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NCT Number: NCT07227298

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

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.

Recruiting

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Key information

Conditions

Advanced/Metastatic Non-Small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Carcinoma, Non-small Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Non-small Cell Lung Cancer Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Beijing Cancer hospital, Beijing, Beijing Municipality, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PF-08634404

Biological

-Concentrate for solution for infusion

Other names: SSGJ-707

Sigvotatug Vedotin

Biological

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

Other names: SGN-B6A, PF-08046047

Combination Agent 1

Biological

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

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. Number of Participants With Clinical Laboratory Abnormalities

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

  6. 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.

  7. 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.

Other outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Pfizer CT.gov Call Center

CONTACT

[email protected]

1-800-718-1021

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2029
Study completion
2033
First posted
Nov 12, 2025
Registry last updated
Jul 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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