A Study of PF-08046054/SGN-PDL1V in Advanced Solid Tumors
Eligible age
18+ yrs
Accepts
All genders
Locations
8 states
Healthy volunteers
No
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About this study
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.
Sponsor: Seagen, a wholly owned subsidiary of Pfizer
You may qualify if…
- ✓ 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
You may not qualify if…
- ✕ 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.
Where it's recruiting
Source: ClinicalTrials.gov · NCT05208762 · last updated 2026-04-20