Recruiting nowPhase 2
What this trial is trying to do
The researchers are testing different doses of PF-07220060, alone and alongside hormone treatments such as fulvestrant, letrozole, tamoxifen or enzalutamide. The trial asks which doses can be given safely and how the drug behaves in the body, including whether combinations change its effects or breakdown.
The aim is to choose doses that can be studied in later trials while limiting dose-limiting toxicities, rather than to show that the treatment helps people live longer or keeps cancer from growing. Some expansion groups will compare PF-07220060 alone with PF-07220060 plus fulvestrant, but the overall study has no randomised comparison with standard treatment.
Worth knowing: This is an early-phase, open-label, nonrandomised study whose main outcome is safety, so it is not designed to establish treatment benefit; it is also a broad solid-tumour trial rather than a colorectal-cancer-specific study.
Written from the trial's own registry entry to explain what the researchers are testing and why. Nothing here is a result — this trial has not reported one — and it is not a view on whether the treatment works or on whether it would suit you.
| Registry number | NCT04557449 |
|---|---|
| Recruitment | Recruiting now |
| Phase | Phase 2 |
| Design | not randomised, open label |
| Taking part | 430 people (planned) |
| Who can join | aged 18 Years and over |
| Run by | Pfizer |
| Started | |
| Main results expected | |
| Record last updated |
What is being tested
- Drug PF-07220060
- Combination product Letrozole
- Combination product Fulvestrant
- Other Midazolam
- Combination product Enzalutamide
- Combination product Giredestrant
- Combination product Tamoxifen
What it is measuring
Number of participants with dose limiting toxicities in the Dose Escalation or De-escalation Portion
This is the trial's main question — the one it is designed and sized to answer. Anything else it reports is a secondary finding, and secondary findings are far more likely to be chance.
Phase 2. Tests whether the treatment works well enough to be worth a larger trial. Usually too small to prove it changes survival.
How the researchers describe it
This is a Phase 1/2A, open label, multicenter, nonrandomized, multiple dose, safety, tolerability, pharmacokinetic and pharmacodynamic study of PF-07220060 administered as a single agent and in combination with endocrine therapy.
Part 1 includes dose escalation cohorts evaluating PF-07220060 as single agent or in combination with endocrine therapy or enzalutamide, as well as a food effect cohort and a DDI cohort.
Part 2 includes dose expansion cohorts evaluating PF-07220060 in combination with endocrine therapy or enzalutamide.
The Giredestrant Combination Cohort will evaluate PF-07220060 in combination with giredestrant.
In Part 1A, single escalating doses of PF-07220060 alone will be administered to determine the maximum tolerated dose (MTD) and select the recommended dose for expansion.
In Part 1B and Part 1C, PF-07220060 will be administered in combination with 1 of 2 endocrine therapies (letrozole and fulvestrant, respectively).
In Part 1D, food effect assessment of PF-07220060 at the RP2D dose level from Part 1A will be conducted.
In Part 1E, the effect of PF-07220060 on the PK of midazolam will be evaluated (DDI).
In Part 1F, escalating doses of PF-07220060 will be administered in combination with enzalutamide.
In Part 1G, PF-07220060 will be administered in combination with tamoxifen to determine the RDE.
Part 2A is an expansion cohort for PF-07220060 in combi…
Written by the trial’s sponsor, quoted from its ClinicalTrials.gov record.
What this trial is looking for
- HER2 positive
- Metastatic
Read automatically from the criteria below, to make the list searchable. It is a summary of what the text mentions, not a decision about whether you qualify — and where the two disagree, the criteria are right and this is wrong.
Who the trial is looking for
Inclusion Criteria
- Part 1: Breast Cancer (BC)
- Refractory Hormone Receptor Positive (HR+), Human Epidermal Growth Factor Receptor 2 Negative (HER2-) BC
- Part 1A/Part 1D/Part 1E also include: Refractory HR-positive/HER2-positive BC
- Part 1: Tumors other than BC (Part 1A/Part 1D/Part 1E): NSCLC, prostate, CRC, liposarcoma, or tumors with previously confirmed CDK4 or CCND1 amplification according to local standard tests
- Part 1F: prostate cancer
- Part 1G: HR-positive/HER2-negative BC
- Part 2A, 2B, 2C, 2E, and 2F: HR-positive/HER2-negative BC
- Part 1D: metastatic castration resistant prostate cancer
- Giredestrant Combination Cohort: ER-positive/HER2-negative BC
- Prior systemic Treatment
- Part 1: HR-positive/HER2-negative BC
- At least 1 line of SOC, including CD4/6 inhibitor therapy for advanced or metastatic disease, or if CDK4/6 inhibitors are not considered appropriate in the opinion of the investigator
- HR-positive/HER2-positive BC (Parts 1A/1D/1E): at least 1 prior treatment of approved HER2 targeting therapy
- Tumors other than BC (Parts 1A/1D/1E/1F): tumor that is resistant to at least 2 lines of SOC for advanced or recurrent disease or for which no standard therapy is available
- Part 2A and 2E: at least 1 line of standard of care (including prior CDK4/6i) for advanced/metastatic disease; Prior chemo is allowed; Prior fulvestrant, mTOR and/or PI3K in…
This is an extract. Whether you qualify is decided by the trial team against the full criteria, not by reading this page. Read the full eligibility criteria
Where it is running
Running at 39 sites. Listed in: Argentina, China, Czechia, Japan, Mexico, Slovakia, United Kingdom, United States.
Individual hospitals, and whether each is currently open, are listed on the registry record. Sites open and close throughout a trial.
Worth asking your oncology team
Being listed here is not a recommendation, and no one page can tell you whether a trial is right for you. These are the questions it raises.
- Is this trial open at a hospital I could realistically travel to?
- Given my stage, my previous treatment and my tumour's molecular profile, would I be eligible?
- What would I be giving up by joining — is the comparison arm the treatment I would otherwise be having?
- What is already known about the safety of what is being tested?
The source
Registry record NCT04557449, registered by Pfizer on ClinicalTrials.gov, a public database run by the US National Library of Medicine. The details on this page come from that record and are only ever as current as the sponsor has kept it.
This is a listing of a registered clinical trial, reproduced for information. It is not a recommendation, this site has no connection to the trial or its sponsor, and being listed here says nothing about whether the treatment works. Talk to your own oncology team before pursuing any trial.
This article summarises published research for general information. It is not medical advice, and it is not a substitute for a conversation with your own oncology team, who know your case. Do not start, stop, or change any treatment or supplement on the basis of what you read here.