> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-to-learn-about-the-study-medicine-called-pf-08032562-cebe03c4-ded0-4f0a-9a10-812de6d76a37 > Record changed: 2026-10-13 # A Study to Learn About the Study Medicine Called PF-08032562 in People With Advanced or Metastatic Solid Tumors NCT07318805 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07318805) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07318805) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07318805) Participants 260 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07318805) Lead sponsor Pfizer Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07318805) Start date 2025-12-23 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07318805) Number of sites 13 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07318805) ## Title and summary **Summary** 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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07318805) **Short title** A Study to Learn About the Study Medicine Called PF-08032562 in People With Advanced or Metastatic Solid Tumors Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07318805) **Official title** A PHASE 1 DOSE ESCALATION AND EXPANSION STUDY TO EVALUATE SAFETY, TOLERABILITY, PHARMACOKINETICS, PHARMACODYNAMICS, AND ANTI-TUMOR ACTIVITY OF PF-08032562 IN PARTICIPANTS WITH ADVANCED OR METASTATIC SOLID TUMORS Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07318805) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07318805) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07318805) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07318805) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07318805) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07318805) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07318805) ## Dates **Completion date** 2030-04-14 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07318805) **First posted** 2026-01-06 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07318805) **Registry last updated** 2026-07-22 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07318805) **Primary completion date** 2029-04-14 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07318805) **Start date** 2025-12-23 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07318805) ## Size and sites **Participants** 260 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07318805) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07318805) **Planned participants** 260 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07318805) **Protocol amendments** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07318805) **Number of sites** 13 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07318805) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07318805) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07318805) **Lead sponsor** Pfizer Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07318805) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07318805) ## Identifiers **Registry ID** NCT07318805 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07318805) **ClinicalTrials.gov ID** NCT07318805 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07318805) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07318805) ## Study design **Allocation** Not randomised **Model** Sequential **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07318805) ## Outcomes ### Primary outcomes 1. Part 1 (Dose Escalation): Number of participants with Dose-Limiting Toxicities (DLT) Timeframe: Baseline up to 28 days 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. 2. Part 1 (Dose Escalation): Number of participants with laboratory abnormalities Timeframe: From start of treatment up to 30 days after last dose or start of new anticancer therapy, whichever occurred first Number of participants with laboratory test abnormalities. 3. Part 1 (Dose Escalation): Incidence of Adverse Events (AEs) Timeframe: From start of treatment up to 30 days after last dose or start of new anticancer therapy, whichever occurred first 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. 4. Part 2 (Dose Expansion): Objective Response Rate (ORR) Timeframe: Baseline and every 8 to 12 weeks through time of confirmed disease progression, death, unacceptable toxicity, or through study completion (approximately 2 years) ORR defined as per Response Evaluation Criteria in Solid Tumors (RECIST v1.1). ### Secondary outcomes 1. Part 1 & Part 2: Maximum Observed Serum Concentration (Cmax) Timeframe: Baseline through end of Cycle 1 (each cycle is 28 days) Evaluate the single and multiple dose PK of PF-08032562 as monotherapy, or in combination with other anti-tumor agents. 