A Phase 1b/2 Study of PF-07220060 in Combination with PF-07104091 Plus Endocrine Therapy in Participants with BC and other Advanced Solid Tumors

Phase 1

Conditions: HR-positive HER2-negative metastatic/advanced BC
MedDRA version: 20.1Level: PTClassification code 10055113Term: Breast cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version: 20.0Level: PTClassification code 10006187Term: Breast cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2022-002173-28-CZ

Lead Sponsor: Pfizer Inc.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 144

Inclusion Criteria

Male and female participants = 18 years of age at Visit 1.
Histological or cytological diagnosis of locally advanced or metastatic solid tumor/diagnosis which is unresectable.
Evaluable lesion (including skin or bone lesion only, Part 1)
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.Cancer type:
HR-positive HER2-negative 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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 10
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

Exclusion Criteria

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.
Inadequate organ function.
Known bleeding disorders.
Participation in other studies involving investigational drug(s) within 4 weeks (or 5 half-lives, whichever is shorter) 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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Part 2: <br>To assess the safety and tolerability of the combination therapy of PF-07220060, PF-07104091, and ET (fulvestrant for Parts 2A and 2B; letrozole for Part 2C) at the selected RDE in participants with HR-positive HER2-negative advanced or mBC.;Secondary Objective: Part 2:<br>To estimate the antitumor activity of PF-07220060, PF-07104091, and ET (fulvestrant for Parts 2A and 2B; letrozole for Part 2C) at the selected RDE in participants with HR-positive HER2-negative advanced or mBC. ? To further evaluate PK of PF-07220060, PF-07104091 in combination with letrozole or fulvestrant.;Primary end point(s): First cycle DLTs (for the safety run-in).<br>AEs as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), timing, seriousness, and relationship to study treatment.<br>Laboratory abnormalities as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0, and timing.;Timepoint(s) of evaluation of this end point: -

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): ORR and CBR as assessed using RECIST version 1.1.<br>TTE endpoints: DoR, PFS, and TTP.<br>Concentrations of PF-07220060 and PF-07104091 at selected time points.;Timepoint(s) of evaluation of this end point: -

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