PF-07104091 as a Single Agent and in Combination Therapy
← catalyst calendarNCT04553133 · readout in 134 d
Sponsored by Pfizer (industry) · PFE — their whole pipeline →.
Phase
Phase 2
Status
Active, not recruiting
Study type
Interventional
Design
Non randomized · None · Treatment
Enrollment
157actual
Sites
22
Countries
Argentina, Bulgaria, China +1
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2020-09-16 | actual | When the study began enrolling |
| Primary completion | 2026-12-31 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2026-12-31 | estimated | The whole study's end, after follow-up |
| First posted | 2020-09-17 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-05-06 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Small Cell Lung Cancer
- Ovarian Cancer
- Breast Cancer
Interventions
- Drug: PF-07104091 monotherapy dose escalation
- Drug: PF-07104091 + palbociclib + fulvestrant
- Drug: PF-07104091 + palbociclib + letrozole
- Drug: PF-07104091 monotherapy dose expansion (ovarian)
- Drug: PF-07104091 monotherapy dose expansion (SCLC)
- Drug: PF-07104091 + Fulvestrant (post CDK4/6)
- Drug: PF-0704091 + Fulvestrant (post CDK4/6)
Primary outcomes
what the primary-completion date above is the date OFDose Escalation: Number of participants with Dose-limiting toxicities (DLT) during first cycle
measured 28 days
To evaluate incidence of treatment emergent adverse events and laboratory abnormalities
measured From baseline until end of study treatment or study completion (approximately 2 years)
Evaluate pulse rate that is out of normal range and changes in pulse rate as compared to baseline
measured From baseline until end of study treatment or study completion (approximately 2 years)
Evaluate blood pressure that is out of normal range and changes in blood pressure as compared to baseline
measured From baseline until end of study treatment or study completion (approximately 2 years)
To evaluate heart rate corrected QT interval and changes in corrected QT interval as compared to baseline
measured From baseline until end of study treatment or study completion (approximately 2 years)
To evaluate the preliminary antitumor activity of PF-07104091 as a single agent and in combination with palbociclib and in combination with letrozole or fulvestrant or fulvestrant alone by objective response rate (ORR) in dose expansion
measured From baseline through disease progression or study completion (approximately 2 years)
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