evaluated per cohort (as defined in section "Therapeutic regimen" below) and in the overall population.
Dose-limiting toxicities (DLTs)
Adverse Events as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), timing, seriousness, and relationship to study therapy.
Laboratory abnormalities as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), and timing.
Adverse Events as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), timing, seriousness, and relationship to study therapy.
Laboratory abnormalities as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), and timing.
| Arm | Type | Description |
|---|---|---|
| Arm A: PF-07248144 plus fulvestrant | OTHER | PF-07248144 tablet taken by mouth plus fulvestrant taken as a shot into the muscle. |
| Arm B: everolimus plus ET | ACTIVE_COMPARATOR | Everolimus tablet taken by mouth plus investigator's choice of endocrine therapy of exemestane tablet taken by mouth or fulvestrant taken as a shot into the muscle. |
| Cohort 1 : prifetrastat monotherapy for 15days then combination with fulvestrant | EXPERIMENTAL | Patients will receive prifetrastat 5mg QD monotherapy for 2 weeks and then combination of prifetrastat 5mg QD plus fulvestrant 500-mg intramuscular injection on day 15 cycle 1, on day 1 and day 15 of cycle 2 and then on day 15 of subsequent 28-day (±3 days) cycles. In both cohorts, men and premenopausal women will receive in addition a LH-RH analogue (goserelin, leuprorelin or triptorelin) every 28 days ±3 days, as per standard practice. Administration schedule of the analogue will follow the same schedule as described for fulvestrant, which depends on the allocated cohort. |
| Cohort 2 : prifetrastat incombination with fulvestrant | EXPERIMENTAL | Patients will receive combination prifetrastat 5mg QD plus fulvestrant 500-mg intramuscular injection on days 1 and 15 of cycle 1 and on day 1 of subsequent 28-day (±3 days) cycles. In both cohorts, men and premenopausal women will receive in addition a LH-RH analogue (goserelin, leuprorelin or triptorelin) every 28 days ±3 days, as per standard practice. Administration schedule of the analogue will follow the same schedule as described for fulvestrant, which depends on the allocated cohort. |
| 1A Monotherapy Dose Escalation | EXPERIMENTAL | PF-07248144 Monotherapy Escalation |
| 1B Combination Dose Escalation | EXPERIMENTAL | PF-07248144 with Fulvestrant Combination Dose Escalation |
| 1C Combination Dose Escalation | EXPERIMENTAL | PF-07248144 with Letrozole + Palbociclib Combination Dose Escalation |
| 2A Monotherapy Dose Expansion Arm | EXPERIMENTAL | PF-07248144 Monotherapy Dose Expansion |
| 2B Combination Dose Expansion Arm | EXPERIMENTAL | PF-07248144 with Fulvestrant Dose Expansion |
| 1D Combination Dose Escalation | EXPERIMENTAL | PF-07248144 with PF-07220060 +Fulvestrant |
| 2D Combination Dose Expansion Arm | EXPERIMENTAL | PF-07248144 with PF-07220060 +Fulvestrant Dose Expansion |
| China Monotherapy Dose Expansion | EXPERIMENTAL | PF-07248144 Monotherapy Dose Expansion |
| 1E Combination Dose Escalation | EXPERIMENTAL | PF-07248144 with Vepdegestrant Combination Dose Escalation |
| 2E Combination Dose Expansion Arm | EXPERIMENTAL | PF-07248144 with Vepdegestrant Combination Dose Expansion |
| Name | Type | Description |
|---|---|---|
| PF-07248144 | DRUG | KAT6 inhibitor |
| Fulvestrant | DRUG | Endocrine therapy |
| Everolimus | DRUG | mTOR inhibitor |
| Exemestane | DRUG | Endocrine therapy |
| prifetrastat monotherapy for 15 days then combination with fulvestrant | DRUG | Patients will receive prifetrastat 5mg QD monotherapy for 2 weeks and then combination of prifetrastat 5mg QD plus fulvestrant 500-mg intramuscular injection on day 15 cycle 1, on day 1 and day 15 of cycle 2 and then on day 15 of subsequent 28-day (±3 days) cycles. |
| prifetrastat in combination with fulvestrant | DRUG | Patients will receive combination prifetrastat 5mg QD plus fulvestrant 500-mg intramuscular injection on days 1 and 15 of cycle 1 and on day 1 of subsequent 28-day (±3 days) cycles |
| Letrozole | DRUG | Endocrine Therapy |
| Palbociclib | DRUG | CDK4/6 Inhibitor |
| PF-07220060 | DRUG | CDK4 inhibitor |
| PF-07850327, ARV-471, vepdegestrant | DRUG | PROTAC (PROteolysis Targeting Chimera) ER degrader |
Inclusion Criteria: * Confirmed diagnosis of HR-positive HER2-negative breast cancer with evidence of locally advanced or metastatic disease, which is not amenable to surgical resection or radiation therapy with curative intent. * Prior CDK4/6 inhibitor therapy in combination with endocrine therapy...
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Prifetrastat is an investigational small molecule developed by Pfizer, Inc. (PFE) for the treatment of cancer. It is being studied in breast cancer, including locally advanced or metastatic ER+ HER2- breast cancer, and in metastatic (Stage IV) melanoma. It is not yet approved and remains in clinical development.
Prifetrastat is being studied for HR-positive, HER2-negative advanced or metastatic breast cancer, including patients who progressed after a prior line of treatment. It is also being evaluated in locally advanced or metastatic ER+ HER2- breast cancer. It is investigational and has not been approved for any indication.
Prifetrastat is a small molecule in the -stat (enzyme) target class, meaning it acts as an enzyme inhibitor. It is studied as monotherapy and in combination with fulvestrant. The trials are biomarker-selected, so enrollment depends on specific biomarker criteria.
Prifetrastat is developed by Pfizer, Inc., which trades under the ticker PFE. Pfizer is running the clinical program, including a Phase 3 study in HR-positive, HER2-negative advanced or metastatic breast cancer and earlier-phase studies in solid tumors.
Prifetrastat is in Phase 3 development. The Phase 3 trial, NCT07062965, is recruiting and plans to enroll 400 participants with HR-positive, HER2-negative advanced or metastatic breast cancer who progressed after a prior line of treatment. Prifetrastat is investigational and not FDA approved.
Prifetrastat is being studied in NCT07062965, a recruiting Phase 3 trial of prifetrastat plus fulvestrant in advanced or metastatic breast cancer across many countries. NCT04606446 is a recruiting Phase 2 study in advanced solid tumors, and NCT07340619 is a Phase 2 trial in France that is not yet recruiting.
Yes, prifetrastat is also known as PF-07248144. Other names used in study records include oral [14C] PF-07248144, prifetrastat monotherapy for 15 days then combination with fulvestrant, and prifetrastat in combination with fulvestrant. These all refer to the same Pfizer compound.