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RecruitingInterventionalPhase 1/Phase 2

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

NCT ID: NCT07227298Sponsor: PfizerLast updated: 2026-06-04

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.

Arms & interventions

  • BiologicalPF-08634404

    -Concentrate for solution for infusion

  • BiologicalSigvotatug Vedotin

    -Powder for concentrate for solution for infusion. Single use vial

  • BiologicalCombination Agent 1

    -Powder for concentrate for solution for infusion. Single use vial.

Outcome measures

Primary

  • Number of Participants with Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)

    AEs as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), timing, seriousness, and relationship to study intervention.

    Time frame: Through 90 days after the last study intervention; Up to approximately 5 years

  • Phase I: Number of participants with dose limiting toxicity (DLT)

    Dose limiting toxicity based on dose limiting toxicity evaluable participants. The number of participants who experienced DLTs during the DLT observation period.

    Time frame: 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

    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.

    Time frame: Up to approximately 5 Years

Secondary

  • Phase I: Confirmed ORR per RECIST v1.1 by investigator

    Time frame: Up to approximately 5 Years

  • Disease Control Rate (DCR) per RECIST v1.1 by investigator

    Time frame: Up to approximately 5 years

  • Duration of Response (DOR) per RECIST v1.1 by investigator

    Time frame: Up to approximately 5 years

  • Progression Free Survival (PFS) per RECIST v1.1 by investigator

    Time frame: Up to approximately 5 years

  • 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

  • Incidence of Anti-Drug Antibody (ADA) against PF-08634404 with anticancer agents

    Time frame: Up to 37 days after the last dose of treatment

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy 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 locations (27)

Highlands Oncology Group, PA

Fayetteville, Arkansas, 72703

Recruiting

Highlands Oncology Group, PA

Rogers, Arkansas, 72758

Recruiting

Highlands Oncology Group, PA

Springdale, Arkansas, 72762

Recruiting

Providence Medical Foundation

Fullerton, California, 92835

Recruiting

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

Fullerton, California, 92835

Recruiting

Providence St. Jude Medical Center

Fullerton, California, 92835

Recruiting

Rocky Mountain Cancer Centers, LLP

Denver, Colorado, 80218

Recruiting

BRCR Medical Center Inc.

Coral Springs, Florida, 33065

Recruiting

Mid Florida Hematology and Oncology Center

Orange City, Florida, 32763

Recruiting

Orlando Health Ambulatory Care Center

Orlando, Florida, 32806

Recruiting

Orlando Health Cancer Institute

Orlando, Florida, 32806

Recruiting

Orlando Health Orlando Regional Medical Center

Orlando, Florida, 32806

Recruiting

BRCR Global - Tamarac

Tamarac, Florida, 33321

Recruiting

Montefiore Medical Center- Montefiore Medical Park

The Bronx, New York, 10461

Recruiting

Oncology Associates of Oregon, P.C.

Eugene, Oregon, 97401

Recruiting

Dallas Cancer Specialists

Garland, Texas, 75042

Recruiting

Southwest Oncology Associates

Houston, Texas, 77030

Recruiting

Lumi Research

Houston, Texas, 77090

Recruiting

US Oncology Investigational Products Center (IPC)

Irving, Texas, 75063

Recruiting

Voyage Clinical

Sugar Land, Texas, 77479

Recruiting

VCU Medical Center Gateway Building

Richmond, Virginia, 23219

Recruiting

Virginia Commonwealth University

Richmond, Virginia, 23219

Recruiting

VCU Health Stony Point

Richmond, Virginia, 23235

Recruiting

Massey Cancer Center Clinical & Translational Research Lab

Richmond, Virginia, 23298

Recruiting

Virginia Commonwealth University

Richmond, Virginia, 23298

Recruiting

VCU Health Community Memorial Hospital

South Hill, Virginia, 23970

Recruiting

VCU Health Tappahannock Hospital

Tappahannock, Virginia, 22560

Recruiting