Brief Summary
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:
* Be 18 years or older
* Participants with advanced non-small cell lung cancer (NSCLC), a type of lung cancer that has spread
The study will look at:
* Whether PF-08634404 is safe to use with other cancer medicines.
* What side effects may happen. A side effect is anything the medicine does to your body that is not part of treating your disease.
* Whether the combination of PF-08634404 and other cancer medicines can help treat solid tumors.
The study has different parts, each testing PF-08634404 with a different cancer medicine:
* Part A will test PF-08634404 with a medicine called sigvotatug vedotin.
* Part B of the study will look at how well the new medicine PF-08634404 works when used together with another 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.
To join in the study, participants must:
* Be 18 years or older
* Participants with advanced non-small cell lung cancer (NSCLC), a type of lung cancer that has spread
The study will look at:
* Whether PF-08634404 is safe to use with other cancer medicines.
* What side effects may happen. A side effect is anything the medicine does to your body that is not part of treating your disease.
* Whether the combination of PF-08634404 and other cancer medicines can help treat solid tumors.
The study has different parts, each testing PF-08634404 with a different cancer medicine:
* Part A will test PF-08634404 with a medicine called sigvotatug vedotin.
* Part B of the study will look at how well the new medicine PF-08634404 works when used together with another 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.
Brief Title
Symbiotic-Lung-20: A Study to Learn About the Study Medicine Called PF-08634404 in Combination With Different Anticancer Agents in Advanced Cancers
Central Contacts
Central Contact Role
Contact
Central Contact Phone
1-800-718-1021
Central Contact Email
ClinicalTrials.gov_Inquiries@pfizer.com
Completion Date
Completion Date Type
Estimated
Conditions
ADVANCED/METASTATIC NON-SMALL CELL LUNG CANCER
CARCINOMA, NON-SMALL CELL LUNG
NON-SMALL CELL LUNG CANCER
Eligibility Criteria
Inclusion Criteria:
* Pathologically confirmed locally advanced (Stage IIIB/IIIC) or metastatic (Stage IV) squamous or non-squamous NSCLC and are not a candidate for complete surgical resection and curative concurrent/sequential chemoradiotherapy
* PD-L1 status available
* Part B only: PD-L1 ≥ TPS 1%
* Measurable disease based on RECIST v1.1 per investigator.
* Eastern Cooperative Oncology Group performance status of 0 or 1.
* Adequate organ function
Exclusion Criteria:
* Participants with known AGAs including EGFR, ALK and ROS1, NTRK, BRAF, and MET
* History of another malignancy within 3 years before the first dose of study intervention, or any evidence of residual disease from a previously diagnosed malignancy
* Known active CNS lesions, including brainstem, meningeal, or spinal cord metastases or compression
* Leptomeningeal disease
* Active autoimmune diseases requiring systemic treatment within the past 2 years
* Previous systemic anti-tumor therapy for locally advanced, unresectable, or metastatic NSCLC
* Previous treatment with immunotherapy (exception is (neo)adjuvant anti-PD-(L)1), ADCs containing MMAE payload, systemic anti-angiogenic therapy, or prior radiotherapy to the lung within 6 months of first dose of study intervention
* Pathologically confirmed locally advanced (Stage IIIB/IIIC) or metastatic (Stage IV) squamous or non-squamous NSCLC and are not a candidate for complete surgical resection and curative concurrent/sequential chemoradiotherapy
* PD-L1 status available
* Part B only: PD-L1 ≥ TPS 1%
* Measurable disease based on RECIST v1.1 per investigator.
* Eastern Cooperative Oncology Group performance status of 0 or 1.
* Adequate organ function
Exclusion Criteria:
* Participants with known AGAs including EGFR, ALK and ROS1, NTRK, BRAF, and MET
* History of another malignancy within 3 years before the first dose of study intervention, or any evidence of residual disease from a previously diagnosed malignancy
* Known active CNS lesions, including brainstem, meningeal, or spinal cord metastases or compression
* Leptomeningeal disease
* Active autoimmune diseases requiring systemic treatment within the past 2 years
* Previous systemic anti-tumor therapy for locally advanced, unresectable, or metastatic NSCLC
* Previous treatment with immunotherapy (exception is (neo)adjuvant anti-PD-(L)1), ADCs containing MMAE payload, systemic anti-angiogenic therapy, or prior radiotherapy to the lung within 6 months of first dose of study intervention
Inclusion Criteria
Inclusion Criteria:
* Pathologically confirmed locally advanced (Stage IIIB/IIIC) or metastatic (Stage IV) squamous or non-squamous NSCLC and are not a candidate for complete surgical resection and curative concurrent/sequential chemoradiotherapy
* PD-L1 status available
* Part B only: PD-L1 ≥ TPS 1%
* Measurable disease based on RECIST v1.1 per investigator.
* Eastern Cooperative Oncology Group performance status of 0 or 1.
