PF-07104091 as a Single Agent and in Combination Therapy
PHASE 1/2A DOSE ESCALATION, FINDING AND EXPANSION STUDY EVALUATING SAFETY, TOLERABILITY, PHARMACOKINETICS, PHARMACODYNAMICS AND ANTI TUMOR ACTIVITY OF PF-07104091 AS A SINGLE AGENT AND IN COMBINATION THERAPY
2 other identifiers
interventional
157
4 countries
22
Brief Summary
To assess the safety and tolerability of increasing doses of PF-07104091 and to estimate the Maximum Tolerated Dose (MTD) and/or select the Recommended Phase 2 dose (RP2D) for PF-07104091 as a single agent in participants with advanced or metastatic small cell lung, breast and ovarian cancers.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Sep 2020
Longer than P75 for phase_2
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 21, 2020
CompletedStudy Start
First participant enrolled
September 16, 2020
CompletedFirst Posted
Study publicly available on registry
September 17, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2026
May 6, 2026
May 1, 2026
6.3 years
August 21, 2020
May 4, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (6)
Dose Escalation: Number of participants with Dose-limiting toxicities (DLT) during first cycle
Number of participants with DLTs, which are typically Grade 3 or higher adverse events will be summarized by dose level
28 days
To evaluate incidence of treatment emergent adverse events and laboratory abnormalities
Type, incidence, severity, timing, seriousness and relationship to study treatment of adverse events and any laboratory abnormalities will be summarized by dose level
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
Identify pulse rate readings that are outside the normal range. The number and percentage of participants who experienced significant pulse rate change from baseline will be summarized by dose level
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
Identify systolic and diastolic readings that are outside the normal range. The number and percentage of participants who experienced significant blood pressure change from baseline will be summarized by dose level
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
Determine the effect of the drug on QT prolongation. The number and percentage of participants who experienced QT interval prolongation will be summarized by dose level
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
Percentage of participants with a best overall response of complete response (CR) or partial response (PR) using RECIST 1.1
From baseline through disease progression or study completion (approximately 2 years)
Secondary Outcomes (7)
Maximum plasma concentration (Cmax) of PF-07104091 after a single dose and multiple dose
Day 1 and Day 15 of Cycle 1 (each cycle is 28 days)
Time to maximum plasma concentration (Tmax) of PF-07104091 after a single dose and multiple dose
Day 1 and Day 15 of Cycle 1 (each cycle is 28 days)
Area under the concentration versus time curve from time zero to the last quantifiable time point prior to the next dose (AUClast) of PF-07104091
Day 1 and Day 15 of Cycle 1 (each cycle is 28 days)
Area under the curve of PF-07104091 with or without food
From baseline through time to event on study or study completion (approximately 2 years)
Maximum plasma concentration of PF-07104091 with or without food
From baseline through time to event on study or study completion (approximately 2 years)
- +2 more secondary outcomes
Study Arms (7)
PF-07104091
EXPERIMENTALCDK2 monotherapy dose escalation
PF-07104091 + palbociclib + fulvestrant
EXPERIMENTALCDK2 + palbociclib + fulvestrant
PF-07104091 + palbociclib + letrozole
EXPERIMENTALCDK2 + palbociclib + letrozole
PF-07104091 monotherapy dose expansion (SCLC)
EXPERIMENTALPF-07104091 monotherapy dose expansion (SCLC)
PF-07104091 monotherapy dose expansion (ovarian)
EXPERIMENTALPF-07104091 monotherapy dose expansion (ovarian)
PF-07104091 + fulvestrant (post CDK4/6) dose expansion
EXPERIMENTALPF-07104091 + fulvestrant (post CDK4/6) dose expansion
PF-07104091 + fulvestrant (post CDK 4/6) dose escalation
EXPERIMENTALCDK2+ fulvestrant (post CDK 4/6) dose escalation
Interventions
PF-07104091 + fulvestrant (post 4/6) dose expansion
PF-07104091 will be administered orally in combination with palbociclib and fulvestrant
PF-07104091 will be administered orally in combination with palbociclib and letrozole
PF-07104091 will be administered orally
PF-07104091 will be administered orally
PF-07104091 will be administered orally in combination with fulvestrant
Eligibility Criteria
You may qualify if:
- Participants with HR-positive HER2-negative advanced or metastatic breast cancer (received at least two prior lines in the advanced or metastatic setting including one prior line of combined CDK4/6 inhibitor and endocrine therapy and no more than two prior lines of cytotoxic chemotherapy)
- Participants with locally recurrent/advanced or metastatic TNBC who have received up to 2 prior lines of chemotherapy in the advanced or metastatic setting
- Participants with advanced platinum resistant epithelial ovarian cancer (EOC)/fallopian tube cancer/primary peritoneal cancer (PPC) (histologically or cytologically proven) who have received at least 1 systemic anti-cancer therapy containing a platinum analog
- Participants with cytological diagnosis of advanced/metastatic SCLC
- Participants with or cytological diagnosis of advanced/metastatic NSCLC
- Participants with HR-positive HER2-negative advanced or metastatic breast cancer (second line plus setting) (histologically or cytologically proven).
