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Purpose

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.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 1/Phase 2
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Sequential Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
PF-08634404 + Sigvotatug Vedotin (Part A) 		Participants will receive PF-08634404 in combination with Sigvotatug Vedotin.
  • 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
Experimental
PF-08634404 + Combination Agent 1 (Part B) 		Participants will receive PF-08634404 in combination with other anticancer agents as per protocol.
  • Biological: PF-08634404
    -Concentrate for solution for infusion
    Other names:
    • SSGJ-707
  • Biological: Combination Agent 1
    -Powder for concentrate for solution for infusion. Single use vial.

Recruiting Locations

Highlands Oncology Group, PA
Fayetteville, Arkansas 72703

Highlands Oncology Group, PA
Rogers, Arkansas 72758

Highlands Oncology Group, PA
Springdale, Arkansas 72762

Providence Medical Foundation
Fullerton, California 92835

Providence St. Jude Medical Center - Virginia K. Crosson Cancer Center and Infusion Center
Fullerton, California 92835

Providence St. Jude Medical Center
Fullerton, California 92835

Rocky Mountain Cancer Centers, LLP
Denver, Colorado 80218

BRCR Medical Center Inc.
Coral Springs, Florida 33065

Mid Florida Hematology and Oncology Center
Orange City, Florida 32763

BRCR Global - Tamarac
Tamarac, Florida 33321

Oncology Associates of Oregon, P.C.
Eugene, Oregon 97401

US Oncology Investigational Products Center (IPC)
Irving, Texas 75063

VCU Medical Center Gateway Building
Richmond, Virginia 23219

Virginia Commonwealth University
Richmond, Virginia 23219

VCU Health Stony Point
Richmond, Virginia 23235

Massey Cancer Center Clinical & Translational Research Lab
Richmond, Virginia 23298

Virginia Commonwealth University
Richmond, Virginia 23298

VCU Health Community Memorial Hospital
South Hill, Virginia 23970

VCU Health Tappahannock Hospital
Tappahannock, Virginia 22560

Pan American Center for Oncology Trials, LLC
Rio Piedras, Puerto Rico 00935

BRCR Global Puerto Rico - Hato Rey
San Juan, Puerto Rico 00917

More Details

Status
Recruiting
Sponsor
Pfizer

Study Contact

Pfizer CT.gov Call Center
1-800-718-1021
ClinicalTrials.gov_Inquiries@pfizer.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.