What side effects are associated with this type of intervention?

Common treatments for Small Cell Lung Cancer (SCLC) include chemotherapy, immunotherapy, and small molecule inhibitors. Chemotherapy agents like cisplatin, etoposide, and carboplatin often cause side effects such as nausea, vomiting, hair loss, fatigue, and increased risk of infection due to bone marrow suppression. Immunotherapy, including PD-1/PD-L1 inhibitors, can lead to immune-related adverse events like colitis, pneumonitis, and dermatitis. Small molecule inhibitors, similar to PF-07104091, may cause side effects such as diarrhea, liver enzyme abnormalities, fatigue, and hypertension. Patients should discuss these potential side effects with their healthcare provider to manage and mitigate them effectively.

What prior FDA approvals exist?

The FDA has approved several treatments for Small Cell Lung Cancer (SCLC), including chemotherapeutic agents and targeted therapies. Notably, trilaciclib, a CDK4/6 inhibitor, has been approved to reduce chemotherapy-induced myelosuppression in SCLC patients. Additionally, immune checkpoint inhibitors such as atezolizumab and nivolumab have been approved for extensive-stage SCLC. These treatments, while not small molecule inhibitors like PF-07104091, represent significant advancements in targeting specific pathways involved in cancer cell proliferation and survival.

What other types of research exist?

Promising novel alternatives to PF-07104091 for SCLC patients include: 1) A novel broad-spectrum neuropeptide antagonist that targets chemoresistant CD133+ cancer stem-like cells, showing growth inhibitory and proapoptotic effects. 2) CGP41251, a selective protein kinase C inhibitor, which induces G2/M cell cycle arrest and decreases PKC activity, demonstrating antitumor activity in non-small cell lung cancer. 3) MT477, a quinoline derivative that inhibits the Ras molecular pathway and PKC activity, showing significant in vivo anti-tumor activity in lung carcinoma models.

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PF-07104091 for Breast Cancer

Phase 1 & 2

Waitlist Available

Research Sponsored by Pfizer

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participants with cytological diagnosis of advanced/metastatic SCLC

Participants with locally recurrent/advanced or metastatic TNBC who have received up to 2 prior lines of chemotherapy in the advanced or metastatic setting

Must not have

Known abnormalities in coagulation such as bleeding diathesis, or treatment with anticoagulants precluding intramuscular injections of goserelin (if applicable)

Participants with advanced/metastatic, symptomatic, visceral spread, that are at risk of life threatening complications in the short term

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from baseline and every 8 weeks through disease progression or study completion (approximately 2 years)

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new drug called PF-07104091 to see if it is safe and well-tolerated in adults with various advanced cancers. The goal is to find the highest dose that can be taken without severe side effects and determine the best dose for future studies.

Who is the study for?

This trial is for adults with certain advanced cancers: small cell lung cancer (SCLC), ovarian, or breast cancer. Participants must have a performance status of 0 or 1, indicating they are fully active or restricted in physically strenuous activity but can do light work. They should have received prior treatments specific to their cancer type and must not have any serious heart conditions, uncontrolled infections, recent major surgeries, other active malignancies within the last three years, or be pregnant.

What is being tested?

The trial tests different doses and combinations of PF-07104091 to find the safest and most effective dose for treating advanced cancers. It includes monotherapy (PF-07104091 alone) and combination therapies with drugs like fulvestrant and palbociclib. The goal is to determine the maximum tolerated dose (MTD) and/or recommend a Phase 2 dose (RP2D).

What are the potential side effects?

Potential side effects may include typical reactions from cancer medications such as nausea, fatigue, blood count changes leading to increased infection risk or bleeding tendencies. Specific side effects related to PF-07104091 aren't detailed but could align with common chemotherapy-related adverse events.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer is small cell lung cancer and has spread.

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I have TNBC and received up to 2 chemotherapy treatments for advanced cancer.

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My breast cancer is HR-positive, HER2-negative, and has spread.

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My lung cancer has spread to other parts of my body.

