About the study

This is a Phase 1, open label, multicenter, nonrandomized, multiple dose, safety, tolerability, pharmacokinetic and pharmacodynamic study of PF-07220060 administered as a single agent and then in combination with endocrine therapy. In Part 1A, single escalating doses of PF-07220060 alone will be administered to determine the maximum tolerated dose (MTD) and select the recommended phase 2 dose (RP2D). In Part 1B and Part 1C, PF-07220060 will be administered in combination with 1 of 2 endocrine therapies (letrozole and fulvestrant, respectively). In Part 1D, food effect assessment of PF-07220060 at the RP2D dose level from the Part 1A will be conducted. Part 1B and Part 1C may commence at MTD or before reaching the MTD at a dose level in Part 1A. Part 2B and Part 2C are expansion for combination therapy of PF-07220060 with letrozole and fulvestrant, respectively.

Who can take part?

You may be eligible to participate in the study if you meet the following criteria:

Inclusion criteria

1. Part 1: Breast Cancer (BC)
2. Refractory Hormone Receptor Positive (HR+), Human Epidermal Growth Factor Receptor 2 Negative (HER2-) BC
3. Part 1A/Part 1D also include: Refractory HR-positive/HER2-positive BC
4. Part 1: Tumors other than BC (Part 1A/Part 1D): NSCLC, prostate, CRC, liposarcoma, or tumors with previously confirmed CDK4 or CCND1 amplification according to local standard tests
5. Part 2:
6. HR-positive/HER2-negative BC
7. Patients who are either postmenopausal women or pre/peri-menopausal (Part 2C only)
8. Lesion:
9. Part 1: evaluable lesion (including skin or bone lesion only)
10. Part 2: measurable lesion per RECIST v1.1
11. Prior systemic Treatment
12. Part 1: HR-positive/HER2-negative BC
13. At least 1 line of SOC, including CD4/6 inhibitor therapy for advanced or metastatic disease, or if CDK4/6 inhibitors are not considered appropriate in the opinion of the investigator
14. At least 1 line of anti-endocrine in countries without CDK4/6 inhibitor approval or reimbursement, for advanced or metastatic disease
15. HR-positive/HER2-positive BC (Parts 1A/1D): at least 1 prior treatment of approved HER2 targeting therapy
16. Tumors other than BC (Parts 1A/1D): tumor that is resistant to at least 2 lines of SOC for advanced or recurrent disease or for which no standard therapy is available
17. Part 2B: participants who have not received any prior systemic anti-cancer therapies for advanced/metastatic BC
18. Part 2C:
19. Progressed during treatment or within 12 months of completion of adjuvant therapy with an aromatase inhibitor if postmenopausal, or tamoxifen if pre or perimenopausal, or
20. Progressed while on or within 1 month after the endo the prior aromatase inhibitor therapy for advanced/metastatic BC if postmenopausal or prior endocrine treatment for advanced/metastatic BC if pre or perimenopausal
21. One previous line of chemotherapy for advanced/metastatic disease is allowed in addition to endocrine therapy General

For a full list of inclusion/exclusion criteria, please visit ClinicalTrials.gov

Study locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to apply

Determine if a study site for this clinical trial is near you. Contact the study to apply.