Study on the Safety and Effectiveness of PF-07104091 Alone or with Fulvestrant, Letrozole, and Palbociclib for Patients with Advanced Breast, Ovarian, or Lung Cancer

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What is this study about?

This clinical trial is focused on studying the effects of a new treatment for several types of cancer, including Breast Cancer, Ovarian Cancer, and Small Cell Lung Cancer (SCLC). The study will explore the use of a new medication known by its code name PF-07104091, both as a standalone treatment and in combination with other therapies. The combination therapies include Fulvestrant, Letrozole, and Palbociclib, which are existing treatments used in managing certain types of breast cancer.

The purpose of the study is to evaluate the safety and effectiveness of PF-07104091 in patients with advanced or metastatic forms of these cancers. The study will be conducted in phases, starting with determining the appropriate dosage of PF-07104091 when used alone. Subsequent phases will assess the safety and potential benefits of combining PF-07104091 with other cancer treatments. Patients will receive either the new treatment or a placebo, and their health will be monitored to understand how the treatment affects their cancer and overall well-being.

Participants in the study will take the medication orally, in the form of capsules or tablets, or receive it through an injection, depending on the specific treatment plan. The study aims to gather information on how the body processes the medication and its impact on tumor growth. This research is crucial for developing new treatment options for patients with these challenging cancer types.

1 initial assessment

Upon joining the study, an initial assessment is conducted to ensure eligibility. This includes checking age, kidney and liver function, and overall health status.

Participants must have resolved any acute effects from previous treatments and be willing to comply with all study procedures.

2 treatment phase 1

In the first part of the study, participants receive the investigational drug PF-07104091 to evaluate its safety and tolerability.

The dosage is adjusted to find the most suitable amount that can be safely administered.

3 combination therapy

Participants may receive PF-07104091 in combination with other medications such as fulvestrant or letrozole to assess the combined effect.

The combination aims to determine the best dosage and evaluate any potential side effects.

4 monitoring and follow-up

Throughout the study, regular monitoring is conducted to track the participant’s response to the treatment.

This includes frequent health check-ups, laboratory tests, and assessments of any side effects.

5 final evaluation

At the end of the study, a comprehensive evaluation is performed to assess the overall effectiveness and safety of the treatment.

Participants are informed about the study results and any further steps if necessary.

Who Can Join the Study?

Participants must be 18 years or older.
Participants must have adequate kidney function. This means their kidneys are working well enough, as measured by a test called creatinine clearance.
Participants must have adequate liver function. This includes specific blood tests:
- Total serum bilirubin should be less than 1.5 times the normal limit, unless they have a condition called Gilbert syndrome.
- AST and ALT, which are liver enzymes, should be less than 2.5 times the normal limit, or less than 5 times if the liver is affected by the tumor.
- Alkaline phosphatase should be less than 2.5 times the normal limit, or less than 5 times if there is cancer in the bones.
Any side effects from previous treatments should be resolved to a mild level or to the level they were before treatment, except for effects that are not considered a safety risk by the study doctor.
Participants must be willing and able to attend all scheduled visits, follow the treatment plan, and complete all required tests and procedures.
Participants must be able to provide informed consent, which means they understand the study and agree to participate.
For Part 1 of the study:
- Participants with HR-positive HER2-negative advanced or metastatic breast cancer who have had at least two previous treatments.
- Participants with locally recurrent or advanced metastatic triple-negative breast cancer (TNBC) who have had up to three previous chemotherapy treatments.
- Participants with advanced platinum-resistant epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer who have had at least one previous treatment with a platinum-based drug.
For Part 1A only:
- Participants with a diagnosis of advanced or metastatic small cell lung cancer (SCLC).
- Participants with a diagnosis of advanced or metastatic non-small cell lung cancer (NSCLC).
- Participants with HR-positive HER2-negative advanced or metastatic breast cancer who have had at least one previous treatment.
For Part 2A:
- Participants with a diagnosis of advanced or metastatic small cell lung cancer (SCLC).
For Part 2B:
- Participants with advanced platinum-resistant epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer.
For Part 2C:
- Participants with HR-positive HER2-negative advanced or metastatic breast cancer who have previously received endocrine therapy and a CDK4/6 inhibitor.
Participants must have at least one measurable lesion that has not been treated with radiation, as defined by specific criteria (RECIST version 1.1).
Participants must have an ECOG performance status of 0 or 1, which means they are fully active or have some symptoms but do not need bed rest during the day.
Participants must have adequate bone marrow function, which includes:
- Absolute neutrophil count (ANC) of at least 1,500 per mm³ or 1.5 x 10⁹/L.
- Platelet count of at least 100,000 per mm³ or 100 x 10⁹/L.
- Hemoglobin level of at least 9 g/dL.

