Recruiting

Symbiotic-Lung-20: A Study to Learn About the Study Medicine Called PF-08634404 in Combination With Different Anticancer Agents in Advanced Cancers

NCT07227298 · Pfizer

Recruiting

In plain English

Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.

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

About this study

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 to other parts of the body 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 will test PF-08634404 with a medicine called PF-08046054/SGN-PDL1V 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.

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 for which there are available first-line therapies per local standard-of-care (SOC) * History of another malignancy within 2 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 or metastatic NSCLC * Previous treatment with immunotherapy (exception is (neo)adjuvant or consolidation anti-PD-(L)1), ADCs containing MMAE payload, systemic anti-angiogenic therapy, or prior radiotherapy \>30 Gy to the lung within 6 months of first dose of study intervention

Study design

Enrollment target: 162 participants

Allocation: non_randomized

Masking: none

Age groups: adult, older_adult

Timeline

Starts: 2026-01-30

Estimated completion: 2033-08-23

Last updated: 2026-09-11

Interventions

Biological: PF-08634404Biological: Sigvotatug VedotinBiological: PF-08046054/SGN-PDL1V

Primary outcomes

• Number of Participants with Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) (Through 90 days after the last study intervention; Up to approximately 5 years)
• Phase I: Number of participants with dose limiting toxicity (DLT) (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 (Up to approximately 5 Years)

Sponsor

Pfizer · industry

Contacts & investigators

ContactPfizer CT.gov Call Center · contact · ClinicalTrials.gov_Inquiries@pfizer.com · 1-800-718-1021

InvestigatorPfizer CT.gov Call Center · study_director, Pfizer

All locations (87)

Highlands Oncology Group, PARecruiting

Fayetteville, Arkansas, United States

Highlands Oncology Group, PARecruiting

Rogers, Arkansas, United States

Highlands Oncology Group, PARecruiting

Springdale, Arkansas, United States

Providence Medical FoundationRecruiting

Fullerton, California, United States

Providence St. Jude Medical Center - Virginia K. Crosson Cancer Center and Infusion CenterRecruiting

Fullerton, California, United States

Providence St. Jude Medical CenterRecruiting

Fullerton, California, United States

Scripps Clinic Torrey Pines (Scripps Cancer Center)Recruiting

La Jolla, California, United States

Scripps Green HospitalRecruiting

La Jolla, California, United States

Scripps Shiley PavilionRecruiting

La Jolla, California, United States

START Los Angeles, LLCRecruiting