PF-07220060 for Solid Cancers

(CDK4i Trial)

Not currently recruiting at 54 trial locations

Overseen By Pfizer CT.gov Call Center

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Pfizer

Must be taking: Endocrine therapy

Must not be taking: CDK inhibitors, PI3K-mTOR inhibitors

Disqualifiers: CNS metastases, other active malignancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment, PF-07220060 (Atirmociclib), for various solid cancers, with a focus on breast cancer, prostate cancer, and other tumor types. The researchers aim to assess the safety and tolerability of this treatment when used alone or with other therapies like endocrine therapy, which reduces hormones, and to determine the optimal dose. Individuals with hormone receptor-positive breast cancer that no longer responds to current treatments, or those with prostate cancer resistant to standard therapies, may be suitable candidates. Participants should have tried other treatments that are no longer effective and must have specific types of measurable disease. As a Phase 2 trial, this research focuses on evaluating the treatment's effectiveness in an initial, smaller group of people.

Do I need to stop my current medications to join the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, you must be refractory (not responding) to or intolerant of existing therapies known to provide clinical benefit for your condition.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that PF-07220060, a new drug tested for treating solid cancers, generally maintains a good safety record. In studies, PF-07220060 alone has caused some side effects, but most were mild. Some patients experienced more serious issues like low blood platelets, particularly at higher doses.

When combined with fulvestrant, another cancer treatment, PF-07220060 was well-tolerated, with few blood-related side effects and rare need for dosage adjustments. Similarly, when paired with letrozole, patients handled the treatment well, and early data suggests it effectively fights cancer.

PF-07220060 combined with enzalutamide also maintained a good safety record. Most patients managed the combination well, and it showed promise in treating cancer. Overall, while some risks and side effects exist, the treatment has been generally well-received in previous studies. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about PF-07220060 because it targets solid cancer cells in a novel way, potentially offering new hope for patients. Unlike many standard treatments that focus on killing rapidly dividing cells, PF-07220060 works by inhibiting specific proteins involved in cancer cell growth and survival. This unique mechanism could mean fewer side effects and more effective targeting of cancer cells. Additionally, PF-07220060 is being tested both alone and in combination with other drugs like fulvestrant, letrozole, and enzalutamide, which could enhance its effectiveness and offer tailored treatment options for different cancer types.

What evidence suggests that PF-07220060 could be an effective treatment for solid cancers?

Studies suggest that PF-07220060, a drug targeting specific cancer cell growth, shows promise against certain solid tumors. In this trial, participants may receive PF-07220060 with letrozole, which has achieved a 58.8% overall response rate and a 94.1% clinical benefit rate in patients with hormone receptor-positive and HER2-negative breast cancer. Another trial arm involves PF-07220060 combined with fulvestrant, which has also shown positive effects, with patients experiencing good survival outcomes. Additionally, the combination with enzalutamide is being tested and is well-tolerated, showing strong responses in the same type of breast cancer. Although still under study, these early results highlight the potential effectiveness of PF-07220060 in different treatment combinations within this trial. ^{4 6 7 8 9}

Who Is on the Research Team?

Pfizer CT.gov Call Center

Principal Investigator

Pfizer

Are You a Good Fit for This Trial?

This trial is for adults with advanced solid tumors, including specific breast and prostate cancers, who have not responded to existing therapies. Participants must have a certain level of physical fitness (ECOG PS 0 or 1) and adequate organ function. They should not have received cancer treatment within the last 2 weeks or be pregnant/breastfeeding.

Inclusion Criteria

My breast cancer is HR+ and HER2- and does not respond to hormone therapy.

My breast cancer is resistant to treatment and is both HR and HER2 positive.

My kidney, liver, and bone marrow are functioning well.

Exclusion Criteria

I do not have active brain metastases or related conditions.

I haven't had cancer treatment in the last 2 weeks.

My cancer returned while on or soon after aromatase inhibitor treatment. I've also had CDK4/6 inhibitor therapy.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Part 1A involves single escalating doses of PF-07220060 to determine the maximum tolerated dose (MTD) and select the recommended dose for expansion.

28 days per cycle, up to 24 months

Weekly during Cycle 1 and 2, then every 28 days

Combination Therapy

Part 1B and Part 1C involve PF-07220060 administered in combination with endocrine therapies (letrozole and fulvestrant).

28 days per cycle, up to 24 months

Weekly during Cycle 1 and 2, then every 28 days

Dose Expansion

Part 2 includes dose expansion cohorts evaluating PF-07220060 in combination with endocrine therapy or enzalutamide.

28 days per cycle, up to 24 months

Weekly during Cycle 1 and 2, then every 28 days

Follow-up

Participants are monitored for safety and effectiveness after treatment.

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• PF-07220060

Trial Overview The study tests PF-07220060's safety and effects both alone and with endocrine therapy in multiple doses. It includes patients with various cancers such as lung adenocarcinoma, colorectal cancer, liposarcoma, prostate cancer, and breast cancer.

How Is the Trial Designed?

