Study to Test the Safety and Tolerability of PF-07220060 in Participants With Advance Solid Tumors
A PHASE 1/2A STUDY EVALUATING THE SAFETY, TOLERABILITY, PHARMACOKINETICS, PHARMACODYNAMICS, AND ANTI-TUMOR ACTIVITY OF PF-07220060 AS A SINGLE AGENT AND AS PART OF COMBINATION THERAPY IN PARTICIPANTS WITH ADVANCED SOLID TUMORS
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests the safety of PF-07220060 and finds doses people can tolerate. It is for people with certain advanced solid tumors, including breast and prostate cancer. The drug is tested alone and with other treatments, including hormone therapy.
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 combination with fulvestrant and will explore more than one dose of PF-07220060. Part 2B and Part 2C are expansion cohorts for PF-07220060 in combination with letrozole and fulvestrant, respectively. Part 2E is an expansion cohort to evaluate PF-07220060 Monotherapy versus PF-07220060 plus fulvestrant combination therapy. Part 2F is an expansion cohort for PF-07220060 in combination with tamoxifen. The Giredestrant Combination Cohort Group A will determine the tolerable dose of PF-07220060 in combination with giredestrant. In Group B, additional participants will be enrolled at the tolerable dose to further assess safety and PK. The China and Japan monotherapy cohorts will evaluate safety, tolerability, and PK of PF-07220060 as single agent in Chinese and Japanese participants, respectively.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Have a cancer type that matches a study group. Most breast cancer groups require HR-positive, HER2-negative cancer: cancer that uses hormones to grow and does not have high levels of the HER2 protein.
- Some groups allow HER2-positive breast cancer, certain lung cancers, prostate cancer, colon or rectal cancer, liposarcoma (a cancer of fat cells), or tumors with extra copies of the CDK4 or CCND1 genes.
- The giredestrant group requires ER-positive, HER2-negative breast cancer. ER-positive means the cancer uses the hormone estrogen to grow.
- Most groups require past cancer treatment. The required drugs and number of treatments vary by group. Parts 1G and 2F require at least 2 prior treatments; the giredestrant group requires 1 to 3.
- Part 2B requires no past whole-body cancer treatment for advanced breast cancer. Part 2C requires cancer that got worse during or soon after certain hormone treatments.
- Treatments known to help your cancer must have stopped working or caused side effects you could not tolerate.
- Be fully active, or able to walk and do light work despite limits on hard physical activity.
- Have kidneys, liver, and bone marrow that work well enough.
Who can't join
- Part 2B: past CDK4/6 inhibitor treatment, or cancer that returned during or within 12 months after certain hormone treatment given before or after surgery. Part 2C: past treatment with a CDK inhibitor, fulvestrant, everolimus, or a drug that blocks the PI3K-mTOR pathway.
- Cancer spread to the brain or spinal cord that is active and uncontrolled or causes symptoms, or cancer in their surrounding tissues or fluid.
- Another active cancer within 3 years, except certain skin cancers or cancer that has stayed where it started and was adequately treated.
- Major surgery or radiation within 4 weeks, cancer treatment within 2 weeks, or an experimental drug study within 4 weeks of the study's stated start point. Parts 1G and 2F also exclude tamoxifen use within 35 days before study Day -4.
- Parts 1G and 2F: current or past blood clots in the lungs or deep veins.
- Giredestrant group: an unexplained slow heartbeat with symptoms now or within the past 6 months, or a resting heart rate below 50 beats per minute at screening.
- Pregnant or breastfeeding.
- Active swelling or irritation in the stomach or intestines, known pouches in the bowel wall, past surgery to remove part of the stomach or place a lap band, or other problems with digestion.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
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 inhibitors are allowed * Part 2B: no prior systemic anti-cancer therapies for advanced/metastatic BC * Part 2C: * Progressed during treatment or within 12 months of completion of adjuvant therapy with an aromatase inhibitor if postmenopausal, or tamoxifen if pre or perimenopausal, or * Progressed while on or within 1 month after the endo the prior aromatase inhibitor therapy for advanced/metastatic BC if postmenopausal or prior endocrine treatment for advanced/metastatic BC if pre or perimenopausal * One previous line of chemotherapy for advanced/metastatic disease is allowed in addition to endocrine therapy * Part 1G and 2F: at least 2 lines of SOC for advanced or metastatic disease, including CDK4/6 inhibitor and endocrine therapy * Giredestrant Combination Cohort: at least 1 (no more than 3) prior line(s) of SOC for advanced or metastatic disease, including CDK4/6 inhibitor and endocrine therapy General Inclusion Criteria * All participants must be refractory to or intolerant of existing therapies known to provide clinical benefit for their condition. * Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1 * Adequate renal, liver, and bone marrow function Exclusion Criteria: * Part 2B: prior neoadjuvant or adjuvant treatment with a non-steroidal aromatase inhibitor with disease recurrence while on or within 12 months of completing treatment. Prior treatment with any CDK4/6 inhibitor * Part 2C: prior treatment with any CDK inhibitor, fulvestrant, everolimus, or any agent whose mechanism of action is to inhibit the PI3K-mTOR pathway * Known active uncontrolled or symptomatic Central Nervous System (CNS) metastases carcinomatous meningitis, or leptomeningeal disease * Other active malignancy within 3 years prior to randomization, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ * Major surgery or radiation within 4 weeks prior to study intervention * Last anti-cancer treatment within 2 weeks prior to study intervention; Part 1G and 2F: tamoxifen treatment within 35 days of Day -4 * Participation in other studies involving investigational drug(s) within 4 weeks prior to study entry * Part 1G and 2F: history of or current pulmonary embolism or deep vein thrombosis * Giredestrant Combination Cohort: history (within 6 months of screening) of or presence of idiopathic symptomatic bradycardia or resting heart rate \<50 bpm at screening * Pregnant or breastfeeding female participant * Active inflammatory gastrointestinal (GI) disease, known diverticular disease or previous gastric resection or lap band surgery including impairment of gastrointestinal function or GI disease
Study sites (14)
CA
- Ellison Institute · Los Angeles, CA 90064More trials in Los Angeles
CT
- Smilow Cancer Hospital - Yale New Haven Health · New Haven, CT 06510More trials in New Haven
- Yale-New Haven Hospital-Yale Cancer Center · New Haven, CT 06510More trials in New Haven
- Smilow Cancer Hospital Phase 1 Unit · New Haven, CT 06511More trials in New Haven
- Yale University - Smilow Cancer Hospital; C/O Thomas Ferencz, RPh, BCOP · New Haven, CT 06511More trials in New Haven
- Smilow Cancer Hospital - Trumbull · Trumbull, CT 06611More trials in Trumbull
MA
- Brigham & Women's Hospital · Boston, MA 02115More trials in Boston
- Dana-Farber Cancer Institute · Boston, MA 02215More trials in Boston
- Dana Farber Cancer Institute- Chestnut Hill · Newton, MA 02467More trials in Newton
MI
- START Midwest · Grand Rapids, MI 49546More trials in Grand Rapids
TN
- Sarah Cannon Research Institute - Pharmacy · Nashville, TN 37203More trials in Nashville
- SCRI Oncology Partners · Nashville, TN 37203More trials in Nashville
TX
- The University of Texas MD Anderson Cancer Center · Houston, TX 77030More trials in Houston
- The University of Texas, MD Anderson Cancer Center - West Houston · Houston, TX 77079More trials in Houston