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

June 3, 2026 updated by: Pfizer

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

162

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100142
        • Not yet recruiting
        • Beijing Cancer Hospital
    • Hubei
      • Wuhan, Hubei, China, 430030
        • Not yet recruiting
        • Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology
    • Zhejiang
      • Taizhou, Zhejiang, China, 317000
        • Not yet recruiting
        • Taizhou Hospital of Zhejiang Province
  • Italy
    • Pesaro AND Urbino
      • Fano, Pesaro AND Urbino, Italy, 61032
        • Not yet recruiting
        • Azienda Sanitaria Territoriale Pesaro Urbino (AST PU)
    • ROME
      • Roma, ROME, Italy, 00144
        • Not yet recruiting
        • IRCCS Istituto Nazionale dei Tumori Regina Elena
      • Roma, ROME, Italy, 00186
        • Not yet recruiting
        • Ospedale Isola Tiberina - Gemelli Isola
  • Japan
    • Osaka
      • Hirakata, Osaka, Japan, 573-1191
        • Recruiting
        • Kansai Medical University Hospital
    • Shizuoka
      • Nagaizumi-cho, Shizuoka, Japan, 411-8777
        • Recruiting
        • Shizuoka Cancer Center
  • Puerto Rico
      • Rio Piedras, Puerto Rico, 00935
        • Recruiting
        • Pan American Center for Oncology Trials, LLC
      • San Juan, Puerto Rico, 00917
        • Recruiting
        • BRCR Global Puerto Rico - Hato Rey
  • Spain
      • Granada, Spain, 18016
        • Not yet recruiting
        • Hospital Universitario San Cecilio
    • Catalunya [cataluña]
      • Barcelona, Catalunya [cataluña], Spain, 08041
        • Not yet recruiting
        • Hospital De La Santa Creu I Sant Pau
  • Taiwan
      • Kaohsiung City, Taiwan, 807
        • Recruiting
        • Kaohsiung Medical University Chung-Ho Memorial Hospital
      • Kaohsiung City, Taiwan, 83301
        • Recruiting
        • Chang Gung Memorial Hospital at Kaohsiung
      • Tainan, Taiwan, 704
        • Recruiting
        • National Cheng Kung University Hospital
      • Taipei, Taiwan, 10449
        • Recruiting
        • Mackay Memorial Hospital
      • Taipei, Taiwan, 100
        • Not yet recruiting
        • National Taiwan University Hospital
      • Taipei, Taiwan, 11217
        • Recruiting
        • Taipei Veterans General Hospital
  • United States
    • Arkansas
      • Fayetteville, Arkansas, United States, 72703
        • Recruiting
        • Highlands Oncology Group, PA
      • Rogers, Arkansas, United States, 72758
        • Recruiting
        • Highlands Oncology Group, PA
      • Springdale, Arkansas, United States, 72762
        • Recruiting
        • Highlands Oncology Group, PA
    • California
      • Fullerton, California, United States, 92835
        • Recruiting
        • Providence Medical Foundation
      • Fullerton, California, United States, 92835
        • Recruiting
        • Providence St. Jude Medical Center
      • Fullerton, California, United States, 92835
        • Recruiting
        • Providence St. Jude Medical Center - Virginia K. Crosson Cancer Center and Infusion Center
    • Colorado
      • Denver, Colorado, United States, 80218
        • Recruiting
        • Rocky Mountain Cancer Centers, LLP
    • Florida
      • Coral Springs, Florida, United States, 33065
        • Recruiting
        • BRCR Medical Center Inc.
      • Orange City, Florida, United States, 32763
        • Recruiting
        • Mid Florida Hematology and Oncology Center
      • Orlando, Florida, United States, 32806
        • Recruiting
        • Orlando Health Cancer Institute
      • Orlando, Florida, United States, 32806
        • Recruiting
        • Orlando Health Orlando Regional Medical Center
      • Orlando, Florida, United States, 32806
        • Recruiting
        • Orlando Health Ambulatory Care Center
      • Tamarac, Florida, United States, 33321
        • Recruiting
        • BRCR Global - Tamarac
    • New York
      • The Bronx, New York, United States, 10461
        • Recruiting
        • Montefiore Medical Center- Montefiore Medical Park
    • Oregon
      • Eugene, Oregon, United States, 97401
        • Recruiting
        • Oncology Associates of Oregon, P.C.
    • Texas
      • Garland, Texas, United States, 75042
        • Recruiting
        • Dallas Cancer Specialists
      • Houston, Texas, United States, 77090
        • Recruiting
        • Lumi Research
      • Houston, Texas, United States, 77030
        • Recruiting
        • Southwest Oncology Associates
      • Irving, Texas, United States, 75063
        • Recruiting
        • US Oncology Investigational Products Center (IPC)
      • Sugar Land, Texas, United States, 77479
        • Recruiting
        • Voyage Clinical
    • Virginia
      • Richmond, Virginia, United States, 23298
        • Recruiting
        • Virginia Commonwealth University
      • Richmond, Virginia, United States, 23219
        • Recruiting
        • Virginia Commonwealth University
      • Richmond, Virginia, United States, 23219
        • Recruiting
        • VCU Medical Center Gateway Building
      • Richmond, Virginia, United States, 23235
        • Recruiting
        • VCU Health Stony Point
      • Richmond, Virginia, United States, 23298
        • Recruiting
        • Massey Cancer Center Clinical & Translational Research Lab
      • South Hill, Virginia, United States, 23970
        • Recruiting
        • VCU Health Community Memorial Hospital
      • Tappahannock, Virginia, United States, 22560
        • Recruiting
        • VCU Health Tappahannock Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Through 90 days after the last study intervention; Up to approximately 5 years
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.
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
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.
Up to approximately 5 Years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to approximately 5 Years
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.
Up to approximately 5 years
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.
Up to approximately 5 years
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.
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
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.
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
To characterize the immunogenicity of PF-08634404 with anticancer agents.
Up to 37 days after the last dose of treatment

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival (OS)
Time Frame: Up to approximately 5 years
Overall survival defined as the time from the date of randomization to the date of death due to any cause.
Up to approximately 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Investigators

  • Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 30, 2026

Primary Completion (Estimated)

March 8, 2029

Study Completion (Estimated)

August 23, 2033

Study Registration Dates

First Submitted

November 7, 2025

First Submitted That Met QC Criteria

November 10, 2025

First Posted (Actual)

November 12, 2025

Study Record Updates

Last Update Posted (Actual)

June 4, 2026

Last Update Submitted That Met QC Criteria

June 3, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C6461020
  • 2025-523526-40-00 (Ctis)
  • Symbiotic-Lung-20 (Other Identifier: Pfizer)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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