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

New Cancer Drug Trial for Advanced Breast, Ovarian, and Lung Cancers

NCT: NCT04553133 · Status: ACTIVE NOT RECRUITING · Phase: Phase 2 · Sponsor: Pfizer · Started: 2020-09-16 · Est. Completion: 2026-03-30

Plain English Summary

PF-07104091 as a Single Agent and in Combination Therapy is a Phase 2 clinical trial sponsored by Pfizer studying Small Cell Lung Cancer, Ovarian Cancer, Breast Cancer. This trial tests a new drug, PF-07104091, alone or with other cancer treatments. It is for adults with advanced or metastatic breast, ovarian, or small cell lung cancer. Participants will receive increasing doses of the drug to find the safest and most effective dose. Standard treatments or participation in other drug trials are potential alternatives. The trial aims to enroll 154 participants.

Official 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.

Who Can Participate

Here is what you need to know about eligibility for this trial. You may be eligible if you have advanced breast cancer (HR-positive, HER2-negative) that has been treated with at least two prior therapies, including a CDK4/6 inhibitor and hormone therapy. You may also be eligible if you have advanced triple-negative breast cancer (TNBC) treated with up to two prior chemotherapy regimens. Eligibility extends to those with platinum-resistant ovarian cancer or advanced small cell lung cancer (SCLC) or non-small cell lung cancer (NSCLC). You cannot join if you have brain metastases requiring steroids, other active cancers within the last 3 years, or significant heart conditions. This trial is studying Small Cell Lung Cancer, Ovarian Cancer, Breast Cancer, so participants generally need a confirmed diagnosis.

What They're Measuring

The primary outcome measures will help determine the highest dose of the new drug that can be safely given and identify any serious side effects, which is crucial for understanding its potential benef The specific primary outcome measures are: Dose Escalation: Number of participants with Dose-limiting toxicities (DLT) during first cycle (28 days); To evaluate incidence of treatment emergent adverse events and laboratory abnormalities (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 (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 (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 (From baseline until end of study treatment or study completion (approximately 2 years)). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This trial is in Phase 2, which tests whether the treatment actually works against the target condition. Phase 2 trials involve 100-300 patients and continue to monitor safety while evaluating effectiveness. This phase often tests different dosages to find the optimal amount. About 33% of Phase 2 drugs advance to Phase 3. If successful, the treatment will move to large-scale Phase 3 trials needed for FDA approval.

Why This Trial Matters

This trial is important because it explores a new treatment option for patients with advanced cancers that have limited treatment alternatives, aiming to fill a gap in current therapies. Phase 2 success would typically lead to larger Phase 3 trials needed for regulatory approval. This research targets Small Cell Lung Cancer, Ovarian Cancer, Breast Cancer, where improved treatment options are needed.

Investor Insight

Pfizer is investigating PF-07104091, a novel drug, in a Phase 1/2a trial, indicating a significant investment in exploring new oncology treatments for common and difficult-to-treat cancers. Phase 2 trials have approximately a 15-20% chance of eventually gaining FDA approval.

Is This Trial Right for Me?

Ask your doctor about the specific drug combinations being tested and how they might affect your current treatments. Be prepared for regular clinic visits for drug administration, blood tests, and monitoring of your health and any side effects. The study involves dose escalation, meaning you might receive different doses of the medication as researchers learn more about its safety. The trial is being conducted at 20 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

Interventions

Primary Outcomes

Secondary Outcomes

Full Eligibility Criteria

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

Trial Locations

Frequently Asked Questions

What is clinical trial NCT04553133?

NCT04553133 is a Phase 2 INTERVENTIONAL study titled "PF-07104091 as a Single Agent and in Combination Therapy." It is currently active, not recruiting and is sponsored by Pfizer. The trial targets enrollment of 154 participants.

What conditions does NCT04553133 study?

This trial investigates treatments for Small Cell Lung Cancer, Ovarian Cancer, Breast Cancer. The primary condition under study is Small Cell Lung Cancer.

What treatments are being tested in NCT04553133?

The interventions being studied include: 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 will be administered orally

What does Phase 2 mean for NCT04553133?

Phase 2 trials test whether the treatment works for the intended condition. They involve 100-300 patients and continue to evaluate safety while measuring effectiveness.

What is the current status of NCT04553133?

This trial is currently "Active, Not Recruiting." It started on 2020-09-16. The estimated completion date is 2026-03-30.

Who is sponsoring NCT04553133?

NCT04553133 is sponsored by Pfizer. The sponsor is responsible for funding, designing, and overseeing the clinical trial.

How many people can participate in NCT04553133?

The trial aims to enroll 154 participants. The trial status is active, not recruiting.

How is NCT04553133 designed?

This is a interventional study, uses non_randomized allocation, follows a sequential design, employs none masking.

What are the primary outcomes being measured in NCT04553133?

The primary outcome measures are: Dose Escalation: Number of participants with Dose-limiting toxicities (DLT) during first cycle (28 days); To evaluate incidence of treatment emergent adverse events and laboratory abnormalities (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 (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 (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 (From baseline until end of study treatment or study completion (approximately 2 years)). These are the main endpoints researchers use to determine whether the treatment is effective.

Where is NCT04553133 being conducted?

This trial is being conducted at 20 sites, including Clive, Iowa; Des Moines, Iowa; Louisville, Kentucky; Boston, Massachusetts and 16 more sites (United States).

Where can I find official information about NCT04553133?

The official record for NCT04553133 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT04553133. This government database provides the most up-to-date and detailed information about the trial.

What is NCT04553133 testing in simple terms?

This trial tests a new drug, PF-07104091, alone or with other cancer treatments. It is for adults with advanced or metastatic breast, ovarian, or small cell lung cancer.

Why is this trial significant?

This trial is important because it explores a new treatment option for patients with advanced cancers that have limited treatment alternatives, aiming to fill a gap in current therapies.

What are the potential risks of participating in NCT04553133?

Common side effects may include nausea, fatigue, and changes in blood counts. Potential serious risks include heart problems, such as changes in heart rhythm, and blood clots. The drug may interact with other medications, so it's important to disclose all drugs you are taking. As with any clinical trial, participants are closely monitored and can withdraw at any time.

Should I consider participating in NCT04553133?

Ask your doctor about the specific drug combinations being tested and how they might affect your current treatments. Be prepared for regular clinic visits for drug administration, blood tests, and monitoring of your health and any side effects. The study involves dose escalation, meaning you might receive different doses of the medication as researchers learn more about its safety. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.

What does NCT04553133 signal from an investment perspective?

Pfizer is investigating PF-07104091, a novel drug, in a Phase 1/2a trial, indicating a significant investment in exploring new oncology treatments for common and difficult-to-treat cancers. This is a Phase 2 trial, which is focused on confirming efficacy before larger pivotal studies.

What happens if the treatment in this trial doesn't work?

Participants will receive increasing doses of the drug to find the safest and most effective dose. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.

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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.