PF-07220060 for Solid Cancers

(CDK4i Trial)

Recruiting in Palo Alto (17 mi)

+45 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Recruiting

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

Trial Summary

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.

Eligibility Criteria

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.

Trial Timeline

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

Treatment Details

Interventions

• PF-07220060 (Other)

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.

Participant Groups

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

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Sarah Cannon Research Institute - Pharmacy Nashville, TN

Tennessee Oncology, PLLC Franklin, TN

Yale-New Haven Hospital-Yale Cancer Center New Haven, CT

SCRI Oncology Partners Nashville, TN

More Trial Locations

Who Is Running the Clinical Trial?

Pfizer Lead Sponsor

References