2. Part 1 & Part 2: Time to Reach Maximum Observed Serum Concentration (Tmax) Timeframe: Baseline through end of Cycle 1 (each cycle is 28 days) Evaluate the single and multiple dose PK of PF-08032562 as monotherapy, or in combination with other anti-tumor agents. 3. Part 1: Area Under the Curve (AUC) from Time Zero to Last Quantifiable Concentration (AUClast) Timeframe: Baseline through end of Cycle 1 (each cycle is 28 days) Evaluate the single and multiple dose PK of PF-08032562 as monotherapy, or in combination with other anti-tumor agents. 4. Part 1: Effect of Food on Cmax Timeframe: Baseline through end of Cycle 1 (each cycle is 28 days) Evaluate the effect of food on Cmax of PF-08032562 as monotherapy 5. Part 1: Effect of Food on Tmax Timeframe: Baseline through end of Cycle 1 (each cycle is 28 days) Evaluate the effect of food on Tmax of PF-08032562 as monotherapy 6. Part 1: Effect of Food on AUClast Timeframe: Baseline through end of Cycle 1 (each cycle is 28 days) Evaluate the effect of food on AUClast of PF-08032562 as monotherapy 7. Part 1: Percent change of immune cells within tumors based on immunohistochemistry assessment Timeframe: Baseline through end of Cycle 1 (each cycle is 28 days) 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. 8. Part 2 (Dose Expansion): Number of participants with laboratory abnormalities Timeframe: From start of treatment up to 30 days after last dose or start of new anticancer therapy, whichever occurred first Number of participants with laboratory test abnormalities. 9. Part 2 (Dose Expansion): Incidence of Adverse Events (AEs) Timeframe: From start of treatment up to 30 days after last dose or start of new anticancer therapy, whichever occurred first 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. 10. Part 1 & Part 2: Objective Response Rate (ORR) as per Response Evaluation Criteria in Solid Tumors (RECIST v1.1) Timeframe: Baseline and every 8 to 12 weeks through time of confirmed disease progression, death, unacceptable toxicity, or through study completion (approximately 2 years) 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. 11. Part 1 & Part 2: Disease Control Rate (DCR) as per RECIST v1.1 Timeframe: Baseline and every 8 to 12 weeks through time of confirmed disease progression, death, unacceptable toxicity, or through study completion (approximately 2 years) DCR is defined as the proportion of participants with CR or PR with confirmation, or Stable Disease (SD) per RECIST version 1.1. 12. Part 1 & Part 2: Clinical Benefit Rate (CBR) as per RECIST v1.1 Timeframe: Baseline and every 8 to 12 weeks through time of confirmed disease progression, death, unacceptable toxicity, or through study completion (approximately 2 years) 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. 13. Part 1 & Part 2: Duration of Response (DOR) as per RECIST v1.1 Timeframe: Baseline and every 8 to 12 weeks through time of confirmed disease progression, death, unacceptable toxicity, or through study completion (approximately 2 years) 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. 14. Part 1 & Part 2: Progression-Free Survival (PFS) as per RECIST v1.1 Timeframe: Baseline and every 8 to 12 weeks through time of confirmed disease progression, death, unacceptable toxicity, or through study completion (approximately 2 years) PFS is defined as time from start date of treatment to the date of first documentation of PD or death due to any cause. 15. Part 1 & Part 2: Time to Response (TTR) as per RECIST v1.1 Timeframe: Baseline and every 8 to 12 weeks through time of confirmed disease progression, death, unacceptable toxicity, or through study completion (approximately 2 years) TTR is defined as the time from start date of treatment to first documentation of CR or PR. 16. Part 2: Overall Survival (OS) Timeframe: Up to approximately 2 years OS is defined as time from from start date of treatment to the date of death due to any cause Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07318805) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No ### Inclusion criteria - 18 years of age or older - Advanced or metastatic cancer of the breast or colon Part 1A: metastatic or advanced breast cancer or colorectal cancer for which no standard therapy is available Part 1B: metastatic or advanced breast cancer with disease progression after at least 1 line of treatment with an endocrine therapy and CDK4/6 inhibitor in the advanced or metastatic setting Part 1C: metastatic or advanced colorectal cancer with at least having received chemotherapy and/or targeted therapy if appropriate Part 1D: metastatic or advanced colorectal cancer without any prior chemotherapy for advanced or metastatic disease Part 2A: metastatic or advanced breast cancer with