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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-524387-38-00 | EU Trial (CTIS) Number |
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The purpose of this study is to learn about the safety and effects of the study medicine when given alone or together with other anti-cancer therapies. Anti-cancer therapy is a type of treatment to stop the growth of cancer. This study also aims to find the best amount of study medication.
This study is seeking participants that have advanced or metastatic breast cancer (BC), or advanced or metastatic colorectal cancer (CRC).
All participants in this study will take the study medication (PF-08032562) as pill by mouth. This will be repeated for 28-day cycles.
Depending on which part of the study participants are enrolled into, they will receive the study medication PF-08032562 alone or in combination with other anti-cancer medications. The study medication (PF-08032562) will be taken by mouth (PO) in combination with other anti-cancer medications given in the study clinic by intramuscular (IM) injection into the muscle or intravenous (IV) infusion that is directly injected into the veins at different times (depending on the treatment) during the 28-day cycle. The study may also test different schedules.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1 Dose Escalation Cohort 1A | Experimental | PF-08032562 monotherapy dose escalation for participants with advanced or metastatic BC or CRC, at different doses and/or schedules of the study drug |
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| Part 1 Dose Escalation Cohort 1B | Experimental | Combination (PF-08032562 + fulvestrant) dose escalation for participants with advanced or metastatic BC, at different doses and/or schedules of the study drug |
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| Part 1 Dose Escalation Cohort 1C | Experimental | Combination (PF-08032562 + cetuximab) dose escalation for participants with advanced or metastatic CRC, at different doses and/or schedules of the study drug |
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| Part 1 Dose Escalation Cohort 1D | Experimental | Combination (PF-08032562 + [FOLFOX + bevacizumab]) dose escalation for participants with advanced or metastatic CRC, at different doses and/or schedules of the study drug |
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| Part 2 Dose Expansion Cohort 2A | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-08032562 | Drug | Taken by mouth (PO) |
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| Measure | Description | Time Frame |
|---|---|---|
| Part 1 (Dose Escalation): Number of participants with Dose-Limiting Toxicities (DLT) | Any adverse events that are attributable to one, the other, or both study treatments, occurring in the DLT observation period are considered DLTs, excluding toxicities clearly due to underlying disease or extraneous causes. | Baseline up to 28 days |
| Part 1 (Dose Escalation): Number of participants with laboratory abnormalities | Number of participants with laboratory test abnormalities. | From start of treatment up to 30 days after last dose or start of new anticancer therapy, whichever occurred first |
| Part 1 (Dose Escalation): Incidence of Adverse Events (AEs) | An adverse event (AE) was any untoward medical occurrence in a participant who received study medication without regard to possibility of causal relationship to it. | From start of treatment up to 30 days after last dose or start of new anticancer therapy, whichever occurred first |
| Part 2 (Dose Expansion): Objective Response Rate (ORR) | ORR defined as per Response Evaluation Criteria in Solid Tumors (RECIST v1.1). | Baseline and every 8 to 12 weeks through time of confirmed disease progression, death, unacceptable toxicity, or through study completion (approximately 2 years) |
| Measure | Description | Time Frame |
|---|---|---|
| Part 1 & Part 2: Maximum Observed Serum Concentration (Cmax) | Evaluate the single and multiple dose PK of PF-08032562 as monotherapy, or in combination with other anti-tumor agents. | Baseline through end of Cycle 1 (each cycle is 28 days) |
| Part 1 & Part 2: Time to Reach Maximum Observed Serum Concentration (Tmax) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pfizer CT.gov Call Center | Contact | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope (City of Hope National Medical Center, City of Hope Medical Center) | Recruiting | Duarte | California | 91010 | United States |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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Combination (PF-08032562 + fulvestrant) dose expansion for participants with advanced or metastatic BC, at different doses and/or schedules of the study drug
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| Part 2 Dose Expansion Cohort 2B | Experimental | PF-08032562 monotherapy or combination (PF-08032562 + cetuximab) dose expansion for participants with advanced or metastatic CRC, at different doses and/or schedules of the study drug |
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| Part 2 Dose Expansion Cohort 2C | Experimental | Combination (PF-08032562 + [FOLFOX + bevacizumab]) dose expansion for participants with advanced or metastatic CRC, at different doses and/or schedules of the study drug |
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| Fulvestrant | Drug | Selective Estrogen Receptor Degrader (SERD) |
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| Cetuximab | Drug | Monoclonal antibody (EGFR inhibitor) |
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| Fluorouracil | Drug | Part of FOLFOX chemotherapy regimen cytotoxic chemotherapy (antimetabolite and pyrimidine analog) |
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| Oxaliplatin | Drug | Part of FOLFOX chemotherapy regimen platinum based compound (alkylating agent) |
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| Leucovorin | Drug | Part of FOLFOX chemotherapy regimen (folic acid analog) |
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| Bevacizumab | Drug | Monoclonal antibody (VEG-F inhibitor) |
