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Study to Test the Safety and Tolerability of PF-07220060 in Participants With Advance Solid Tumors

Trial Status: Active

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). Part 1B and Part 1C may be enrolled and conducted in parallel at the completion of Part 1A.

Inclusion Criteria

  • Disease Characteristics - Breast Cancer (Part 1A, Part 1B and Part 1C)
  • Refractory Hormone Receptor Positive (HR+), Human Epidermal Growth Factor Receptor 2 Negative (HER2-) breast cancer (2L + with prior CDK 4/6) locally advance or metastatic breast cancer. Participants should have received at least 1 line of SOC, including CDK4/6 inhibitor therapy, or at least 1 line of anti-endocrine therapy in countries without CDK4/6 inhibitor approval or reimbursement, for advanced or metastatic disease
  • Part 1A only: Refractory HR-positive (HR+), Human Epidermal Growth Factor Receptor 2 Positive (HER2+) breast cancer
  • Evaluable lesion (including skin or bone lesion only)
  • Disease Characteristics - Part 1A: Tumors other than BC
  • Participants with advanced or metastatic disease
  • Participants with histological or cytological diagnosis of adenocarcinoma of NSCLC, prostate, CRC, liposarcoma, or tumors with previously confirmed CDK4 or CCND1 amplification according to local standard tests, that is resistant to at least 2 lines of standard systemic therapy for advanced or recurrent disease or for which no standard therapy is available
  • Participants must not be eligible to undergo therapy with curative intent (surgery or radiation therapy with or without chemotherapy General Inclusion Criteria
  • All participants must be refractory to or intolerant of existing therapies known to provide clinical benefit for their condition.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1
  • Adequate renal, liver, and bone marrow function

Exclusion Criteria

  • Known active uncontrolled or symptomatic Central Nervous System (CNS) metastases carcinomatous meningitis, or leptomeningeal disease
  • Other active malignancy within 3 years prior to randomization, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ
  • Major surgery or radiation within 4 weeks prior to study intervention
  • Last anti-cancer treatment within 2 weeks prior to study intervention
  • Participation in other studies involving investigational drug(s) within 4 weeks prior to study entry
  • Pregnant or breastfeeding female participant
  • Active inflammatory gastrointestinal (GI) disease, known diverticular disease or previous gastric resection or lap band surgery including impairment of gastrointestinal function or GI disease

Connecticut

New Haven
Yale University
Status: ACTIVE

Massachusetts

Boston
Brigham and Women's Hospital
Status: ACTIVE
Dana-Farber Cancer Institute
Status: ACTIVE

Texas

Houston
M D Anderson Cancer Center
Status: ACTIVE

Trial Phase Phase I

Trial Type Treatment

Lead Organization
Pfizer Inc

  • Primary ID C4391001
  • Secondary IDs NCI-2020-10085, 2020-002938-33
  • Clinicaltrials.gov ID NCT04557449