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I have ovarian, fallopian tube, or peritoneal cancer that didn't respond to platinum-based treatment.

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I am fully active or restricted in physically strenuous activity but can do light work.

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My breast cancer is HR-positive, HER2-negative, and I've had specific previous treatments.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I cannot take certain injections due to bleeding disorders or being on blood thinners.

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My cancer has spread to other organs and is causing symptoms that could be life-threatening soon.

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I am using or might need drugs sensitive to UGT1A1 with strict dosage requirements.

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I currently have COVID-19.

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I have not had serious heart or blood clot issues in the last 6 months.

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I have brain metastases and need steroids for symptoms.

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I do not have any active, uncontrolled infections including HBV, HCV, HIV, or AIDS.

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I have not had major surgery in the last 3 weeks.

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My heart's electrical activity is normal as per my last ECG.

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I haven't had any cancer treatments in the last 4 weeks.

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I have had high dose chemotherapy with stem cell support.

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I am not taking blood thinners like warfarin or Xarelto.

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I have not had any other cancer in the last 3 years.

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More than a quarter of my bone marrow has been exposed to radiation.

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My high blood pressure cannot be managed with medication.

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I have not had radiation therapy in the last 3 weeks.

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I am not using, nor do I plan to use, strong drugs that affect liver enzymes.

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I have ongoing stomach or bowel issues, including surgeries.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from baseline and every 8 weeks through disease progression or study completion (approximately 2 years)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from baseline and every 8 weeks through disease progression or study completion (approximately 2 years)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline and every 8 weeks through disease progression or study completion (approximately 2 years) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Dose Escalation: Number of participants with Dose-limiting toxicities (DLT) during first cycle

Evaluate blood pressure that is out of normal range and changes in blood pressure as compared to baseline

Evaluate pulse rate that is out of normal range and changes in pulse rate as compared to baseline

+3 more

Secondary study objectives

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

Area under the curve of PF-07104091 with or without food

Maximum plasma concentration (Cmax) of PF-07104091 after a single dose and multiple dose

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

7Treatment groups

Experimental Treatment

Group I: PF-07104091 monotherapy dose expansion (ovarian)Experimental Treatment1 Intervention

PF-07104091 monotherapy dose expansion (ovarian)

Group II: PF-07104091 monotherapy dose expansion (SCLC)Experimental Treatment1 Intervention

PF-07104091 monotherapy dose expansion (SCLC)

Group III: PF-07104091 + palbociclib + letrozoleExperimental Treatment1 Intervention

CDK2 + palbociclib + letrozole

Group IV: PF-07104091 + palbociclib + fulvestrantExperimental Treatment1 Intervention

CDK2 + palbociclib + fulvestrant

Group V: PF-07104091 + fulvestrant (post CDK4/6) dose expansionExperimental Treatment1 Intervention

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

Group VI: PF-07104091 + fulvestrant (post CDK 4/6) dose escalationExperimental Treatment1 Intervention

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

Group VII: PF-07104091Experimental Treatment1 Intervention

CDK2 monotherapy dose escalation

0 / 25Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Small Cell Lung Cancer (SCLC) include chemotherapy, immunotherapy, and small-molecule inhibitors. Chemotherapy, often using etoposide combined with either cisplatin or carboplatin, works by damaging the DNA of rapidly dividing cancer cells, leading to cell death. Immunotherapy, such as anti-PD-1 or anti-PD-L1 therapies, enhances the body's immune response against cancer cells. Small-molecule inhibitors, like those being studied in trials such as PF-07104091, target specific proteins or pathways critical for cancer cell proliferation and survival, such as tyrosine kinases. These treatments are crucial for SCLC patients as they address the aggressive nature of the disease and its tendency to spread rapidly, thereby improving survival rates and quality of life.

Caspase-9b Interacts Directly with cIAP1 to Drive Agonist-Independent Activation of NF-κB and Lung Tumorigenesis.Drug resistance in lung cancer.A review of small-molecule epidermal growth factor receptor-specific tyrosine kinase inhibitors in development for non-small cell lung cancer.