A Phase 1 Study of PF-08046052/SGN-EGFRd2 in Advanced Solid Tumors

Phase 1 trial tests new drug PF-08046052/SGN-EGFRd2 in advanced cancers

NCT: NCT05983133 · Status: ACTIVE NOT RECRUITING · Phase: Phase 1 · Sponsor: Seagen, a wholly owned subsidiary of Pfizer · Started: 2023-11-14 · Est. Completion: 2026-08-14

Plain English Summary

A Study of PF-08046052/SGN-EGFRd2 in Advanced Solid Tumors is a Phase 1 clinical trial sponsored by Seagen, a wholly owned subsidiary of Pfizer studying Colorectal Neoplasms, Carcinoma, Non-Small-Cell Lung, Squamous Cell Carcinoma of the Head and Neck, Pancreatic Ductal Adenocarcinoma. This study is testing the safety and side effects of a new drug called PF-08046052/SGN-EGFRd2. It is for adults with advanced solid tumors, including colorectal, lung, head and neck, and pancreatic cancers, that have not responded to standard treatments. Participants will receive the study drug intravenously (by IV) in cycles, and will undergo regular check-ups and tests. There are no alternative treatments offered within this study; standard treatments may have been exhausted for participants. The trial aims to enroll 68 participants.

Official Summary

This study will test the safety of a drug called PF-08046052/SGN-EGFRd2 in participants with advanced solid tumors. It will also study the side effects of this drug. A side effect is anything a drug does to the body besides treating the disease. Participants will have cancer that cannot be removed (unresectable) or has spread through the body (metastatic). This study will have three parts. Parts A and B of the study will find out how much PF-08046052/SGN-EGFRd2 should be given to participants. Part C will use the dose found in parts A and B to find out how safe PF-08046052/SGN-EGFRd2 is and if it works to treat solid tumor cancers.

Who Can Participate

Here is what you need to know about eligibility for this trial. Adults with advanced colorectal, non-small cell lung, or head and neck squamous cell cancers (excluding nasopharyngeal type) or pancreatic ductal adenocarcinoma. Patients whose cancer has spread or cannot be removed, and who have not responded to or cannot tolerate standard treatments. Must be able to provide tumor tissue and undergo biopsies if possible, and have a good general health status (ECOG score of 0 or 1). Cannot have active brain metastases, other recent cancers, or a history of blood clots within the last 6 months. This trial is studying Colorectal Neoplasms, Carcinoma, Non-Small-Cell Lung, Squamous Cell Carcinoma of the Head and Neck, Pancreatic Ductal Adenocarcinoma, so participants generally need a confirmed diagnosis.

What They're Measuring

The primary outcomes measure the safety of the drug by tracking how many participants experience side effects and dose-limiting toxicities, helping doctors understand how much of the drug can be safel The specific primary outcome measures are: Number of participants with adverse events (AEs) (Through 90 days after last study treatment, up to approximately 1 year); Number of participants with laboratory abnormalities (Through 30-37 days after last study treatment, up to approximately 1 year); Number of participants with dose limiting toxicities (DLTs) (Up to 35 days); Number of participants with DLTs by dose level (Up to 35 days). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This trial is in Phase 1, the first major stage of clinical testing. Phase 1 trials typically involve 20-100 participants and focus on safety, dosage levels, and side effects. The primary goal is not to test whether the treatment works but to establish that it is safe enough for further testing. About 70% of Phase 1 drugs advance to Phase 2. If successful, the treatment will proceed to Phase 2 efficacy testing.

Why This Trial Matters

This trial addresses a critical need for new treatments for advanced solid tumors that have become resistant to existing therapies, potentially offering a new option for patients with limited alternat This research targets Colorectal Neoplasms, Carcinoma, Non-Small-Cell Lung, Squamous Cell Carcinoma of the Head and Neck, Pancreatic Ductal Adenocarcinoma, where improved treatment options are needed.

Investor Insight

This Phase 1 trial, sponsored by Seagen (a Pfizer subsidiary), is an early-stage investigation into a novel drug for advanced cancers, indicating a significant investment in exploring new therapeutic Phase 1 trials have approximately a 10% chance of eventually gaining FDA approval.

