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

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorSeagen, a wholly owned subsidiary of Pfizer

About this trial

This study will test the safety of a drug called PF-08046054/SGN-PDL1V alone and with pembrolizumab in participants with solid tumors. It will also study the side effects of this drug. A side effect is anything a drug does to your body besides treating your disease.

Participants will have solid tumor cancer that has spread through the body (metastatic) or cannot be removed with surgery (unresectable).

This study will have five parts. Parts A and B of the study will find out how much PF-08046054/SGN- PDL1V should be given to participants. Part C will use the dose found in Parts A and B to find out how safe PF-08046054/SGN-PDL1V is and if it works to treat solid tumor cancers. In Part D and E, participants will be given PF-08046054/SGN-PDL1V with pembrolizumab to find out how safe this combination is and if it works to treat solid tumor cancers.

Eligibility criteria

Qualifiers

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)

Disqualifiers

History of another malignancy within 3 years of first dose of study treatment or any evidence of residual disease from a previously diagnosed malignancy.

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

Trial design

Treatments tested in this trial

  • PF-08046054
  • pembrolizumab

Treatment groups

714 Participants
are divided into 2 treatment groups