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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-523526-40-00 | EU Trial (CTIS) Number | ||
| Symbiotic-Lung-20 | Other Identifier | Pfizer |
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This study is being done to learn more about a new medicine called PF-08634404 and how it works when used with other cancer medicines in people who have advanced solid tumors. An advanced solid tumor is a type of cancer that has spread beyond its original location and cannot be removed by surgery or cured with standard treatments.
To join in the study, participants must:
The study will look at:
The study has different parts, each testing PF-08634404 with a different cancer medicine:
Participants will receive the study medicines through an intravenous (IV) infusion (injected into the vein) at the study clinic. All treatments will take place at clinical trial sites, where trained medical staff will monitor participants during and after each visit.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PF-08634404 + Sigvotatug Vedotin (Part A) | Experimental | Participants will receive PF-08634404 in combination with Sigvotatug Vedotin. |
|
| PF-08634404 + Combination Agent 1 (Part B) | Experimental | Participants will receive PF-08634404 in combination with other anticancer agents as per protocol. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-08634404 | Biological | -Concentrate for solution for infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), timing, seriousness, and relationship to study intervention. | Through 90 days after the last study intervention; Up to approximately 5 years |
| Phase I: Number of participants with dose limiting toxicity (DLT) | Dose limiting toxicity based on dose limiting toxicity evaluable participants. The number of participants who experienced DLTs during the DLT observation period. | Through 90 days after the last study intervention; Up to approximately 5 years |
| Phase 2: Confirmed Objective Response Rate (ORR) per RECIST v1.1 by investigator | ORR is defined as the proportion of participants with a Best Overall Response (BOR) of confirmed Complete Response (CR) or confirmed Partial Response (PR) per RECIST v1.1. | Up to approximately 5 Years |
| Measure | Description | Time Frame |
|---|---|---|
| Phase I: Confirmed ORR per RECIST v1.1 by investigator | ORR is defined as the proportion of participants with a Best Overall Response (BOR) of confirmed Complete Response (CR) or confirmed Partial Response (PR) per RECIST v1.1. | Up to approximately 5 Years |
| Disease Control Rate (DCR) per RECIST v1.1 by investigator |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | Overall survival defined as the time from the date of randomization to the date of death due to any cause. | Up to approximately 5 years |
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 |
|---|---|---|---|---|---|---|
| Highlands Oncology Group, PA | Recruiting | Fayetteville | Arkansas | 72703 | 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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|
| Sigvotatug Vedotin | Biological | -Powder for concentrate for solution for infusion. Single use vial |
|
|
| Combination Agent 1 | Biological | -Powder for concentrate for solution for infusion. Single use vial. |
|
DCR by investigator assessment is defined as the proportion of participants with CR or PR with confirmation, or Stable Disease (SD) by investigator assessment per RECIST version 1.1. |
| Up to approximately 5 years |
| Duration of Response (DOR) per RECIST v1.1 by investigator | DOR is defined as the time from the first documentation of objective response (CR or PR that is subsequently confirmed) to the date of first documented disease progression per RECIST v1.1 or death due to any cause, whichever occurs first. | Up to approximately 5 years |
| Progression Free Survival (PFS) per RECIST v1.1 by investigator | Progression-free survival is defined as the time from the date of randomization to the date of the first documentation of objective PD assessed by investigator per RECIST v1.1, or death due to any cause, whichever occurs first. | Up to approximately 5 years |
| Number of Participants With Clinical Laboratory Abnormalities | Through 90 days after the last study intervention; Up to approximately 5 years |
| Pharmacokinetics (PK): Serum concentration of PF-08634404 with anticancer agents | To characterize the pharmacokinetics (PK) of PF-08634404 with anticancer agents. | Up to 37 days after the last dose of treatment |
| Incidence of Anti-Drug Antibody (ADA) against PF-08634404 with anticancer agents | To characterize the immunogenicity of PF-08634404 with anticancer agents. | Up to 37 days after the last dose of treatment |
| Highlands Oncology Group, PA |
| Recruiting |
| Rogers |
| Arkansas |
| 72758 |
| United States |
| Highlands Oncology Group, PA | Recruiting | Springdale | Arkansas | 72762 | United States |
| Providence Medical Foundation | Recruiting | Fullerton | California | 92835 | United States |