- Participants entering the study in the expansion cohort have at least one measurable lesion as defined by RECIST version 1.1 that has not been previously irradiated
- Performance Status 0 or 1
- Adequate bone marrow, hematological, kidney and liver function
- Resolved acute effects of any prior therapy to baseline severity
You may not qualify if:
- Participants with known symptomatic brain metastases requiring steroids
- Participants with any other active malignancy within 3 years prior to enrollment
- Major surgery within 3 weeks prior to study entry
- Radiation therapy within 3 weeks prior to study entry.
- Systemic anti cancer therapy within 4 weeks prior to study
- Prior irradiation to \>25% of the bone marrow
- Participants with active, uncontrolled bacterial, fungal, or viral infection, including HBV, HCV, and known HIV or AIDS related illness
- Active COVID-19/SARS-CoV2 infection
- Baseline 12 lead ECG that demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of study results
- Any of the following in the previous 6 months: myocardial infarction, long QT syndrome, Torsade de Pointes, arrhythmias, serious conduction system abnormalities, unstable angina, coronary/peripheral artery bypass graft, symptomatic CHF, New York Heart Association class III or IV, cerebrovascular accident, transient ischemic attack, symptomatic pulmonary embolism, and/or other clinical significant episode of thrombo embolic disease.
- Anticoagulation with vitamin K antagonists or factor Xa inhibitors is not allowed.
- Hypertension that cannot be controlled by medications
- Participation in other studies involving investigational drug(s) within 2 weeks prior to study entry.
- Known or suspected hypersensitivity to active ingredient/excipients in PF 07104091.
- Active inflammatory gastrointestinal disease, chronic diarrhea, known diverticular disease or previous gastric resection or lap band surgery.
- +8 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (22)
Medical Oncology & Hematology Associates DBA Mission Cancer and Blood
Clive, Iowa, 50325, United States
Des Moines Oncology Research Association
Des Moines, Iowa, 50309, United States
Medical Oncology & Hematology Associates DBA Mission Cancer and Blood
Des Moines, Iowa, 50309, United States
Medical Oncology & Hematology Associates DBA Mission Cancer and Blood
Des Moines, Iowa, 50314, United States
Norton Hospital
Louisville, Kentucky, 40202, United States
Norton Cancer Institute, St. Matthews Campus
Louisville, Kentucky, 40207, United States
Norton Cancer Institute, Audubon
Louisville, Kentucky, 40217, United States
Norton Brownsboro Hospital
Louisville, Kentucky, 40241, United States
Norton Cancer Institute, Brownsboro Campus
Louisville, Kentucky, 40241, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Dana-Farber Cancer Institute - Chestnut Hill
Newton, Massachusetts, 02459, United States
Memorial Sloan Kettering Monmouth
Middletown, New Jersey, 07748, United States
Memorial Sloan Kettering Cancer Center (IDS Pharmacy)
Long Island City, New York, 11101, United States
Laura & Isaac Perlmutter Cancer Center - NYU ACC
New York, New York, 10016, United States
NYU Langone Medical Center (Tisch Hospital)
New York, New York, 10016, United States
White Plains Hospital
White Plains, New York, 10601, United States
UVA Breast Care Center
Charlottesville, Virginia, 22911, United States
Centro de Investigaciones Medicas y Desarrollo LC
Buenos Aires, Buenos Aires F.D., 1113, Argentina
Complex Oncology Center - Plovdiv EOOD
Plovdiv, 4004, Bulgaria
Complex Oncology Center - Shumen
Shumen, 9700, Bulgaria
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032, China
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, 300060, China
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 21, 2020
First Posted
September 17, 2020
Study Start
September 16, 2020
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
December 31, 2026
Last Updated
May 6, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will share
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.