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

Official record

Identifier

NCT05208762

Recruiting locations

countries

United StatesBelgiumCanadaChinaFranceGermanyItalyJapanNetherlandsSpainUnited Kingdom

Interventions studied

PF-08046054pembrolizumab

Lead sponsor

Seagen, a wholly owned subsidiary of Pfizer

Target enrolment

714 participants

Study type

INTERVENTIONAL

Phase

Phase 1

Status

Recruiting

First posted

Jan 26, 2022

Last updated on the registry

Jul 22, 2026

Age

18 Years

Sex

ALL

Study contact

The official record lists a study contact. Contact details are published there and are intentionally not copied to this page.

Eligibility criteria

Reproduced verbatim from the official record. Eligibility is decided by the study team, never by this page.

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.

Indexed under

Esophageal Cancer