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Looking for participantsPhase1

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

Sponsor: Seagen, a wholly owned subsidiary of Pfizer

NCT ID: NCT05208762

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
PF-08046054 (drug), pembrolizumab (drug)
How long the study runs
Study runs about 75 months (dates as stated)
About the drug or intervention
PF-08046054 — drug: Given into the vein (IV; intravenously) · pembrolizumab — drug: 200 mg once every 3 weeks given into the vein (IV; intravenously)
Patient visit burden
Not specified by the sponsor

In plain English

This study is testing a new drug called PF-08046054/SGN-PDL1V in people with advanced solid tumours, including lung cancer, head and neck cancer, food pipe (oesophageal) cancer, an aggressive type of breast cancer, stomach cancer, womb (endometrial) cancer, pancreatic cancer and liver cancer. It is run by Seagen, a wholly owned subsidiary of Pfizer. What the study involves and its results are not stated — ask the trial team.

Who can take part

  • People with one of the listed advanced solid tumours that has come back, not responded to treatment, or standard treatment is not suitable, not tolerated or refused
  • The cancer must be confirmed by tissue or cell testing
  • Testing must show the cancer has PD-L1 expression (for some parts of the study, a certain level is needed)
  • Being well enough to look after yourself — an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
  • Having measurable disease on scans per RECIST v1.1 at the start

Who may not be able to

  • Another cancer within the last 3 years, or any remaining disease from a previous cancer
  • Active cancer spread to the brain (unless previously treated, stable for at least 4 weeks, no new or growing spread, and off steroid medicine for at least 7 days)
  • Leptomeningeal disease (cancer in the tissues around the brain and spinal cord)
  • Treatment with a PD-L1-blocking drug within less than 5 half-lives of that drug
  • Previous treatment with a drug containing monomethyl auristatin E (MMAE)
  • Existing nerve damage (neuropathy) of Grade 2 or worse

What taking part involves

  • • Receiving the study drug PF-08046054/SGN-PDL1V — details of how it is given are not stated — ask the trial team

Time commitment: Visits, duration and what taking part involves are not stated — ask the trial team.

Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.

Type of study
Testing a treatment
Ages
18 Years and over
Who
All
Number of participants
714
Started
2022-10-25
Last checked
2026-07

Plain English Summary

What is this study?

  • • Testing a new treatment for carcinoma, non-small-cell lung
  • • Phase1 - 714 participants
  • • This study will test the safety of a drug called PF-08046054/SGN-PDL1V alone and with pembrolizumab in participants with solid tumors

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with carcinoma, non-small-cell lung

Where?

  • • London - Diagnostic Centre
  • • London - The Harley Street Clinic (THSC)
  • • Sutton - Pharmacy: Royal Marsden Hospital
  • • Sutton - Royal Marsden Hospital
  • • +3 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

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.

Carcinoma, Non-Small-Cell LungSquamous Cell Carcinoma of the Head and NeckEsophageal Squamous Cell CarcinomaTriple Negative Breast NeoplasmsGastric CancerEndometrial CancerPancreatic AdenocarcinomaHepatocellular Carcinoma

How this trial compares with your answers

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What we know so far

Condition· Matched your search
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Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders

Biomarkers mentioned

Triple negativePD-L1PD-L1 expression ≥1PD-L1 expression ≥ 1%met

Treatment history

Treatments you must have had:

  • ✓ PD-L1 expression based on historical testing
  • ✓ histologically or cytologically-confirmed HNSCC
  • ✓ histologically or cytologically-confirmed NSCLC
  • ✓ histologically or cytologically-confirmed disease of the HNSCC or NSCLC

What the study is looking for

  • ✓Parts A and B:
  • ✓Participants must have one of the following histologically- or cytologically-confirmed that has spread or unresectable...
  • ✓Non-small cell lung cancer (NSCLC)
  • ✓Head and neck squamous cell carcinoma (HNSCC) (except nasopharyngeal cancer)
  • ✓Esophageal squamous cell carcinoma (SCC)

Who cannot take part

  • ✗History of another cancer within 3 years of first dose of study treatment or any evidence of residual disease...
  • ✗Known active central nervous system metastases. Participants with previously-treated brain metastases may...
  • ✗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...
See the full 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 Is This Study? (7 UK sites)

Diagnostic Centre

London W1G 7AF, United Kingdom

Recruiting

The Harley Street Clinic (THSC)

London W1G 8BJ, United Kingdom

Recruiting

Pharmacy: Royal Marsden Hospital

Sutton SM2 5PT, United Kingdom

Recruiting
Hospital R&D contact (matched)

Mark Brandon-Grove

research.development@rmh.nhs.uk020 3186 5416

Royal Marsden Hospital

Sutton SM2 5PT, United Kingdom

Recruiting
Hospital R&D contact (matched)

Mark Brandon-Grove

research.development@rmh.nhs.uk020 3186 5416

The Royal Marsden NHS Foundation Trust

London SW3 6JJ, United Kingdom

Recruiting
Hospital R&D contact (matched)

Mark Brandon-Grove

research.development@rmh.nhs.uk020 3186 5416

Sarah Cannon Research Institute

London W1G 6AD, United Kingdom

Recruiting

Radiology

London W1G 8PP, United Kingdom

Recruiting

How to Get in Touch

Seagen Pfizer CT.gov Call Center

Sponsor contact

CONTACT

1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-07