Is This Trial Right for Me?

Ask your doctor about the study drug, potential side effects, and what to expect during the trial. Participation involves regular IV infusions of the study drug and frequent medical assessments, including blood tests and imaging. Be prepared to provide tumor tissue samples and potentially undergo biopsies for research purposes. The trial is being conducted at 20 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

Interventions

Primary Outcomes

Secondary Outcomes

Full Eligibility Criteria

Inclusion Criteria:

* Tumor types:

  * For Part A: Participants must have disease that is relapsed, refractory, or be intolerant to standard of care therapies, and in the judgement of the investigator must have no appropriate standard therapy available at the time of enrollment. Participants must have histologically- or cytologically confirmed metastatic or unresectable solid malignancy from one of the following tumor types:

    * Colorectal cancer (CRC)
    * Non-small cell lung cancer (NSCLC)
    * Head and neck squamous cell cancer (HNSCC)-non-nasopharyngeal subtype ONLY; nasopharyngeal subtype is not eligible.
  * For Part B: Participants must have disease that is relapsed, refractory, or be intolerant to standard of care therapies, and in the judgement of the investigator must have no appropriate standard therapy available at the time of enrollment.

    * The tumor type(s) to be enrolled in dose optimization will be identified by the sponsor from among those specified in Part A.
  * For Part C: Participants must have disease that is relapsed or refractory or be intolerant to standard of care therapies as specified below, unless contraindicated:

    * CRC

      * Participants must have unresectable locally advanced or metastatic CRC.
      * Prior therapy: Participants must have received prior fluoropyrimidine, oxaliplatin and irinotecan. Participants with defective mismatch repair and microsatellite instability high (dMMR/MSI-H) should have received prior treatment with pembrolizumab, a nivolumab-containing regimen, or other available anti-PD-1 (programmed cell death protein 1) or anti PD L1 (programmed cell death 1 ligand) agents.
    * NSCLC

      * Participants must have unresectable locally advanced or metastatic NSCLC.
      * Prior therapy: Participants must have received platinum-based therapy and at least 1 PD-1/PD-L1 inhibitor. These agents may have been administered either as single agents or in combination. Participants with an activating mutation or rearrangement (eg, EGFR, anaplastic lymphoma kinase \[ALK\], etc.) must have received available targeted agents if eligible by biomarker status and local standard of care.
    * HNSCC

      * Participants must have unresectable locally advanced or metastatic HNSCC - non-nasopharyngeal subtype ONLY; nasopharyngeal subtype is not eligible.
      * Prior therapy: Participants must have received platinum-based therapy and a PD-1/PD-L1 inhibitor, if eligible by biomarker status and local standard of care. These agents may have been administered either as single agents or in combination.
    * Pancreatic ductal adenocarcinoma (PDAC)

      * Participants must have unresectable locally advanced or metastatic PDAC.
      * Prior therapy: Participants must have received gemcitabine- or FOLFIRINOX-based therapy.
* Participants should provide archival tumor tissue if available and also agree to biopsies, if medically feasible
* An Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1.
* Measurable disease at baseline per RECIST 1.1 criteria.

Exclusion Criteria:

* History of another malignancy within 3 years before the first dose of study treatment, or any evidence of residual disease from a previously diagnosed malignancy. Exceptions are malignancies with a negligible risk of metastasis or death
* Known active central nervous system metastases or leptomeningeal disease. Participants with previously treated brain metastases may participate provided they are

  * clinically stable for at least 4 weeks prior to study entry after brain metastases treatment,
  * they have no new or enlarging brain metastases,
  * and are off of corticosteroids prescribed for symptoms associated with brain metastases for at least 7 days prior to the first dose of study drug.
* Treatment with an aminobisphosphonate IV (eg ibandronate, pamidronate, zoledronate, etc.) within 4 weeks of the first dose of study treatment.
* Participants with history of thromboembolic phenomena within 6 months prior to the first dose of study intervention, or with contraindication to thromboembolism prophylaxis (if clinically indicated) for a previous history of thrombus.

