Overview

Study to Assess the Safety and Tolerability of PF-07220060 in Combination With PF-07104091 in Participants With Breast Cancers or Solid Tumors and to Assess the Safety and Tolerability of PF-07220060 and PF-07104091 in Combination With Endocrine The

Status:
Not yet recruiting
Trial end date:
2027-11-03
Target enrollment:
0
Participant gender:
All
Summary
To assess the safety and tolerability of increasing doses of PF-07220060 in combination with PF-07104091 and to estimate the Maximum Tolerated Dose (MTD) and/or select the Recommended dose for expansion (RDE) for PF-07220060 in combination with PF-07104091 in participants with breast cancers or solid tumors and to assess the safety and tolerability of the RDE of PF-07220060 and PF-07104091 in combination with Endocrine Therapy in participants with breast cancer.
Phase:
Phase 1/Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Pfizer
Treatments:
Fulvestrant
Letrozole
Criteria
Inclusion Criteria

- Part 1: Breast Cancer (BC)

- HR+, HER2- BC

- Refractory HR-positive/HER2-positive BC

- Part 1: Solid Tumors other than BC

- Part 2:

- HR-positive/HER2-negative BC

- Lesion:

- Part 1: evaluable lesion (including skin or bone lesion only)

- Part 2: measurable lesion per RECIST v1.1

- Prior systemic Treatment

- Part 1: HR-positive/HER2-negative BC

- At least 1 line of SOC, including CDK4/6 inhibitor therapy and Endocrine Therapy,
for advanced or metastatic disease.

- Prior chemotherapy in the metastatic setting is allowed.

- Part 1: HR-positive/HER2-positive BC

- At least 1 prior treatment of approved HER2 targeting therapy.

- Part 1: Solid Tumors other than BC

- Participants with no standard therapy available or for which no local regulatory
approved standard therapy is available that would confer significant clinical
benefit in the medical judgement of the investigator.

- Part 2A: At least 1 prior systemic therapy for advanced or metastatic disease,
including CDK4/6 inhibitor treatment and ET.

- Parts 2A and 2B: At least 1 prior endocrine therapy for advanced or metastatic
disease.

- Part 2B: Up to 1 prior line of chemotherapy for advanced/metastatic disease is
allowed.

- General Inclusion Criteria

- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1

- Adequate renal, liver, and bone marrow function

- Resolved acute effects of any prior therapy to baseline severity

Exclusion Criteria:

- All Study Parts: Permanent treatment discontinuation from prior CDK 4 and/or CDK2
inhibitor due to treatment related toxicity.

- Part 2B: Prior treatment with any CDK 4/6 inhibitor, or fulvestrant, or everolimus.

- Parts 2B and 2C: Prior treatment with any CDK4/6 inhibitor for advanced disease.

- Part 2C: Prior neoadjuvant or adjuvant treatment with a nonsteroidal aromatase
inhibitor AI (ie, anastrozole or letrozole) with disease recurrence while on or within
12 months of completing treatment.

- Prior irradiation to >25% of the bone marrow

- Current use of drugs which have a risk for QTc prolongation

- Current use or anticipated need for food or drugs that are known strong CYP3A4/5,
strong UGT2B7 or UGT1A9 inhibitors or inducers

- Participation in other studies involving investigational drug(s) within 4 weeks prior
to study entry

- Participants with any other active malignancy within 3 years prior to enrollment
except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in
situ of the cervix, Bowen's disease

- Major surgery within 4 weeks prior to study entry

- Radiation therapy within 4 weeks prior to study entry.

- Clinically important hypertension

- Known or suspected hypersensitivity to PF-07220060, PF-07104091, letrozole,
fulvestrant, or goserelin (or equivalent to induce chemical menopause if applicable)

- Known abnormalities in coagulation. Anticoagulation with subcutaneous heparin or
prophylactic doses of anticoagulant are allowed

- Known active uncontrolled or symptomatic central nervous system (CNS) metastases

- Active inflammatory GI disease

- Current use or anticipated need for Proton Pump Inhibitors (PPI) within 14 days prior
to first dose of the study intervention

- Previous high-dose chemotherapy requiring stem cell rescue

- Participants with active, uncontrolled bacterial, fungal, or viral infection,
including hepatitis B virus (HBV), hepatitis C virus (HCV), and known human
immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS) related
illness

- Other protocol specific exclusion criteria may apply