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Evaluate the single and multiple dose PK of PF-08032562 as monotherapy, or in combination with other anti-tumor agents. |
| Baseline through end of Cycle 1 (each cycle is 28 days) |
| Part 1: Area Under the Curve (AUC) from Time Zero to Last Quantifiable Concentration (AUClast) | Evaluate the single and multiple dose PK of PF-08032562 as monotherapy, or in combination with other anti-tumor agents. | Baseline through end of Cycle 1 (each cycle is 28 days) |
| Part 1: Effect of Food on Cmax | Evaluate the effect of food on Cmax of PF-08032562 as monotherapy | Baseline through end of Cycle 1 (each cycle is 28 days) |
| Part 1: Effect of Food on Tmax | Evaluate the effect of food on Tmax of PF-08032562 as monotherapy | Baseline through end of Cycle 1 (each cycle is 28 days) |
| Part 1: Effect of Food on AUClast | Evaluate the effect of food on AUClast of PF-08032562 as monotherapy | Baseline through end of Cycle 1 (each cycle is 28 days) |
| Part 1: Percent change of immune cells within tumors based on immunohistochemistry assessment | Evaluate the single and multiple dose pharmacodynamics of PF-08032562 as monotherapy, or in combination with other anti-tumor agents. This measure will assess change in the concentration of immune cell-related cytokines and chemokines as potential pharmacodynamic effects of PF-08032562 using Immunohistochemistry (IHC) assays. | Baseline through end of Cycle 1 (each cycle is 28 days) |
| Part 2 (Dose Expansion): Number of participants with laboratory abnormalities | Number of participants with laboratory test abnormalities. | From start of treatment up to 30 days after last dose or start of new anticancer therapy, whichever occurred first |
| Part 2 (Dose Expansion): Incidence of Adverse Events (AEs) | An adverse event (AE) was any untoward medical occurrence in a participant who received study medication without regard to possibility of causal relationship to it. | From start of treatment up to 30 days after last dose or start of new anticancer therapy, whichever occurred first |
| Part 1 & Part 2: Objective Response Rate (ORR) as per Response Evaluation Criteria in Solid Tumors (RECIST v1.1) | ORR is defined as the percentage of participants in the analysis population having a best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST v1.1. | Baseline and every 8 to 12 weeks through time of confirmed disease progression, death, unacceptable toxicity, or through study completion (approximately 2 years) |
| Part 1 & Part 2: Disease Control Rate (DCR) as per RECIST v1.1 | DCR is defined as the proportion of participants with CR or PR with confirmation, or Stable Disease (SD) per RECIST version 1.1. | Baseline and every 8 to 12 weeks through time of confirmed disease progression, death, unacceptable toxicity, or through study completion (approximately 2 years) |
| Part 1 & Part 2: Clinical Benefit Rate (CBR) as per RECIST v1.1 | CBR is defined as the percentage of participants with a best overall response of CR or PR at any time before Progressive Disease (PD), or non-CR/non-PD or SD for at least 24 weeks from start date of treatment and prior to PD, relative to the appropriate analysis set. | Baseline and every 8 to 12 weeks through time of confirmed disease progression, death, unacceptable toxicity, or through study completion (approximately 2 years) |
| Part 1 & Part 2: Duration of Response (DOR) as per RECIST v1.1 | DOR is defined as the time from first documentation of CR or PR to date of first documentation of PD or death due to any cause. | Baseline and every 8 to 12 weeks through time of confirmed disease progression, death, unacceptable toxicity, or through study completion (approximately 2 years) |
| Part 1 & Part 2: Progression-Free Survival (PFS) as per RECIST v1.1 | PFS is defined as time from start date of treatment to the date of first documentation of PD or death due to any cause. | Baseline and every 8 to 12 weeks through time of confirmed disease progression, death, unacceptable toxicity, or through study completion (approximately 2 years) |
| Part 1 & Part 2: Time to Response (TTR) as per RECIST v1.1 | TTR is defined as the time from start date of treatment to first documentation of CR or PR. | Baseline and every 8 to 12 weeks through time of confirmed disease progression, death, unacceptable toxicity, or through study completion (approximately 2 years) |
| Part 2: Overall Survival (OS) | OS is defined as time from from start date of treatment to the date of death due to any cause | Up to approximately 2 years |
| START Midwest, LLC | Recruiting | Grand Rapids | Michigan | 49546 | United States |
| The University of Texas MD Anderson Cancer Center - Conroe | Recruiting | Conroe | Texas | 77384 | United States |
| The University of Texas - M.D. Anderson Cancer Center | Recruiting | Houston | Texas | 77030 | United States |
| The University of Texas, MD Anderson Cancer Center - West Houston | Recruiting | Houston | Texas | 77079 | United States |
| The University of Texas, MD Anderson Cancer Center - League City | Recruiting | League City | Texas | 77573 | United States |
| START San Antonio | Recruiting | San Antonio | Texas | 78229 | United States |
| The University of Texas, MD Anderson Cancer Center - Sugar Land | Recruiting | Sugar Land | Texas | 77478 | United States |
| START Mountain Region | Recruiting | West Valley City | Utah | 84119 | United States |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D015179 | Colorectal Neoplasms |
| D064726 | Triple Negative Breast Neoplasms |
| D003110 | Colonic Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
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| ID | Term |
|---|---|
| D000077267 | Fulvestrant |
| D000068818 | Cetuximab |
| D005472 | Fluorouracil |
| D000077150 | Oxaliplatin |
| D002955 | Leucovorin |
| D000068258 | Bevacizumab |
| ID | Term |
|---|---|
| D004958 | Estradiol |
| D004963 | Estrenes |
| D004962 | Estranes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D045166 | Estradiol Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D005575 | Formyltetrahydrofolates |
| D013763 | Tetrahydrofolates |
| D005492 | Folic Acid |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D003067 | Coenzymes |
| D045762 | Enzymes and Coenzymes |
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