PF-07220060 MONOHYDRATE for Breast cancer (HR-positive HER2-negative) | Advanced solid tumors

Inclusion criteria

• {"criterion_text":"- Male and female participants ≥ 18 years of age at Visit 1."}
• {"criterion_text":"- Histological or cytological diagnosis of locally advanced or metastatic solid tumor/diagnosis which is unresectable."}
• {"criterion_text":"- Evaluable lesion (including skin or bone lesion only, Part 1)."}
• {"criterion_text":"- Participants entering the study in the expansion cohort have at least 1 measurable lesion as defined by RECIST (version 1.1) that has not been previously irradiated."}
• {"criterion_text":"- Cancer type: • HR-positive HER2negative tumor (Part 1 and Part 2) • HR-positive HER2-positive tumor (Part 1) • Advanced solid tumor or metastatic disease (Part 1) • ECOG PS 0 or 1."}

Exclusion criteria

• {"criterion_text":"- Prior/concomitant treatment as follows: • prior treatment with any CDK 4/6 inhibitor, or fulvestrant, or everolimus, or any agent whose mechanism of action is to inhibit the PI3K-mTOR pathway (Part 2B); • prior neoadjuvant or adjuvant treatment with a non-steroidal AI (ie, anastrozole or letrozole) with disease recurrence while on or within 12 months of completing treatment (Part 2C); • prior treatment with any CDK4/6 inhibitor for advanced disease (Part 2B and 2C); • radiation therapy within 4 weeks prior to study enrollment, with the exception of palliative radiotherapy following discussion with the sponsor."}
• {"criterion_text":"- Inadequate organ function."}
• {"criterion_text":"- Known bleeding disorders."}
• {"criterion_text":"- Participation in other studies involving investigational drug(s) within 4 weeks (or 5 half--lives, whichever is shorter) prior to study entry."}
• {"criterion_text":"- 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."}
• {"criterion_text":"- Current use or anticipated need for PPI within 7 days prior to first dose of the study intervention. For participants with gastroesophageal reflux disease, concurrent treatment with PPIs is not allowed and treatment with H2 blockers and/or antacids if medically required must be dosed according to protocol guidelines."}
• {"criterion_text":"- Previous high-dose chemotherapy requiring stem cell rescue."}
• {"criterion_text":"- Last anticancer treatment within 2 weeks (or 5 half-lives, whichever is shorter, unless the last immediate anticancer treatment contained an antibody-based agent(s) (approved or investigational), then the interval of 4 weeks or 5 half-lives (whichever is shorter) is required prior to receiving the study intervention (except in Part 2C where no systemic anticancer treatment in advanced or metastatic setting is allowed)."}

Primary endpoints

• {"endpoint_text":"- Part 1: First cycle DLTs.","definition_or_measurement_approach":"Dose-limiting toxicities (DLTs) assessed in Cycle 1 (no further definition provided in the available data)."}
• {"endpoint_text":"- Part 1: AEs as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0) timing, seriousness, and relationship to study intervention.","definition_or_measurement_approach":"Adverse events characterized by type, frequency, severity graded per NCI CTCAE v5.0, timing, seriousness, and relationship to study intervention."}
• {"endpoint_text":"- Part 1: Laboratory abnormalities as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), and timing.","definition_or_measurement_approach":"Laboratory abnormalities assessed by type, frequency, severity using NCI CTCAE v5.0 and timing."}
• {"endpoint_text":"- Part 1: Vital sign abnormalities.","definition_or_measurement_approach":"Vital sign measurements and abnormalities (specific measures not detailed in the available data)."}
• {"endpoint_text":"- Part 1: Heart rate corrected QT interval (eg, QTcF).","definition_or_measurement_approach":"QT interval corrected for heart rate (e.g., QTcF) measured by ECG."}
• {"endpoint_text":"- Part 2: First cycle DLTs (for the safety run-in).","definition_or_measurement_approach":"Dose-limiting toxicities in Cycle 1 during Part 2 safety run-in (no further definition provided)."}
• {"endpoint_text":"- Part 2: AEs as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), timing, seriousness, and relationship to study treatment.","definition_or_measurement_approach":"Adverse events characterized and graded per NCI CTCAE v5.0 with timing and relationship to treatment."}
• {"endpoint_text":"- Part 2: Laboratory abnormalities as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0, and timing.","definition_or_measurement_approach":"Laboratory abnormalities assessed by type, frequency, severity using NCI CTCAE v5.0 and timing."}

