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PF-07104091 as a Single Agent...

PF-07104091 as a Single Agent and in Combination Therapy

Last Updated: 2025-08-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

154 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-16

Study Completion Date

2026-03-30

Brief Summary

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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.

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Detailed Description

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Study C4161001 is a Phase 1, open label, multi dose, multi center, dose escalation, safety, pharmacokinetic (PK) and pharmacodynamic study of PF-07104091 in adult patients with advanced or metastatic small cell lung cancer (SCLC), advanced platinum resistant epithelial ovarian cancer/fallopian tube cancer/primary peritoneal cancer, locally recurrent/advanced or metastatic triple negative breast cancer (TNBC), HR-positive HER2-negative advanced or mBC, advanced or metastatic non-small cell lung cancer (NSCLC). This two part study will assess the safety and tolerability of increasing dose levels of PF-07104091 in Part 1, and establish the recommended Phase 2 dose (RP2D) in Part 2.

Conditions

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Small Cell Lung Cancer Ovarian Cancer Breast Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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PF-07104091

CDK2 monotherapy dose escalation

Group Type EXPERIMENTAL

PF-07104091 monotherapy dose escalation

Intervention Type DRUG

PF-07104091 will be administered orally

PF-07104091 + palbociclib + fulvestrant

CDK2 + palbociclib + fulvestrant

Group Type EXPERIMENTAL

PF-07104091 + palbociclib + fulvestrant

Intervention Type DRUG

PF-07104091 will be administered orally in combination with palbociclib and fulvestrant

PF-07104091 + palbociclib + letrozole

CDK2 + palbociclib + letrozole

Group Type EXPERIMENTAL

PF-07104091 + palbociclib + letrozole

Intervention Type DRUG

PF-07104091 will be administered orally in combination with palbociclib and letrozole

PF-07104091 monotherapy dose expansion (SCLC)

Group Type EXPERIMENTAL

PF-07104091 monotherapy dose expansion (SCLC)

Intervention Type DRUG

PF-07104091 will be administered orally

PF-07104091 monotherapy dose expansion (ovarian)

Group Type EXPERIMENTAL

PF-07104091 monotherapy dose expansion (ovarian)

Intervention Type DRUG

PF-07104091 will be administered orally

PF-07104091 + fulvestrant (post CDK4/6) dose expansion

Group Type EXPERIMENTAL

PF-0704091 + Fulvestrant (post CDK4/6)

Intervention Type DRUG

PF-07104091 + fulvestrant (post 4/6) dose expansion

PF-07104091 + fulvestrant (post CDK 4/6) dose escalation

CDK2+ fulvestrant (post CDK 4/6) dose escalation

Group Type EXPERIMENTAL

PF-07104091 + Fulvestrant (post CDK4/6)

Intervention Type DRUG

PF-07104091 will be administered orally in combination with fulvestrant

Interventions

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PF-07104091 monotherapy dose escalation

PF-07104091 will be administered orally

Intervention Type DRUG

PF-07104091 + palbociclib + fulvestrant

PF-07104091 will be administered orally in combination with palbociclib and fulvestrant

Intervention Type DRUG

PF-07104091 + palbociclib + letrozole

PF-07104091 will be administered orally in combination with palbociclib and letrozole

Intervention Type DRUG

PF-07104091 monotherapy dose expansion (ovarian)

PF-07104091 will be administered orally

Intervention Type DRUG

PF-07104091 monotherapy dose expansion (SCLC)

PF-07104091 will be administered orally

Intervention Type DRUG

PF-07104091 + Fulvestrant (post CDK4/6)

PF-07104091 will be administered orally in combination with fulvestrant

Intervention Type DRUG

PF-0704091 + Fulvestrant (post CDK4/6)

PF-07104091 + fulvestrant (post 4/6) dose expansion

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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.
* Participants with advanced/metastatic, symptomatic, visceral spread, that are at risk of life threatening complications in the short
* Participants with an indwelling catheter that has an external component such as those used for drainage of effusion(s) or central venous catheter that is externally
* Previous high dose chemotherapy requiring stem cell rescue
* Known abnormalities in coagulation such as bleeding diathesis, or treatment with anticoagulants precluding intramuscular injections of goserelin (if applicable).
* Current use or anticipated need for food or drugs that are known strong CYP3A4/5 or UGT1A9 inhibitors or inducers
* Current use or anticipated need for drugs that are known sensitive UGT1A1 substrates with narrow therapeutic
* Serum pregnancy test positive at screening
* Other medical or psychiatric condition

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Medical Oncology & Hematology Associates DBA Mission Cancer and Blood

Clive, Iowa, United States

Site Status

Des Moines Oncology Research Association

Des Moines, Iowa, United States

Site Status

Medical Oncology & Hematology Associates DBA Mission Cancer and Blood

Des Moines, Iowa, United States

Site Status