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A study of PF-08634404 and sigvotatug vedotin in patients with advanced solid tumors

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on individuals with Advanced Solid Tumors, which are types of cancer that have spread or grown significantly in various parts of the body. The purpose of the study is to evaluate the safety and effectiveness of a new experimental drug called PF-08634404 when used alongside other cancer treatments. Specifically, the investigation involves combining this new drug with either sigvotatug vedotin or PF-08046054.

Participants in the study will receive these medications through intravenous infusion, which means the medicine is delivered directly into a vein. The research is divided into different stages to determine the safest and most effective dose of the medicine. During the first part, the focus is on how well the body tolerates the combination of drugs. The subsequent parts aim to see how well the treatments work to reduce the size or growth of the tumors.

The research process

The trial runs in 2 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Phase 1 safety run-in

    Participation in the safety run-in stage involves receiving pf-08634404 through an intravenous infusion (medicine delivered directly into a vein).

    This medicine is administered in combination with either sigvotatug vedotin or pf-08046054.

    During this stage, the focus is on monitoring for adverse events, which are side effects or health problems, and dose-limiting toxicities, which are severe side effects that may prevent further increasing the dose.

  2. Step 2

    Phase 2 dose optimization and expansion

    The next stage involves dose optimization and dose expansion to determine the most effective amount of medicine to use.

    The pf-08634404 is continued via intravenous infusion in combination with either sigvotatug vedotin or pf-08046054.

    The antitumor efficacy, which is how well the medicine works to shrink or stop the growth of tumors, is evaluated.

    The objective response rate, which measures the proportion of patients whose tumors shrink or disappear, is monitored by the medical team.

Who can join the trial?

11 criteria

  • You must be 18 years of age or older at the time of the initial evaluation.
  • You must have a confirmed diagnosis of non-small cell lung cancer (NSCLC), which is a common type of lung cancer. This cancer can be locally advanced (meaning it has grown into nearby tissues) or metastatic (meaning it has spread to other parts of the body).
  • The cancer must be either squamous or non-squamous in type, and you must not be a candidate for surgery to remove the entire tumor or for a combination of radiation and chemotherapy intended to cure the disease.
  • The cancer must not contain small cell elements or be a type called large cell neuroendocrine carcinoma.
  • You must have enough tumor tissue available, such as from a previous biopsy (a procedure to remove a small piece of tissue for testing), to be used for study analysis. This tissue must be in a specific format called FFPE cell blocks, which is a way of preserving tissue samples.
  • Your PD-L1 status must be known through local testing. For certain parts of the study, your PD-L1 (a protein found on some cancer cells) must be 1% or higher.
  • The cancer must be measurable, meaning it can be clearly seen and tracked on medical scans using specific standard rules called RECIST v1.1. If you have had radiation before, the measurable cancer must be in an area not previously treated by radiation or must show clear signs of growing.
  • You must have a good performance status, measured by the ECOG score, of 0 or 1. This means you are able to carry out daily activities and light work with little to no restriction.
  • It is expected that you will live for at least 12 weeks.
  • You must have adequate organ function, meaning your organs are working well. This includes having healthy blood counts (such as red blood cells and platelets) without needing recent treatments like blood transfusions or medications to boost blood cell production.
  • You must provide written informed consent, which means you agree to participate in the study after being fully informed about all the details.

Who cannot join the trial?