Group I: 2E Combination Dose Expansion Experimental Treatment 2 Interventions

PF-07220060 Monotherapy OR PF-07220060 plus fulvestrant combination therapy

Group II: 2D Combination Dose Expansion Experimental Treatment 2 Interventions

PF-07220060 with enzalutamide Combination Expansion

Group III: 2C Combination Dose Expansion Experimental Treatment 2 Interventions

PF-07220060 with fulvestrant Combination Expansion

Group IV: 2B Combination Dose Expansion Experimental Treatment 2 Interventions

PF-07220060 with Letrozole Combination Expansion

Group V: 2A Combination Dose Expansion Experimental Treatment 2 Interventions

PF-07220060 with fulvestrant combination dose expansion

Group VI: 1F Combination Dose Finding Experimental Treatment 2 Interventions

PF-07220060 with Enzalutamide Escalation

Group VII: 1E DDI Cohort Experimental Treatment 2 Interventions

PF-07220060 DDI with Midazolam

Group VIII: 1D Monotherapy Food Effect Experimental Treatment 1 Intervention

PF-07220060 Monotherapy Food Effect

Group IX: 1C Combination Dose Finding Arm 2 Experimental Treatment 2 Interventions

PF-07220060 with Fulvestrant Combination Escalation

Group X: 1C Combination Dose Finding Arm 1 Experimental Treatment 2 Interventions

PF-07220060 with Fulvestrant Combination Escalation

Group XI: 1B Combination Dose Finding Arm 2 Experimental Treatment 2 Interventions

PF-07220060 with Letrozole Combination Escalation

Group XII: 1B Combination Dose Finding Arm 1 Experimental Treatment 2 Interventions

PF-07220060 with Letrozole combination Escalation

Group XIII: 1A Monotherapy Escalation Arm 5 Experimental Treatment 1 Intervention

PF-07220060 Monotherapy Escalation

Group XIV: 1A Monotherapy Escalation Arm 4 Experimental Treatment 1 Intervention

PF-07220060 Monotherapy Escalation

Group XV: 1A Monotherapy Escalation Arm 3 Experimental Treatment 1 Intervention

PF-07220060 Monotherapy Escalation

Group XVI: 1A Monotherapy Escalation Arm 2 Experimental Treatment 1 Intervention

PF-07220060 Monotherapy Escalation

Group XVII: 1A Monotherapy Escalation Arm 1 Experimental Treatment 1 Intervention

PF-07220060 Monotherapy Escalation

Who Is Running the Clinical Trial?

Pfizer

Lead Sponsor

Trials

4,712

Recruited

50,980,000+

Known For

Vaccine Innovations

Top Products

Viagra, Zoloft, Lipitor, Prevnar 13

Albert Bourla

Pfizer

Chief Executive Officer since 2019

PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki

Patrizia Cavazzoni

Pfizer

Chief Medical Officer

MD from McGill University

Citations

1. pfizeroncologydevelopment.com pfizeroncologydevelopment.com/clinical_trial/NCT04557449

Atirmociclib (PF-07220060) Atirmociclib | PF-07220060 is an investigational compound. Its safety and efficacy have not been established. A PHASE 1/2A STUDY EVALUATING THE SAFETY, ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05262400

NCT05262400 | A Study to Learn About the ... The purpose of this clinical trial is to learn about the safety and effects of the study medicine (called PF-07220060 and PF-07104091) in people with breast ...

3. aacrjournals.org aacrjournals.org/clincancerres/article/31/12_Supplement/P5-07-28/752659/Abstract-P5-07-28-The-next-generation-CDK4

The next-generation CDK4-selective inhibitor atirmociclib (PF ... Here, we present the efficacy and safety results from an expansion cohort in the phase 1/2a study of atirmociclib in combination with letrozole ...

4. ascopubs.org ascopubs.org/doi/10.1200/JCO.2023.41.16_suppl.3009

mBC who progressed on prior CDK4/6 inhibitors ... Median progression-free survival was 24.7 wks (95% CI: 23.1, 47.4). At data cutoff, 8/26 (30.8%) pts with mBC continued PF-07220060 + ET without ...

5. onclive.com onclive.com/view/atirmociclib-plus-letrozole-demonstrates-preliminary-efficacy-and-safety-in-hr-her2-negative-metastatic-breast-cancer

Atirmociclib Plus Letrozole Demonstrates Preliminary ... Atirmociclib combined with letrozole showed a 58.8% overall response rate and 94.1% clinical benefit rate in HR-positive, HER2-negative ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT04557449

Study to Test the Safety and Tolerability of PF-07220060 in ... This is a Phase 1/2A, open label, multicenter, nonrandomized, multiple dose, safety, tolerability, pharmacokinetic and pharmacodynamic study of PF-07220060

7. ascopubs.org ascopubs.org/doi/10.1200/JCO.2024.42.16_suppl.3108

First-in-human phase 1/2a study of the first-in-class, next- ... Herein, we report updated safety data for PF-07220060 + ET in pts with HR+/HER2− advanced/metastatic breast cancer (mBC), including extended ...

8. researchgate.net researchgate.net/publication/381430668_First-in-human_phase_12a_study_of_the_first-in-class_next-generation_CDK4-selective_inhibitor_PF-07220060_endocrine_therapy_ET_Updated_safety_data_in_patients_with_HRHER2-_mBC

Updated safety data in patients with HR+/HER2− mBC Background: PF-07220060 is a novel, highly selective CDK4 inhibitor with significant CDK6 sparing. Preliminary data have been reported for ...

9. asco.org asco.org/abstracts-presentations/ABSTRACT400394

mBC who progressed on prior CDK4/6 inhibitors and ... A similar safety profile was seen in monotherapy. Dose-limiting toxicities occurred at PF-07220060 500 mg monotherapy BID (n=2 G3 thrombocytopenia) and at ...