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Looking for participantsPhase1

A Study of Sigvotatug Vedotin in Advanced Solid Tumors

Sponsor: Seagen, a wholly owned subsidiary of Pfizer

NCT ID: NCT04389632

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
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.

Carcinoma, Non-Small Cell LungSquamous Cell Carcinoma of Head and NeckHER2 Negative Breast NeoplasmsEsophageal Squamous Cell CarcinomaEsophageal AdenocarcinomaGastroesophageal Junction AdenocarcinomaOvarian NeoplasmsCutaneous Squamous Cell CancerExocrine Pancreatic AdenocarcinomaUrinary Bladder NeoplasmsUterine Cervical NeoplasmsStomach Neoplasms

How this trial compares with your answers

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What we know so far

Condition· Matched your search
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Still need:

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  • • 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

HER2

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
Inclusion Criteria: * Disease indication * Participants must have histologically or cytologically confirmed metastatic or unresectable solid malignancy within one of the tumor types listed below (dependent on study part). * Non-small cell lung cancer (NSCLC) * Head and neck squamous cell cancer (HNSCC) * Advanced HER2-negative breast cancer * Esophageal squamous cell carcinoma (ESCC) * Esophageal/Gastro-esophageal junction adenocarcinoma (EAC/GEJ) * Cutaneous squamous cell cancer (cSCC) * Exocrine pancreatic adenocarcinoma * Bladder cancer * Cervical cancer * Gastric cancer * High grade serous ovarian cancer (HGSOC) * Part A only: Participants must have disease that is relapsed or refractory or be intolerant to standard-of-care therapies and should have no appropriate standard-of-care therapeutic options. * Part B only: Participants must have disease that is relapsed or refractory or be intolerant to standard-of-care therapies. Participants must have received platinum-based therapy and a PD-1/PD-(L)1 inhibitor, if applicable and available. * Part C only: For pembrolizumab combination cohorts, participants must be eligible for pembrolizumab per local standard of care. For pembrolizumab with cisplatin or carboplatin, participants must be eligible for both pembrolizumab and the platinum agent per local standard of care. Participants must be treatment naïve for locally advanced or metastatic systemic therapy (prior definitively intended or \[neo\]adjuvant therapy is allowed). * Part D only: Participants must be treatment naïve for locally advanced or metastatic systemic therapy. * Participants enrolled in the following study parts should have a tumor site accessible for biopsy and agree to biopsy as follows: * Disease-specific expansion cohorts (Part B and Part D): A baseline fresh tumor biopsy is required. An archival biopsy collected within 90 days prior to first dose of study drug may be used. * Biology expansion cohort: pretreatment biopsy and on-treatment (Cycle 1) biopsy * An Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 * Measurable disease per the RECIST v1.1 at baseline Exclusion Criteria * History of another malignancy within 3 years before first dose of study drug, or any evidence of residual disease from a previously diagnosed malignancy. Exceptions are malignancies with a negligible risk of metastasis or death. * 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 associated with brain metastases for at least 7 days prior to first dose of study drug. * In Part D, participants with untreated, asymptomatic CNS metastases smaller than 1 cm may be enrolled without definitive treatment as long as they have no neurological symptoms, no or minimal surrounding edema, and no requirements for corticosteroids. * Carcinomatous meningitis * Previous receipt of an MMAE-containing agent or an agent targeting integrin beta-6 * Pre-existing neuropathy Grade 1 or greater per the National Cancer Institute's Common Terminology Criteria for Adverse Events, version 5.0 (NCI CTCAE v5.0) for Parts C and D cohorts with cisplatin or carboplatin; Grade 2 or greater per the NCI CTCAE v5.0 for all other cohorts * Any uncontrolled Grade 3 or higher (per NCI CTCAE v5.0) viral, bacterial, or fungal infection within 2 weeks prior to the first dose of sigvotatug vedotin. * Routine antimicrobial prophylaxis is permitted * Grade ≥3 pulmonary disease unrelated to underlying malignancy. This includes clinically severe pulmonary function compromise resulting from clinically significant pulmonary illnesses * Part C and D: Prior therapy with a PD-1 inhibitor, anti-PD-(L)1, or anti PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor and was discontinued from that treatment due to a Grade 3 or higher immune-mediated adverse event (IMAE). * History of noninfectious interstitial lung disease (ILD) or pneumonitis that required steroids, current ILD or pneumonitis, or suspected ILD or pneumonitis that cannot be ruled out by imaging at screening * Known diffusing capacity of the lung for carbon monoxide (DLCO; adjusted for hemoglobin) \<50% predicted * Investigator site staff directly involved in the conduct of the study and their family members, site staff otherwise supervised by the investigator, and sponsor and sponsor delegate employees directly involved in the conduct of the study and their family members.

Where Is This Study? (9 UK sites)

The Royal Marsden Hospital (Surrey)

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

Queen Elizabeth Hospital

Birmingham B15 2TH, United Kingdom

Recruiting
Hospital R&D contact (matched)

Tom Dymond

research&development@qehkl.nhs.uk01553 613532

University Hospitals Birmingham NHS Foundation Trust

Birmingham B15 2TH, United Kingdom

Recruiting
Hospital R&D contact (matched)

Sarah Pountain Head of Research Governance

R&D@uhb.nhs.uk0121 371 4185

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

Diagnostic centre

London W1G 7AF, United Kingdom

Recruiting

The Harley Street Clinic

London W1G 8BJ, United Kingdom

Recruiting

Radiology

London W1G 8PP, United Kingdom

Recruiting

How to Get in Touch

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