A Study to Learn About the Study Medicine Called PF-08634404 in Combination With Different Anticancer Agents in Advanced Cancers
NCT ID: NCT07227298
Last Updated: 2025-11-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE1/PHASE2
162 participants
INTERVENTIONAL
2025-11-17
2033-08-23
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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PF-08634404 + Combination Agent 1 (Part B)
Participants will receive PF-08634404 in combination with other anticancer agent as per protocol.
PF-08634404
-Concentrate for solution for infusion
Combination Agent 1
-Powder for concentrate for solution for infusion. Single use vial.
PF-08634404 + Sigvotatug Vedotin (Part A)
Participants will receive PF-08634404 in combination with Sigvotatug Vedotin.
PF-08634404
-Concentrate for solution for infusion
Sigvotatug Vedotin
-Powder for concentrate for solution for infusion. Single use vial
Interventions
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PF-08634404
-Concentrate for solution for infusion
Sigvotatug Vedotin
-Powder for concentrate for solution for infusion. Single use vial
Combination Agent 1
-Powder for concentrate for solution for infusion. Single use vial.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Central Contacts
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Other Identifiers
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2025-523526-40-00
Identifier Type: CTIS
Identifier Source: secondary_id
C6461020
Identifier Type: -
Identifier Source: org_study_id