* Adequate organ function
* Pathologically confirmed locally advanced (Stage IIIB/IIIC) or metastatic (Stage IV) squamous or non-squamous NSCLC and are not a candidate for complete surgical resection and curative concurrent/sequential chemoradiotherapy
* PD-L1 status available
* Part B only: PD-L1 ≥ TPS 1%
* Measurable disease based on RECIST v1.1 per investigator.
* Eastern Cooperative Oncology Group performance status of 0 or 1.
* Adequate organ function
Gender
All
Gender Based
false
Keywords
non-small cell lung cancer
NSCLC
advanced solid tumors
metastatic non-small cell lung cancer
locally advanced non-small cell lung cancer
squamous non-small cell lung cancer
non-squamous non-small cell lung cancer
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT07227298
Org Class
Industry
Org Full Name
Pfizer
Org Study Id
C6461020
Overall Status
Recruiting
Phases
Phase 1
Phase 2
Primary Completion Date
Primary Completion Date Type
Estimated
Official Title
AN INTERVENTIONAL OPEN-LABEL PHASE 1B/2 STUDY TO EVALUATE THE SAFETY, PHARMACOKINETICS, AND PRELIMINARY EFFICACY OF PF-08634404 IN COMBINATION WITH DIFFERENT ANTICANCER AGENTS IN PARTICIPANTS WITH ADVANCED SOLID TUMORS
Primary Outcomes
Outcome Description
AEs as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), timing, seriousness, and relationship to study intervention.
Outcome Measure
Number of Participants with Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Outcome Time Frame
Through 90 days after the last study intervention; Up to approximately 5 years
Outcome Description
Dose limiting toxicity based on dose limiting toxicity evaluable participants. The number of participants who experienced DLTs during the DLT observation period.
Outcome Measure
Phase I: Number of participants with dose limiting toxicity (DLT)
Outcome Time Frame
Through 90 days after the last study intervention; Up to approximately 5 years
Outcome Description
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.
Outcome Measure
Phase 2: Confirmed Objective Response Rate (ORR) per RECIST v1.1 by investigator
Outcome Time Frame
Up to approximately 5 Years
Secondary Ids
Secondary Id
2025-523526-40-00
Secondary Id
Symbiotic-Lung-20
Secondary Outcomes
Outcome Description
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.
Outcome Time Frame
Up to approximately 5 Years
Outcome Measure
Phase I: Confirmed ORR per RECIST v1.1 by investigator
Outcome Description
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.
Outcome Time Frame
Up to approximately 5 years
Outcome Measure
Disease Control Rate (DCR) per RECIST v1.1 by investigator
Outcome Description
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.
Outcome Time Frame
Up to approximately 5 years
Outcome Measure
Duration of Response (DOR) per RECIST v1.1 by investigator
Outcome Description
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.
Outcome Time Frame
Up to approximately 5 years
Outcome Measure
Progression Free Survival (PFS) per RECIST v1.1 by investigator
Outcome Time Frame
Through 90 days after the last study intervention; Up to approximately 5 years
Outcome Measure
Number of Participants With Clinical Laboratory Abnormalities
Outcome Description
To characterize the pharmacokinetics (PK) of PF-08634404 with anticancer agents.
Outcome Time Frame
Up to 37 days after the last dose of treatment
Outcome Measure
Pharmacokinetics (PK): Serum concentration of PF-08634404 with anticancer agents
Outcome Description
To characterize the immunogenicity of PF-08634404 with anticancer agents.
Outcome Time Frame
Up to 37 days after the last dose of treatment
Outcome Measure
Incidence of Anti-Drug Antibody (ADA) against PF-08634404 with anticancer agents
See Also Links
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Haiying Cheng
Investigator Email
HCHENG@montefiore.org
Investigator Phone
718-405-8404
Investigator Department
Medicine
Investigator Division
Oncology
Investigator Sponsor Organization
External
Study Department
Oncology (Medical/Hematologic)
Study Division
Medical and Hematologic Oncology
Categories Mesh Debug
Lung & Chest Cancers --- CARCINOMA, NON-SMALL-CELL LUNG
Lung & Chest Cancers --- CARCINOMA, BRONCHOGENIC
Lung & Chest Cancers --- BRONCHIAL NEOPLASMS
Lung & Chest Cancers --- LUNG NEOPLASMS
Lung & Chest Cancers --- RESPIRATORY TRACT NEOPLASMS
Lung & Chest Cancers --- THORACIC NEOPLASMS
Cancer --- NEOPLASMS BY SITE
Cancer --- NEOPLASMS
COVID-19 --- LUNG DISEASES
Lung --- LUNG DISEASES
Asthma and Other Respiratory Diseases --- RESPIRATORY TRACT DISEASES
COVID-19 --- RESPIRATORY TRACT DISEASES
Lung --- RESPIRATORY TRACT DISEASES
MeSH Terms
CARCINOMA, NON-SMALL-CELL LUNG
CARCINOMA, BRONCHOGENIC
BRONCHIAL NEOPLASMS
LUNG NEOPLASMS
RESPIRATORY TRACT NEOPLASMS
THORACIC NEOPLASMS
NEOPLASMS BY SITE
NEOPLASMS
LUNG DISEASES
RESPIRATORY TRACT DISEASES