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Testing a new drug for advanced solid tumors

A Phase 1 Study of PF-08046054/SGN-PDL1V in Advanced Solid Tumors

Phase 1 Interventional Seagen Inc. · NCT05208762

This study is testing a new drug for people with advanced solid tumors, like lung and head and neck cancers, to see if it works better when combined with another treatment after other options have failed.

Quick facts

PhasePhase 1
Study typeInterventional
Enrollment714 (estimated)
Ages18 Years and up
SexAll
SponsorSeagen Inc. Industry-sponsored
Drugs / interventionspembrolizumab
Locations61 sites (Birmingham, Alabama and 60 other locations)
Trial IDNCT05208762 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include individuals with metastatic or unresectable solid tumors such as non-small cell lung cancer or head and neck squamous cell carcinoma who have exhausted standard treatment options.

Not a fit: Patients with nasopharyngeal cancer or those who have not progressed on standard therapies 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 that are difficult to treat.

How similar studies have performed: Other studies have shown promise with similar immunotherapy approaches, suggesting potential for success in this novel combination.

Eligibility criteria

Show full inclusion / exclusion criteria 
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 this trial is running

Birmingham, Alabama and 60 other locations

+11 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Carcinoma, Non-Small-Cell LungSquamous Cell Carcinoma of the Head and NeckEsophageal Squamous Cell CarcinomaTriple Negative Breast NeoplasmsGastric CancerEndometrial CancerPancreatic AdenocarcinomaHepatocellular Carcinoma
Last reviewed 2026-06-09 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.