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Study of PF-08046054/SGN-PDL1V for Advanced Solid Tumors

This study is testing a drug called PF-08046054/SGN-PDL1V, both alone and in combination with pembrolizumab, for people with advanced solid tumors. These are cancers that have spread or cannot be removed by surgery, including certain types of lung, head and neck, esophageal, breast (triple negative), and gastric cancers. The main goals are to understand the safety and side effects of PF-08046054/SGN-PDL1V, and to find the right dose. Later parts of the study will also see if the drug helps treat these cancers. This study is looking for 714 participants and is currently unclear on its recruitment status.

Study design
This study is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 714 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Your health will be monitored for adverse events (side effects) and laboratory changes for up to 3 years after your last study treatment. Dose-limiting toxicities will be monitored for about 1 month during the first cycle of treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05208762

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
Seagen, a wholly owned subsidiary of Pfizer
~714 participants
Updated 2026-07-22 on ClinicalTrials.gov
What's tested:PF-08046054pembrolizumab

At a glance

Recruiting sites
62 of 62 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of participants with adverse events (AEs)
Measured over Through approximately 90 days after last study treatment; up to 3 years
+3 more outcomes measured

Conditions

Carcinoma, Non-Small-Cell Lung
Squamous Cell Carcinoma of the Head and Neck
Esophageal Squamous Cell Carcinoma
Triple Negative Breast Neoplasms
Gastric Cancer
Endometrial Cancer
Pancreatic Adenocarcinoma
Hepatocellular Carcinoma

Explore related trials

Endometrial CarcinomaEsophageal Squamous Cell CarcinomaGastric CarcinomaHead and Neck Squamous Cell CarcinomaHepatocellular CarcinomaLung Non-Small Cell CarcinomaPancreatic CarcinomaSolid NeoplasmTriple-negative breast cancer

Where it's being run

62 sites across 27 states
Texas11
France6
Alabama4
California4
Other4
Spain4
Germany3
United Kingdom3

Study leadership

  • Pfizer CT.gov Call Center · STUDY_DIRECTOR · Pfizer

Who to contact

Seagen Pfizer CT.gov Call Center
[email protected]
1-800-718-1021
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Number of participants with adverse events (AEs)Through approximately 90 days after last study treatment; up to 3 years

    Any untoward medical occurrence in a clinical investigational participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment.

  • Number of participants with laboratory abnormalitiesThrough approximately 90 days after last study treatment; up to 3 years
  • Number of participants with dose-limiting toxicities (DLTs)Through the first cycle of study treatment; approximately 1 month
  • Number of participants with DLTs by dose levelThrough the first cycle of study treatment; approximately 1 month