臨床研究等提出・公開システム

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

A Study to Learn About the Study Medicine Called PF-08634404 in Combination With Different Anticancer Agents in Advanced Cancers

Kawai Norisuke

Pfizer R&D Japan G.K.

Shinjuku Bunka Quint Bldg., 3-22-7 Yoyogi, Shibuya-ku, Tokyo

clinical-trials@pfizer.com

Clinical Trials Information Desk

Pfizer R&D Japan G.K.

Shinjuku Bunka Quint Bldg., 3-22-7 Yoyogi, Shibuya-ku, Tokyo

+81-3-5309-7000

clinical-trials@pfizer.com

Pending

Jan. 30, 2026

Interventional

non-randomized controlled trial

open(masking not used)

active control

parallel assignment

treatment purpose

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

Both

*Advanced/Metastatic Non-Small Cell Lung Cancer

*Biological: PF-08634404
--Concentrate for solution for infusion
-Other Names:
#SSGJ-707
*Biological: Sigvotatug Vedotin
--Powder for concentrate for solution for infusion. Single use vial
-Other Names:
#SGN-B6A
#PF-08046047
*Biological: Combination Agent 1
--Powder for concentrate for solution for infusion. Single use vial.

*Number of Participants with Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) [Time Frame: Through 90 days after the last study intervention; Up to approximately 5 years]
-AEs as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), timing, seriousness, and relationship to study intervention.
*Phase I: Number of participants with dose limiting toxicity (DLT) [Time Frame: Through 90 days after the last study intervention; Up to approximately 5 years]
-Dose limiting toxicity based on dose limiting toxicity evaluable participants. The number of participants who experienced DLTs during the DLT observation period.
*Phase 2: Confirmed Objective Response Rate (ORR) per RECIST v1.1 by investigator [Time Frame: Up to approximately 5 Years]
-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.

*Phase I: Confirmed ORR per RECIST v1.1 by investigator [Time Frame: Up to approximately 5 Years]
-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.
*Disease Control Rate (DCR) per RECIST v1.1 by investigator [Time Frame: Up to approximately 5 years]
-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.
*Duration of Response (DOR) per RECIST v1.1 by investigator [Time Frame: Up to approximately 5 years]
-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.
*Progression Free Survival (PFS) per RECIST v1.1 by investigator [Time Frame: Up to approximately 5 years]
-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.
*Number of Participants With Clinical Laboratory Abnormalities [Time Frame: Through 90 days after the last study intervention; Up to approximately 5 years]
*Pharmacokinetics (PK): Serum concentration of PF-08634404 with anticancer agents [Time Frame: Up to 37 days after the last dose of treatment]
-To characterize the pharmacokinetics (PK) of PF-08634404 with anticancer agents.
*Incidence of Anti-Drug Antibody (ADA) against PF-08634404 with anticancer agents [Time Frame: Up to 37 days after the last dose of treatment]
-To characterize the immunogenicity of PF-08634404 with anticancer agents.

+81-3-6665-0572

Jan. 13, 2026

No

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.

Will be updated