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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
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
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
Where Is This Study? (7 UK sites)
Diagnostic Centre
London W1G 7AF, United Kingdom
The Harley Street Clinic (THSC)
London W1G 8BJ, United Kingdom
Pharmacy: Royal Marsden Hospital
Sutton SM2 5PT, United Kingdom
Royal Marsden Hospital
Sutton SM2 5PT, United Kingdom
The Royal Marsden NHS Foundation Trust
London SW3 6JJ, United Kingdom
Sarah Cannon Research Institute
London W1G 6AD, United Kingdom
Radiology
London W1G 8PP, United Kingdom
How to Get in Touch
Seagen Pfizer CT.gov Call Center
Sponsor contactCONTACT
