RecruitingCarcinoma, Non-Small Cell LungSquamous Cell Carcinoma of Head and NeckHER2 Negative Breast Neoplasms

A Study of Sigvotatug Vedotin in Advanced Solid Tumors

Eligible age

18+ yrs

Accepts

All genders

Locations

19 states

Healthy volunteers

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About this study

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.

Sponsor: Seagen, a wholly owned subsidiary of Pfizer

You may qualify if…

✓ 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)

You may not qualify if…

✕ 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