| Providence St. Jude Medical Center - Virginia K. Crosson Cancer Center and Infusion Center | Recruiting | Fullerton | California | 92835 | United States |
| Providence St. Jude Medical Center | Recruiting | Fullerton | California | 92835 | United States |
| Rocky Mountain Cancer Centers, LLP | Recruiting | Denver | Colorado | 80218 | United States |
| BRCR Medical Center Inc. | Recruiting | Coral Springs | Florida | 33065 | United States |
| Mid Florida Hematology and Oncology Center | Recruiting | Orange City | Florida | 32763 | United States |
| Orlando Health Ambulatory Care Center | Recruiting | Orlando | Florida | 32806 | United States |
| Orlando Health Cancer Institute | Recruiting | Orlando | Florida | 32806 | United States |
| Orlando Health Orlando Regional Medical Center | Recruiting | Orlando | Florida | 32806 | United States |
| BRCR Global - Tamarac | Recruiting | Tamarac | Florida | 33321 | United States |
| Montefiore Medical Center- Montefiore Medical Park | Recruiting | The Bronx | New York | 10461 | United States |
| Oncology Associates of Oregon, P.C. | Recruiting | Eugene | Oregon | 97401 | United States |
| Dallas Cancer Specialists | Recruiting | Garland | Texas | 75042 | United States |
| Southwest Oncology Associates | Recruiting | Houston | Texas | 77030 | United States |
| Lumi Research | Recruiting | Houston | Texas | 77090 | United States |
| US Oncology Investigational Products Center (IPC) | Recruiting | Irving | Texas | 75063 | United States |
| Voyage Clinical | Recruiting | Sugar Land | Texas | 77479 | United States |
| VCU Medical Center Gateway Building | Recruiting | Richmond | Virginia | 23219 | United States |
| Virginia Commonwealth University | Recruiting | Richmond | Virginia | 23219 | United States |
| VCU Health Stony Point | Recruiting | Richmond | Virginia | 23235 | United States |
| Massey Cancer Center Clinical & Translational Research Lab | Recruiting | Richmond | Virginia | 23298 | United States |
| Virginia Commonwealth University | Recruiting | Richmond | Virginia | 23298 | United States |
| VCU Health Community Memorial Hospital | Recruiting | South Hill | Virginia | 23970 | United States |
| VCU Health Tappahannock Hospital | Recruiting | Tappahannock | Virginia | 22560 | United States |
| Beijing Cancer hospital | Not yet recruiting | Beijing | Beijing Municipality | 100142 | China |
| Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology | Not yet recruiting | Wuhan | Hubei | 430030 | China |
| Shanghai Chest Hospital | Not yet recruiting | Shanghai | Shanghai Municipality | 200030 | China |
| Taizhou Hospital of Zhejiang Province | Not yet recruiting | Taizhou | Zhejiang | 317000 | China |
| Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest | Not yet recruiting | Bordeaux | Aquitaine | 33076 | France |
| Centre Georges François Leclerc | Not yet recruiting | Dijon | CÔTE D'OR | 21079 | France |
| Institut Paoli-Calmettes | Recruiting | Marseille | Provence-Alpes-Côte d'Azur Region | 13273 | France |
| Marien Hospital Düsseldorf | Not yet recruiting | Düsseldorf | North Rhine-Westphalia | 40479 | Germany |
| Azienda Sanitaria Territoriale Pesaro Urbino (AST PU) | Not yet recruiting | Fano | Pesaro AND Urbino | 61032 | Italy |
| IRCCS Istituto Nazionale dei Tumori Regina Elena | Not yet recruiting | Roma | ROME | 00144 | Italy |
| Ospedale Isola Tiberina - Gemelli Isola | Not yet recruiting | Roma | ROME | 00186 | Italy |
| Kansai Medical University Hospital | Recruiting | Hirakata | Osaka | 573-1191 | Japan |
| Shizuoka Cancer Center | Recruiting | Nagaizumi-cho | Shizuoka | 411-8777 | Japan |
| Pan American Center for Oncology Trials, LLC | Recruiting | Rio Piedras | 00935 | Puerto Rico |
| BRCR Global Puerto Rico - Hato Rey | Recruiting | San Juan | 00917 | Puerto Rico |
| Hospital de la Santa Creu i Sant Pau | Not yet recruiting | Barcelona | Catalunya [cataluña] | 08041 | Spain |
| Hospital Nuestra Señora del Rosario | Recruiting | Madrid | Madrid, Comunidad de | 280006 | Spain |
| Hospital Universitario 12 de Octubre | Recruiting | Madrid | Madrid, Comunidad de | 28041 | Spain |
| Hospital Universitario San Cecilio | Recruiting | Granada | 18016 | Spain |
| Hospital Clinico San Carlos | Recruiting | Madrid | 28040 | Spain |
| Hospital Universitario Virgen Macarena | Not yet recruiting | Seville | 41009 | Spain |
| VIVO Capuchinos | Not yet recruiting | Seville | 41009 | Spain |
| Kaohsiung Medical University Chung-Ho Memorial Hospital | Recruiting | Kaohsiung City | 807 | Taiwan |
| Chang Gung Memorial Hospital at Kaohsiung | Recruiting | Kaohsiung City | 83301 | Taiwan |
| National Cheng Kung University Hospital | Recruiting | Tainan | 704 | Taiwan |
| National Taiwan University Hospital | Not yet recruiting | Taipei | 100 | Taiwan |
| Mackay Memorial Hospital | Recruiting | Taipei | 10449 | Taiwan |
| Taipei Veterans General Hospital | Recruiting | Taipei | 11217 | Taiwan |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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