Trial Locations

Frequently Asked Questions

What is clinical trial NCT05983133?

NCT05983133 is a Phase 1 INTERVENTIONAL study titled "A Study of PF-08046052/SGN-EGFRd2 in Advanced Solid Tumors." It is currently active, not recruiting and is sponsored by Seagen, a wholly owned subsidiary of Pfizer. The trial targets enrollment of 68 participants.

What conditions does NCT05983133 study?

This trial investigates treatments for Colorectal Neoplasms, Carcinoma, Non-Small-Cell Lung, Squamous Cell Carcinoma of the Head and Neck, Pancreatic Ductal Adenocarcinoma. The primary condition under study is Colorectal Neoplasms.

What treatments are being tested in NCT05983133?

The interventions being studied include: PF-08046052 (DRUG). Given into the vein (IV; intravenously)

What does Phase 1 mean for NCT05983133?

Phase 1 trials are the first stage of testing a new treatment in humans. They focus on safety, dosage, and side effects, usually involving 20-100 healthy volunteers or patients.

What is the current status of NCT05983133?

This trial is currently "Active, Not Recruiting." It started on 2023-11-14. The estimated completion date is 2026-08-14.

Who is sponsoring NCT05983133?

NCT05983133 is sponsored by Seagen, a wholly owned subsidiary of Pfizer. The sponsor is responsible for funding, designing, and overseeing the clinical trial.

How many people can participate in NCT05983133?

The trial aims to enroll 68 participants. The trial status is active, not recruiting.

How is NCT05983133 designed?

This is a interventional study, uses na allocation, follows a sequential design, employs none masking.

What are the primary outcomes being measured in NCT05983133?

The primary outcome measures are: Number of participants with adverse events (AEs) (Through 90 days after last study treatment, up to approximately 1 year); Number of participants with laboratory abnormalities (Through 30-37 days after last study treatment, up to approximately 1 year); Number of participants with dose limiting toxicities (DLTs) (Up to 35 days); Number of participants with DLTs by dose level (Up to 35 days). These are the main endpoints researchers use to determine whether the treatment is effective.

Where is NCT05983133 being conducted?

This trial is being conducted at 20 sites, including Los Angeles, California; Santa Monica, California; Tampa, Florida; Iowa City, Iowa and 16 more sites (United States).

Where can I find official information about NCT05983133?

The official record for NCT05983133 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT05983133. This government database provides the most up-to-date and detailed information about the trial.

What is NCT05983133 testing in simple terms?

This study is testing the safety and side effects of a new drug called PF-08046052/SGN-EGFRd2. It is for adults with advanced solid tumors, including colorectal, lung, head and neck, and pancreatic cancers, that have not responded to standard treatments.

Why is this trial significant?

This trial addresses a critical need for new treatments for advanced solid tumors that have become resistant to existing therapies, potentially offering a new option for patients with limited alternat

What are the potential risks of participating in NCT05983133?

Common risks include side effects like nausea, fatigue, and changes in blood counts, which are closely monitored. More serious risks may include severe allergic reactions, organ damage, or blood clots, though these are less common. The study will carefully track any adverse events to ensure patient safety and determine the drug's tolerability. As with any clinical trial, participants are closely monitored and can withdraw at any time.

Should I consider participating in NCT05983133?

Ask your doctor about the study drug, potential side effects, and what to expect during the trial. Participation involves regular IV infusions of the study drug and frequent medical assessments, including blood tests and imaging. Be prepared to provide tumor tissue samples and potentially undergo biopsies for research purposes. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.

What does NCT05983133 signal from an investment perspective?

This Phase 1 trial, sponsored by Seagen (a Pfizer subsidiary), is an early-stage investigation into a novel drug for advanced cancers, indicating a significant investment in exploring new therapeutic This is a Phase 1 trial, which is in early development stages.

What happens if the treatment in this trial doesn't work?

Participants will receive the study drug intravenously (by IV) in cycles, and will undergo regular check-ups and tests. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.

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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.