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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

Status: Recruiting
Location: See all (25) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
Arkansas
Highlands Oncology Group, PA
RECRUITING
Fayetteville
Highlands Oncology Group, PA
RECRUITING
Rogers
Highlands Oncology Group, PA
RECRUITING
Springdale
California
Providence Medical Foundation
NOT_YET_RECRUITING
Fullerton
Providence St. Jude Medical Center
NOT_YET_RECRUITING
Fullerton
Providence St. Jude Medical Center - Virginia K. Crosson Cancer Center and Infusion Center
NOT_YET_RECRUITING
Fullerton
Colorado
Rocky Mountain Cancer Centers, LLP
RECRUITING
Denver
Florida
BRCR Medical Center Inc.
RECRUITING
Coral Springs
Mid Florida Hematology and Oncology Center
RECRUITING
Orange City
BRCR Global - Tamarac
RECRUITING
Tamarac
Oregon
Oncology Associates of Oregon, P.C.
RECRUITING
Eugene
Texas
US Oncology Investigational Products Center (IPC)
RECRUITING
Irving
Virginia
Massey Cancer Center Clinical & Translational Research Lab
RECRUITING
Richmond
VCU Health Stony Point
RECRUITING
Richmond
VCU Medical Center Gateway Building
RECRUITING
Richmond
Virginia Commonwealth University
RECRUITING
Richmond
Virginia Commonwealth University
RECRUITING
Richmond
VCU Health Community Memorial Hospital
RECRUITING
South Hill
VCU Health Tappahannock Hospital
RECRUITING
Tappahannock
Other Locations
Japan
Kansai Medical University Hospital
RECRUITING
Hirakata
Puerto Rico
Pan American Center for Oncology Trials, LLC
RECRUITING
Rio Piedras
BRCR Global Puerto Rico - Hato Rey
RECRUITING
San Juan
Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital
NOT_YET_RECRUITING
Kaohsiung City
National Cheng Kung University Hospital
NOT_YET_RECRUITING
Tainan
National Taiwan University Hospital
NOT_YET_RECRUITING
Taipei
Contact Information
Primary
Pfizer CT.gov Call Center
ClinicalTrials.gov_Inquiries@pfizer.com
1-800-718-1021
Time Frame
Start Date: 2026-01-30
Estimated Completion Date: 2033-08-23
Participants
Target number of participants: 162
Treatments
Experimental: PF-08634404 + Sigvotatug Vedotin (Part A)
Participants will receive PF-08634404 in combination with Sigvotatug Vedotin.
Experimental: PF-08634404 + Combination Agent 1 (Part B)
Participants will receive PF-08634404 in combination with other anticancer agents as per protocol.
Sponsors
Leads: Pfizer

This content was sourced from clinicaltrials.gov