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
- sigvotatug vedotin (drug), pembrolizumab (drug), cisplatin (drug), carboplatin (drug)
- How long the study runs
- Study runs about 105 months (dates as stated)
- About the drug or intervention
- sigvotatug vedotin — drug: Administered into the vein (IV; intravenously) · pembrolizumab — drug: 200mg every 3 weeks or 400mg every 6 weeks, given by IV · cisplatin — drug: 75 mg/m2 every 3 weeks, given by IV · carboplatin — drug: AUC 5 mg/mL per min every 3 weeks, given by IV
- Patient visit burden
- Not specified by the sponsor
In plain English
This study is testing a drug called sigvotatug vedotin in people with advanced solid tumours (cancers), including lung, head and neck, breast, gullet (oesophagus), pancreas, bladder, cervix, stomach and ovary cancers. It looks at how the drug works on its own or with other treatments, depending on the part of the study. The study is funded by Seagen, a company owned by Pfizer.
Who can take part
- You have an advanced or spread solid cancer of one of the types listed in the study
- For Parts A and B: your cancer has come back or not responded to standard treatment, or standard treatment was not suitable for you. For Part B you must also have had platinum chemotherapy and a PD-1 or PD-(L)1 immunotherapy drug, if these were available and suitable for you
- For Part C and D: you must not have had systemic (whole-body) treatment for locally advanced or spread cancer before. For Part C pembrolizumab (an immunotherapy drug) combinations, you must be able to have pembrolizumab and, where used, cisplatin or carboplatin chemotherapy, as standard care allows
- For some parts of the study, you must agree to a tumour biopsy (a small sample of tissue taken), either a new one or one stored within the last 90 days
- You can carry out usual daily activities with little or no restriction (performance status score of 0 or 1)
- Your cancer can be measured on scans using standard guidelines (RECIST version 1.1)
Who may not be able to
- You have had another cancer in the last 3 years, unless it was a type with a very low risk of spreading or causing death, or there is no remaining disease
- You have active cancer spread to the brain. Treated brain metastases may be allowed if stable for at least 4 weeks, no new or growing spots, and off steroid tablets for at least 7 days before starting. In Part D, small untreated spots (under 1 cm) with no symptoms may be allowed
- You have cancer in the lining of the brain and spinal cord (carcinomatous meningitis)
- You have had a drug containing MMAE or a drug targeting integrin beta-6 before
- You already have numbness or tingling in the nerves (neuropathy) of a certain level — Grade 1 or worse for some Part C and D groups, Grade 2 or worse for all other groups
- You have an uncontrolled serious infection (Grade 3 or higher) within 2 weeks of starting the study drug, though regular infection-preventing medicines are allowed
- You have serious lung disease (Grade 3 or worse) not caused by your cancer
- For Parts C and D: you had immunotherapy before and had to stop because of a serious immune-related side effect (Grade 3 or higher)
- You have had lung inflammation (interstitial lung disease or pneumonitis) needing steroids, have it now, or it cannot be ruled out on scans
- Your lung breathing test (DLCO) result is less than 50% of what is expected
- You are study staff involved in running the trial, or a family member, or an employee of the sponsor directly involved in the study, or their family member
What taking part involves
- • Taking the study drug sigvotatug vedotin
- • In some parts of the study (Part C), taking it with pembrolizumab, an immunotherapy drug
- • In some groups, taking pembrolizumab together with cisplatin or carboplatin chemotherapy
- • For some parts, having tumour biopsies, including before treatment and during the first treatment cycle
Time commitment: Not stated — ask the trial team (details such as number of visits, how long the study lasts, and how the drug is given are not in the data above).
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
- 1,006
- Started
- 2020-06-08
- Last checked
- 2026-07
Plain English Summary
What is this study?
- • Testing a new treatment for carcinoma, non-small cell lung
- • Phase1 - 1,006 participants
- • This trial will look at a drug called sigvotatug vedotin (SGN-B6A) alone and with pembrolizumab, with or without chemotherapy, to find out whether it is safe for people who have solid tumors
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with carcinoma, non-small cell lung
Where?
- • Sutton - The Royal Marsden Hospital (Surrey)
- • Sutton - Royal Marsden Hospital
- • Birmingham - Queen Elizabeth Hospital
- • Birmingham - University Hospitals Birmingham NHS Foundation Trust
- • +5 more UK sites
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
This trial will look at a drug called sigvotatug vedotin (SGN-B6A) alone and with pembrolizumab, with or without chemotherapy, to find out whether it is safe for people who have solid tumors. It will study sigvotatug vedotin to find out what its side effects are. A side effect is anything the drug does besides treating cancer. It will also study whether sigvotatug vedotin works to treat solid tumors. The study will have four parts. * Part A of the study will find out how much sigvotatug vedotin should be given to participants. * Part B will use the dose found in Part A to find out how safe sigvotatug vedotin is and if it works to treat solid tumors. * Part C of the study will find out how safe sigvotatug vedotin is in combination with these other drugs. * Part D will include people who have not received treatment. This part of the study will find out how safe sigvotatug vedotin is in combination with these other drugs and if these combinations work to treat solid tumors. * In Parts C and D, participants will receive sigvotatug vedotin with either: * Pembrolizumab or, * Pembrolizumab and carboplatin, or * Pembrolizumab and cisplatin.
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:
- ✓ disease that is relapsed or refractory or be intolerant to standard-of-care therapies
- ✓ a PD-1 inhibit
What the study is looking for
- ✓Disease indication
- ✓Participants must have confirmed by testing a sample that has spread or unresectable solid cancer within...
- ✓Non-small cell lung cancer (NSCLC)
- ✓Head and neck squamous cell cancer (HNSCC)
- ✓Advanced HER2-negative breast cancer
See the full criteria
Where Is This Study? (9 UK sites)
The Royal Marsden Hospital (Surrey)
Sutton SM2 5PT, United Kingdom
Royal Marsden Hospital
Sutton SM2 5PT, United Kingdom
Queen Elizabeth Hospital
Birmingham B15 2TH, United Kingdom
University Hospitals Birmingham NHS Foundation Trust
Birmingham B15 2TH, United Kingdom
The Royal Marsden NHS Foundation Trust
London SW3 6JJ, United Kingdom
Sarah Cannon Research Institute
London W1G 6AD, United Kingdom
Diagnostic centre
London W1G 7AF, United Kingdom
The Harley Street Clinic
London W1G 8BJ, United Kingdom
Radiology
London W1G 8PP, United Kingdom
How to Get in Touch
Pfizer CT.gov Call Center
Sponsor contactCONTACT
