NCT04389632Recruiting
A Study of Sigvotatug Vedotin in Advanced Solid Tumors
Summary
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.
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.
Contacts
The trial team's contact details are shown on request.
See the official trial record- Status
- Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Countries
- Switzerland, France, United States, South Korea, Spain, Taiwan, United Kingdom
- Sponsor
- Seagen, a wholly owned subsidiary of Pfizer(Industry)
- Protocol no.
- SGNB6A-001
- Conditions
- Carcinoma, Non-Small Cell Lung, Squamous Cell Carcinoma of Head and Neck, HER2 Negative Breast Neoplasms, Esophageal Squamous Cell Carcinoma, Esophageal Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma, Ovarian Neoplasms, Cutaneous Squamous Cell Cancer, Exocrine Pancreatic Adenocarcinoma, Urinary Bladder Neoplasms, Uterine Cervical Neoplasms, Stomach Neoplasms
- Interventions
- Drug
Treatments studied
- sigvotatug vedotin
- pembrolizumab
- cisplatin
- carboplatin
Locations · 145
- Chur, SwitzerlandKantonsspital GraubundenRecruiting at this site
- Lausanne, SwitzerlandUniversity Hospital Lausanne CHUVRecruiting at this site
- Lausanne, SwitzerlandCHUV - Service de pharmacie BH-04, Essais cliniquesRecruiting at this site
- Nice, FranceCentre de Lutte contre le Cancer (CLCC) - Centre Antoine LacassagneRecruiting at this site
- Poitiers, FranceCentre Hospitalier Universitaire de PoitiersRecruiting at this site
- Vandœuvre-lès-Nancy, FranceInstitut de Cancérologie de LorraineRecruiting at this site
- Villejuif, FranceInstitut Gustave Roussy Department de Pharmacie Clinique(-1)Recruiting at this site
- Villejuif, Francelnstitut Gustave Roussy, Departement d'lnnovation Therapeutique et d'Essais Precoces (DITEP)Recruiting at this site
- Anchorage, United StatesAlaska Oncology and HematologyRecruiting at this site
- Fayetteville, United StatesHighlands Oncology GroupRecruiting at this site
- Rogers, United StatesHighlands Oncology GroupRecruiting at this site
- Springdale, United StatesHighlands Oncology GroupRecruiting at this site
- Anaheim, United StatesProvidence Medical FoundationRecruiting at this site
- Fullerton, United StatesProvidence Medical FoundationRecruiting at this site
- Fullerton, United StatesProvidence St. Jude Medical Center Virginia K Crosson and Infusion CenterRecruiting at this site
- Los Angeles, United StatesRonald Reagan UCLA Medical CenterRecruiting at this site
- Los Angeles, United StatesThe Regents of the University of CaliforniaRecruiting at this site
- Los Angeles, United StatesUCLA Department of Medicine-Hematology/OncologyRecruiting at this site
- Santa Monica, United StatesUCLA Department of Medicine - Hematology & OncologyRecruiting at this site
- Fort Myers, United StatesAmerican Oncology Partners, PA. a Florida professional service corporation, d/b/a Vista OncologyRecruiting at this site
- Fort Myers, United StatesFlorida Cancer Specialists & Research Institute, LLCRecruiting at this site
- Hollywood, United StatesMemorial Cancer InstituteRecruiting at this site
- Hollywood, United StatesMemorial Healthcare SystemRecruiting at this site
- Orlando, United StatesFlorida Cancer SpecialistsRecruiting at this site
- Pembroke Pines, United StatesMemorial Cancer Institute at Memorial Hospital WestRecruiting at this site
- Pembroke Pines, United StatesMemorial Hospital WestRecruiting at this site
- Calumet City, United StatesIngalls Family Care CenterRecruiting at this site
- Chicago, United StatesUChicago Medicine - River EastRecruiting at this site
- Chicago, United StatesThe University Of ChicagoRecruiting at this site
- Chicago, United StatesUniversity of Chicago Medical CenterRecruiting at this site
In total, worldwide, 145 of the 158 sites listed in the registry are recruiting; the other 13 are not currently recruiting.
Site status per the ClinicalTrials.gov registry (last update posted: July 6, 2026).
This status may have changed and says nothing about your eligibility: before taking any step, check with your oncologist or the site.
+ 115 more locations
Other identifiers
- C5751001 · other identifier
- 2023-508469-34-00 · other registry
- 2023 · NIH grant
See also
Other versions
These results are indicative and do not replace medical advice — discuss them with your doctor.