Secondary endpoints

• {"endpoint_text":"- Part 1: PK parameters of PF-07220060 and PF-07104091: • Single dose (PF-07104091) - Cmax, Tmax, AUClast, and as data permit, AUCinf, CL/F, Vz/F, and t1/2. • Multiple Dose (PF-07220060 & PF-07104091; assuming steady state is achieved) - Css,max, Tss,max, AUCss,τ, Css,min, CLss/F, and as data permit, Vss/F, t1/2, and Rac (AUCss,τ/AUCsd,τ) for PF-07104091.","definition_or_measurement_approach":"Pharmacokinetic parameters measured for single and multiple dosing as listed (Cmax, Tmax, AUC metrics, clearance, volumes, half-life, steady-state metrics)."}
• {"endpoint_text":"- Part 1: AEs as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0) timing, seriousness, and relationship to study intervention.","definition_or_measurement_approach":"Adverse events characterized and graded per NCI CTCAE v5.0."}
• {"endpoint_text":"- Part 1: Laboratory abnormalities as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), and timing.","definition_or_measurement_approach":"Laboratory abnormalities characterized and graded per NCI CTCAE v5.0."}
• {"endpoint_text":"- Part 1: • ORR, as assessed using RECIST version 1.1.","definition_or_measurement_approach":"Objective Response Rate assessed by RECIST v1.1."}
• {"endpoint_text":"- Part 1: TTE endpoints: eg, DoR, PFS, and TTP.","definition_or_measurement_approach":"Time-to-event endpoints including Duration of Response (DoR), Progression-Free Survival (PFS), and Time to Progression (TTP) per applicable definitions (RECIST 1.1 for tumor assessments)."}
• {"endpoint_text":"- Part 2: ORR and CBR as assessed using RECIST version 1.1.","definition_or_measurement_approach":"Objective Response Rate and Clinical Benefit Rate assessed per RECIST v1.1."}
• {"endpoint_text":"- Part 2: TTE endpoints: DoR, PFS, and TTP.","definition_or_measurement_approach":"Time-to-event endpoints including DoR, PFS, and TTP."}
• {"endpoint_text":"- Part 2: Concentrations of PF-07220060 and PF-07104091 at selected time points.","definition_or_measurement_approach":"Plasma concentrations of the investigational products measured at specified time points (specific time points not provided in the available data)."}

Spain

Earliest CTIS Part Ii Submission Date

21-05-2024

Latest Decision Or Authorization Date

21-04-2025

Processing Time Days

335

Number Of Sites

5

Number Of Participants

19

Czechia

Earliest CTIS Part Ii Submission Date

21-05-2024

Latest Decision Or Authorization Date

26-05-2025

Processing Time Days

370

Number Of Sites

3

Number Of Participants

16

Bulgaria

Earliest CTIS Part Ii Submission Date

21-05-2024

Latest Decision Or Authorization Date

24-07-2025

Processing Time Days

429

Number Of Sites

4

Number Of Participants

14

Primary sponsor

Full Name

Pfizer Inc.

Organisation Type

Pharmaceutical company

Country Of Registered Address

United States

Contract research organisations

Name

Syneos Health Inc.

Responsibilities

Site Management

Name

Ppd Inc.

Responsibilities

PK Analysis; During Study Storage; Temporary Post-Study Storage

Third parties

• {"country":"United States","full_name":"Syneos Health Inc.","duties_or_roles":"Site Management","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Labcorp Central Laboratory Services LP","duties_or_roles":"Central Lab; Lab kit distribution; During Study Storage; Slide Sectioning","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Q Squared Solutions Holdings LLC","duties_or_roles":"Sample Analysis: Blood for serum biomarker (Thymidine Kinase)","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"United States","full_name":"Pfizer Inc.","duties_or_roles":"During Study Storage; Long-term Storage; Tumor Biopsies; Skin Punch Biopsies; Genotyping and analysis","organisation_type":"Pharmaceutical company"}
• {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"Central Lab; Lab kit distribution; During Study Storage; Slide Sectioning","organisation_type":"Pharmaceutical company"}
• {"country":"Belgium","full_name":"CellCarta","duties_or_roles":"Sample Analysis: Cyclin D1, Cyclin E1, pRb/Ki67, FoxM1 IHC","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"United States","full_name":"Azenta US Inc.","duties_or_roles":"During Study Storage; Long-term Storage; Blood for ctDNA profiling; Blood for tumor NGS normal control; Blood for serum biomarkers; Retained Research Sample Prep D1","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Ppd Inc.","duties_or_roles":"PK Analysis; During Study Storage; Temporary Post-Study Storage","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Personalis Inc.","duties_or_roles":"Sample Analysis: Whole exome and whole transcriptome sequencing","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"United States","full_name":"Guardant Health Inc.","duties_or_roles":"Sample Analysis: ctDNA NGS (breast cohorts)","organisation_type":"Laboratory/Research/Testing facility"}