337 Participants Needed

PF-07220060 for Solid Cancers

(CDK4i Trial)

Recruiting at 45 trial locations
PC
Overseen ByPfizer CT.gov Call Center
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: Pfizer
Must be taking: Endocrine therapy
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new drug, PF-07220060, in patients with metastatic breast cancer. It aims to find the best dose and see if the drug helps stop cancer growth when used alone or with other treatments.

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.

Who Is on the Research Team?

PC

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.
See 10 more

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.
See 7 more

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?
17Treatment groups
Experimental Treatment
Group I: 2E Combination Dose ExpansionExperimental Treatment2 Interventions
Group II: 2D Combination Dose ExpansionExperimental Treatment2 Interventions
Group III: 2C Combination Dose ExpansionExperimental Treatment2 Interventions
Group IV: 2B Combination Dose ExpansionExperimental Treatment2 Interventions
Group V: 2A Combination Dose ExpansionExperimental Treatment2 Interventions
Group VI: 1F Combination Dose FindingExperimental Treatment2 Interventions
Group VII: 1E DDI CohortExperimental Treatment2 Interventions
Group VIII: 1D Monotherapy Food EffectExperimental Treatment1 Intervention
Group IX: 1C Combination Dose Finding Arm 2Experimental Treatment2 Interventions
Group X: 1C Combination Dose Finding Arm 1Experimental Treatment2 Interventions
Group XI: 1B Combination Dose Finding Arm 2Experimental Treatment2 Interventions
Group XII: 1B Combination Dose Finding Arm 1Experimental Treatment2 Interventions
Group XIII: 1A Monotherapy Escalation Arm 5Experimental Treatment1 Intervention
Group XIV: 1A Monotherapy Escalation Arm 4Experimental Treatment1 Intervention
Group XV: 1A Monotherapy Escalation Arm 3Experimental Treatment1 Intervention
Group XVI: 1A Monotherapy Escalation Arm 2Experimental Treatment1 Intervention
Group XVII: 1A Monotherapy Escalation Arm 1Experimental Treatment1 Intervention

Find a Clinic Near You

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 profile image

Patrizia Cavazzoni

Pfizer

Chief Medical Officer

MD from McGill University

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