34 criteria

  • You cannot join if you have certain types of genetic mutations (changes in your DNA) in your tumor, such as EGFR, ALK, ROS1, NTRK, BRAF, RET, or MET, that can be treated with currently available standard medicines.
  • You are not eligible if you have had uncontrolled health problems in the last 6 months, such as:
    • Unstable angina (chest pain that happens unexpectedly or is not controlled).
    • Myocardial infarction (a heart attack).
    • Arrhythmia (an irregular heartbeat), including dangerous types like ventricular fibrillation (where the heart quivers instead of pumping).
    • Problems with the heart's electrical system, such as conduction abnormalities (interruptions in the electrical signals that make the heart beat).
    • Having had bypass surgery on your heart or arteries.
    • A transient ischemic attack (a "mini-stroke"), a cerebrovascular accident (a full stroke), or a cerebral hemorrhage (bleeding in the brain).
    • Congestive heart failure (a condition where the heart cannot pump blood well enough to meet the body's needs).
    • Liver cirrhosis (severe scarring of the liver) that is not stable.
    • Nephrotic syndrome (a kidney disorder that causes the body to pass too much protein in the urine).
    • Uncontrolled diabetes (high blood sugar that is not managed by medicine or lifestyle).
    • Uncontrolled hypertension (high blood pressure that is not within a healthy range).
    • Severe blood clots in the arteries or veins.
    • A hypertensive crisis (a sudden, severe increase in blood pressure).
    • You cannot participate if your ECG (a test that records the electrical activity of your heart) shows a QTcF interval longer than 480 milliseconds, which is a measurement of the time it takes for your heart muscle to recharge between beats.
    • You are excluded if you had major surgery or a severe injury in the last 4 weeks, or if you have a planned major surgery during the study.
    • You cannot join if you have pleural effusion (fluid around the lungs), pericardial effusion (fluid around the heart), or ascites (fluid buildup in the abdomen) that causes symptoms or requires frequent drainage.
    • You are ineligible if you have a history of severe bleeding problems, such as gastrointestinal bleeding (bleeding in the stomach or intestines) or hemoptysis (coughing up blood).
    • You cannot participate if you have had certain stomach or intestinal issues in the last 6 months, such as esophageal varices (swollen veins in the throat), ulcers, perforation (a hole in the digestive tract), or obstruction (a blockage).
    • You are excluded if you have an active infection, such as a viral, bacterial, or fungal infection, or if you have certain infections like HIV, Hepatitis B (HBV), Hepatitis C (HCV), or Tuberculosis (TB), unless they are stable and meet specific rules.
    • You cannot join if you have a history of immunodeficiency (a weakened immune system).
    • You are excluded if you have a history of severe allergies to the study medicine or to antibodies (proteins used in certain treatments).
    • You cannot participate if you have certain mental health conditions, such as suicidal ideation (thoughts of suicide) in the past year or suicidal behavior in the past 5 years.
    • You are ineligible if you have active cancer in the central nervous system (the brain or spinal cord), such as metastases (cancer that has spread from another part of the body).
    • You cannot join if you have had other cancers within the last 3 years, unless they are low-risk types like certain skin cancers.
    • You are excluded if you have unresolved side effects from previous cancer treatments that have not improved.
    • You cannot participate if you have had an organ transplant or a stem cell transplant.
    • You are ineligible if you have active autoimmune diseases (conditions where the immune system attacks the body) that require medicine, such as certain inflammatory conditions.
    • You cannot join if you have certain lung conditions, such as interstitial lung disease (ILD) (scarring or inflammation of lung tissue) or severe asthma or COPD (chronic obstructive pulmonary disease).
    • You are excluded if you have taken certain blood-thinning medicines (anticoagulants) or antiplatelet drugs (like aspirin) very recently.
    • You cannot participate if you have received a live vaccine in the last 4 weeks.
    • You are ineligible if you are currently using high-dose steroids or other medicines that suppress the immune system.
    • You cannot join if you are breastfeeding, or if you are a person of childbearing age or a male who is unwilling to use contraception (birth control).
    • You are excluded if you are a staff member involved in the study or a family member of the staff.
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Investigated drugs

  • Sigvotatug vedotin

    is a type of drug that is given through a vein. It is designed to target specific markers on cancer cells to help deliver treatment directly to the tumor.

  • PF-08634404

    is an experimental medication administered through an intravenous infusion. It is being studied to see how well it works when used in combination with other anticancer treatments for people with advanced solid tumors.

What is already known about the treatment

  • Sigvotatug vedotin

    This experimental drug is delivered as a powder that is mixed into a liquid and administered through a vein. Currently being studied in clinical trials, it is designed to treat advanced solid tumors. It works as an antibody-drug conjugate, which means it uses a specialized protein to find cancer cells and then releases a powerful toxic substance directly inside them to destroy the tumor.

  • PF-08634404

    This medication is provided as a concentrated liquid and is administered directly into the bloodstream through an intravenous infusion. It is an investigational substance currently undergoing testing for the treatment of various advanced solid tumors. As a targeted therapy, it is designed to seek out specific markers on cancer cells to interfere with their growth and survival at a molecular level.

  • Humanised IgG1 monoclonal antibody against PD-L1 conjugated to monomethyl auristatin E via a valine-citrulline linker

    This experimental treatment is supplied as a freeze-dried powder that is prepared for injection into a vein. It is currently in the research phase and is being studied for its ability to treat advanced solid tumors. This drug belongs to a class called antibody-drug conjugates, which works by using a laboratory-made antibody to attach itself to a protein on the surface of cancer cells, subsequently delivering a potent cell-killing agent directly to the tumor.

Investigated diseases

Solid tumor - A solid tumor is a type of mass or growth made up of abnormal cells that form a solid lump in the body. These growths often originate in healthy tissues and can expand as the cells multiply uncontrollably. As the condition progresses, these abnormal cells may invade nearby tissues or spread to other parts of the body. The development of these tumors involves a continuous cycle of cell division that disrupts normal bodily functions.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase ITrial ID2025-523526-40-00Protocol codeC6461020Estimated enrolment162 patientsSponsorPfizer Inc.

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).