Testing a new drug for advanced solid tumors

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

This study is testing a new drug for people with advanced solid tumors that can't be removed or have spread, to see if it is safe and works better than current treatments.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 290 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Seagen Inc. (industry)
• Drugs / interventions: pembrolizumab, nivolumab
• Locations: 13 sites (Santa Monica, California and 12 other locations)
• Trial ID: NCT05983133 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and side effects of a drug called PF-08046052/SGN-EGFRd2 in patients with advanced solid tumors that are either unresectable or metastatic. The trial is divided into three parts: the first two parts will determine the appropriate dosage of the drug, while the third part will assess its safety and effectiveness in treating specific types of cancer. Participants must have tumors that have not responded to standard therapies and have no other treatment options available.

Who should consider this trial

Good fit: Ideal candidates include individuals with relapsed, refractory, or intolerant advanced colorectal cancer, non-small cell lung cancer, or head and neck squamous cell carcinoma.

Not a fit: Patients with nasopharyngeal subtype head and neck squamous cell carcinoma or those who have not exhausted standard treatment options may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new treatment option for patients with advanced solid tumors who have exhausted other therapies.

How similar studies have performed: Other studies have shown promise in targeting similar advanced solid tumors with novel therapies, indicating potential for success in this approach.

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.

Where this trial is running

Santa Monica, California and 12 other locations

• UCLA Department of Medicine - Hematology & Oncology — Santa Monica, California, United States (RECRUITING)
• Moffitt Cancer Center McKinley Hospital — Tampa, Florida, United States (RECRUITING)
• University of Iowa — Iowa City, Iowa, United States (RECRUITING)
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States (RECRUITING)
• Karmanos Cancer Institute — Detroit, Michigan, United States (RECRUITING)
• John Theurer Cancer Center at Hackensack University Medical Center — Hackensack, New Jersey, United States (RECRUITING)
• Wake Forest Baptist Medical Center / Wake Forest University — Winston-Salem, North Carolina, United States (RECRUITING)
• University Hospitals Cleveland Medical Center — Cleveland, Ohio, United States (RECRUITING)
• Providence Cancer Institute Franz Clinic — Portland, Oregon, United States (RECRUITING)
• MD Anderson Cancer Center - University of Texas — Houston, Texas, United States (RECRUITING)
• Huntsman Cancer Institute, University Of Utah — Salt Lake City, Utah, United States (RECRUITING)
• University College London Hospital, NIHR UCLH Clinical Research Facility — London, United Kingdom (RECRUITING)
• The Christie NHS Foundation Trust — Manchester, United Kingdom (RECRUITING)

Study contacts

• Study coordinator: Pfizer CT.gov Call Center

Conditions: Colorectal Neoplasms, Carcinoma, Non-Small-Cell Lung, Squamous Cell Carcinoma of the Head and Neck, Pancreatic Ductal Adenocarcinoma, CRC, Colon Cancer, Rectal Cancer, NSCLC