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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
EU CTIS ID: 2023-509504-15-00
What this study is testing
Part 1: To assess the safety and tolerability of increasing doses of PF-07220060 and PF-07104091 as a combination treatment in participants with advanced solid tumors, in order to estimate MTD and select the RDE(s). Part 2: To assess the safety and tolerability of the combination therapy of PF07220060, PF07104091, and ET (fulvestrant for Parts 2A and 2B; letrozole for Part 2C) at the selected RDE(s) in participants with HRpositive HER2negative advanced or mBC.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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 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.
You likely can't join if
- 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 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.
See the full eligibility 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 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.
- 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 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.
- 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).
The study team makes the final eligibility decision.
Where it's taking place
- China
- Argentina
- Mexico
- Brazil
- United States
- South Africa
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include China; Argentina; Mexico; Brazil; United States; South Africa. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.