Who Cannot Join the Study?

Patients who have a different type of cancer than those specified in the study cannot participate.
Patients who are not within the specified age range for the study cannot participate.
Patients who are not able to follow the study procedures or take the study medication as required cannot participate.
Patients who have other serious health conditions that might interfere with the study cannot participate.
Patients who are pregnant or breastfeeding cannot participate.
Patients who have participated in another clinical trial recently may not be eligible.
Patients who have allergies or adverse reactions to the study medication or similar drugs cannot participate.
Patients who are unable to provide informed consent cannot participate.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Complex Oncological Center Plovdiv EOOD	Plovdiv	Bulgaria

Trial status

Country	Status	Recruitment Start
Bulgaria	Not recruiting	10.04.2023

Trial locations

Investigated drugs:

PF-07104091 is an experimental medication being tested to see how safe and tolerable it is for patients with certain types of advanced cancers. These include hormone receptor-positive, HER2-negative breast cancer, triple-negative breast cancer, and some types of lung and ovarian cancers. The study aims to find the best dose of this medication when used alone and to see how it affects the body and the cancer.

Fulvestrant is a type of hormone therapy used in this study to treat certain breast cancers. It works by blocking the effects of estrogen, a hormone that can help some breast cancers grow. In this trial, it is used in combination with other treatments to see if it can help improve outcomes for patients with advanced breast cancer.

Letrozole is another hormone therapy included in the study. It is used to treat breast cancer by lowering estrogen levels in the body, which can slow or stop the growth of some breast cancers. The trial is testing how well it works when combined with other treatments for advanced breast cancer.

Palbociclib is a medication that helps stop cancer cells from growing by interfering with their ability to divide. It is used in combination with hormone therapies like fulvestrant or letrozole in this study to see if it can improve treatment outcomes for patients with advanced breast cancer.

Investigated diseases:

Breast Cancer – Breast cancer is a disease where cells in the breast grow uncontrollably. It typically begins in the ducts or lobules of the breast. As it progresses, it can spread to nearby tissues and lymph nodes. The disease may further advance to other parts of the body through the bloodstream or lymphatic system. The growth of cancer cells can form a lump or mass in the breast. Changes in breast shape, size, or skin texture may occur as the disease develops.

Ovarian Cancer – Ovarian cancer originates in the ovaries, which are part of the female reproductive system. It often begins in the outer layer of the ovaries and can spread to the pelvis and abdomen. As the disease progresses, it may affect other organs in the abdominal cavity. The cancer cells can form tumors, leading to swelling and pain. Symptoms may include bloating, pelvic discomfort, and changes in bowel habits. The disease can advance silently, often being detected at a later stage.

Small Cell Lung Cancer (SCLC) – Small cell lung cancer is a fast-growing type of lung cancer that primarily arises in the bronchi. It is characterized by small, round cancer cells that multiply quickly. The disease often spreads rapidly to other parts of the body, including the lymph nodes and distant organs. As it progresses, it can cause symptoms such as coughing, chest pain, and difficulty breathing. The rapid growth of cancer cells can lead to the formation of large tumors. SCLC is often associated with smoking and is more aggressive than other types of lung cancer.

Triple-Negative Breast Cancer (TNBC) – Triple-negative breast cancer is a subtype of breast cancer that lacks three common receptors known to fuel most breast cancer growth. It is characterized by the absence of estrogen receptors, progesterone receptors, and excess HER2 protein. This type of cancer tends to grow and spread more quickly than other forms of breast cancer. It often affects younger women and is more common in certain ethnic groups. As the disease progresses, it can spread to other parts of the body. Symptoms may include a lump in the breast, changes in breast shape, and skin dimpling.

Non-Small Cell Lung Cancer (NSCLC) – Non-small cell lung cancer is the most common type of lung cancer, accounting for a majority of cases. It typically starts in the epithelial cells lining the lungs. The disease progresses by forming tumors that can invade nearby tissues and spread to other parts of the body. Symptoms may include persistent cough, chest pain, and shortness of breath. As the cancer advances, it can affect the lymph nodes and distant organs. NSCLC grows more slowly than small cell lung cancer but can still be aggressive.

Trial ID:

2024-515492-34-00

Protocol code:

C4161001

Trial Phase:

Human Pharmacology (Phase I) – Other

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Study on the Safety and Effectiveness of PF-07104091 Alone or with Fulvestrant, Letrozole, and Palbociclib for Patients with Advanced Breast, Ovarian, or Lung Cancer

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?