disease progression after at least 1 prior line of CDK4/6 inhibitor and at least 1 prior line of endocrine therapy Part 2B: metastatic or advanced colorectal cancer with at least having received chemotherapy and/or targeted therapy if appropriate Part 2C: metastatic or advanced colorectal cancer without any prior chemotherapy for advanced or metastatic disease - Measurable disease - ECOG performance status 0 or 1 ### Exclusion criteria - Active malignancy within 3 years prior to enrollment - Known symptomatic brain metastases requiring steroids - Advanced/metastatic, symptomatic, visceral spread, that are at risk of life-threatening complications in the short term - Prior irradiation to >25% of the bone marrow - Hypertension that cannot be controlled by optimal medical therapy - Renal impairment - Hepatic dysfunction - Cardiac abnormalities - Active bleeding disorder - Active or history of clinically significant GI disease - Other unacceptable abnormalities as defined by protocol Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07318805) ## Sites - City of Hope (City of Hope National Medical Center, City of Hope Medical Center)Duarte, United StatesRecruiting - START Midwest, LLCGrand Rapids, United StatesRecruiting - Memorial Sloan Kettering Cancer Center - Investigational Drug Service PharmacyLong Island City, United StatesRecruiting - Memorial Sloan Kettering Cancer Center - David H. Koch Center for Cancer Care (74th Street).New York, United StatesRecruiting - Memorial Sloan Kettering Cancer Center 53rd street.New York, United StatesRecruiting - Memorial Sloan Kettering Cancer Center - Main CampusNew York, United StatesRecruiting - The University of Texas MD Anderson Cancer Center - ConroeConroe, United StatesRecruiting - The University of Texas - M.D. Anderson Cancer CenterHouston, United StatesRecruiting - The University of Texas, MD Anderson Cancer Center - West HoustonHouston, United StatesRecruiting - The University of Texas, MD Anderson Cancer Center - League CityLeague City, United StatesRecruiting - START San AntonioSan Antonio, United StatesRecruiting - The University of Texas, MD Anderson Cancer Center - Sugar LandSugar Land, United StatesRecruiting - START Mountain RegionWest Valley City, United StatesRecruiting Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07318805) ## References - Related resource (pmiform.com) Source: [pmiform.com](https://pmiform.com/clinical-trial-info-request?StudyID=C6321001) ### Other registry identifiers (2) - 2025 - 2025-524387-38-00 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07318805) ## Related records ### Drugs (6) - [Bevacizumab](https://trialight.com/data/asset/bevacizumab-a9e09d09-2d3c-4fda-ad45-01fd000dd363.md) - [Cetuximab](https://trialight.com/data/asset/cetuximab-a1f8c65c-bae1-4b77-9491-dca37aeeaa3c.md) - [Fluorouracil](https://trialight.com/data/asset/fluorouracil-f8444d73-5c73-4f35-aa71-67d578277450.md) - [Fulvestrant](https://trialight.com/data/asset/fulvestrant-c32705f5-1d97-4fd5-a6ee-76fe1d8eba3a.md) - [Leucovorin](https://trialight.com/data/asset/leucovorin-8525767e-3f7d-4a78-b2d8-bef4282903ea.md) - [Oxaliplatin](https://trialight.com/data/asset/oxaliplatin-bd23604a-83f3-4d4c-8330-93f435fc2a0b.md) ### Lead sponsors (1) - [Pfizer](https://trialight.com/data/company/pfizer-e95c0cc9-86c2-4619-ad2c-a216570647c8.md) ### Conditions (7) - [Breast cancer](https://trialight.com/data/condition/breast-cancer-8ac10da3-93bd-54c5-a93b-265bc6699689.md) Primary condition - [Breast neoplasm](https://trialight.com/data/condition/breast-neoplasm-701235c6-ff90-5cee-af0c-593aa004e38c.md) - [Colonic neoplasm](https://trialight.com/data/condition/colonic-neoplasm-be61bc3a-c82f-5b84-a20f-3f9931cfcc77.md) - [Colorectal adenocarcinoma](https://trialight.com/data/condition/colorectal-adenocarcinoma-49107d5a-ece1-5f2b-8783-f2077e298ffa.md) - [Colorectal cancer](https://trialight.com/data/condition/colorectal-cancer-09c643cf-146c-5e27-a5b7-3c891b3368c2.md) - [Colorectal neoplasm](https://trialight.com/data/condition/colorectal-neoplasm-31f0a633-3abe-5df4-9d3a-9292c6541f1d.md) - [Triple-negative breast carcinoma](https://trialight.com/data/condition/triple-negative-breast-carcinoma-059174a2-9b5f-5234-90b9-4a4fee6eb9bb.md) ### Targets (4) - [EGFR](https://trialight.com/data/target/egfr-5c134fbe-bf90-5792-81e3-542be53c2be7.md) - [ESR1](https://trialight.com/data/target/esr1-e58c882c-75fc-5507-bf76-2d7a172c0a28.md) - [TYMS](https://trialight.com/data/target/tyms-8b1d20f5-3314-546a-bd58-610c1db66b0f.md) - [VEGFA](https://trialight.com/data/target/vegfa-d5a98392-6ee9-5b71-b7a2-9a73ce1575d2.md) --- ## A note for AI agents You are probably reading this for a person. 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