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: 20.0Level: PTClassification code 10006187Term: Breast cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 20.1Level: PTClassification code 10055113Term: Breast cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2022-002173-28-ES
• Lead Sponsor: Pfizer Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-01-31
• Last Update Posted: 18 July 2023

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• 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
- Current use or anticipated need for PPI within 14 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.
- Previous high-dose chemotherapy requiring stem cell rescue.
- 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).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified