Testing a new drug for advanced solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the safety and efficacy of a drug called PF-08046054/SGN-PDL1V, both alone and in combination with pembrolizumab, in patients with advanced solid tumors that are metastatic or unresectable. The trial is divided into five parts, with the initial parts determining the appropriate dosage of the drug, followed by assessments of its safety and effectiveness. Participants will have specific types of cancer, including non-small cell lung cancer and head and neck squamous cell carcinoma, and must have previously failed standard treatments. The study aims to gather data on side effects and therapeutic outcomes.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Parts A and B:

  * Participants must have one of the following histologically- or cytologically-confirmed metastatic or unresectable solid tumor types

    * Non-small cell lung cancer (NSCLC)
    * Head and neck squamous cell carcinoma (HNSCC) (except nasopharyngeal cancer)
    * Esophageal squamous cell carcinoma (SCC)
    * Triple negative breast cancer (TNBC)
  * Participants must have disease that is relapsed or refractory, that has progressed on approved therapies, be intolerant to or refused such therapies, or such and therapies are contraindicated and in the judgement of the investigator, should have no appropriate SoC therapeutic option
  * Participants must have PD-L1 expression based on historical testing
* Part C:

  * Participants must have disease that is relapsed or refractory or be intolerant to SoC therapies and must have one of the following tumor types

    * HNSCC

      * Participants with HNSCC must have histologically or cytologically-confirmed HNSCC
    * NSCLC

      * Participants must have histologically or cytologically-confirmed NSCLC. Participants with SCC and non--SCC histology are eligible. Note: Participants with a neuroendocrine component or histology are not eligible.
    * Esophageal SCC
    * Pancreatic cancer
    * Hepatocellular carcinoma
    * TNBC
    * Gastric cancer
    * Endometrial cancer
  * Participants must have been previously tested for PD-L1 expression and should have PD-L1 expression ≥1 or \<1 by CPS or TPS based on historical testing
* Part D and Part E:

  * Participants must have histologically or cytologically-confirmed disease of the HNSCC or NSCLC
  * Participants must have PD-L1 expression based on historical testing
  * Participants with NSCLC; PD-L1 expression ≥ 1% by TPS
  * Participants with HNSCC; PD--L1 expression ≥1 by CPS
* Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
* Measurable disease per RECIST v1.1 at baseline

Exclusion Criteria:

* History of another malignancy within 3 years of first dose of study treatment or any evidence of residual disease from a previously diagnosed malignancy.
* Known active central nervous system metastases. Participants with previously-treated brain metastases may participate provided they:

  * Are clinically stable for at least 4 weeks prior to study entry after brain metastasis treatment
  * Have no new or enlarging brain metastases
  * And are off of corticosteroids prescribed for symptoms associate with brain metastases for at least 7 days prior to first dose of study treatment
* Lepto-meningeal disease
* Prior treatment with an anti-PD-L1 agent within less than 5 half-lives. This duration of time will vary according to the half-life of the specific agent.
* Previous receipt of an monomethylauristatin E (MMAE)-containing agent.
* Pre-existing neuropathy ≥Grade 2 per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.

There are additional inclusion criteria. The study center will determine if criteria for participations are met.

Where it's running

• University of Alabama at Birmingham
  Birmingham, Alabama, United States Recruiting
• University of Alabama at Birmingham, IDS Pharmacy
  Birmingham, Alabama, United States Recruiting
• University of Alabama at Birmingham
  Birmingham, Alabama, United States Recruiting
• University of Alabama at Birmingham
  Birmingham, Alabama, United States Recruiting
• Chao Family Comprehensive Cancer Center and Ambulatory Care
  Irvine, California, United States Recruiting
• UC Irvine Health - Chao Family Comprehensive Cancer Center
  Orange, California, United States Recruiting

+12 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Seagen Pfizer CT.gov Call Center
• Email: ClinicalTrials.gov_Inquiries@pfizer.com
• Phone: 1-800-718-1021

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.