Full Title
A Phase 1 Study of SGN-B6A in Advanced Solid Tumors
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.
Study Treatment
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.
Sigvotatug vedotin monotherapy
Part C of the study will find out how safe sigvotatug vedotin is in combination with these other drugs.
Combination therapy in NSCLC, HNSCC, ESCC
Sigvotatug vedotin + pembrolizumab (Keytruda) +/- (carboplatin or cisplatin)
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.
Combination therapy in 1L NSCLC
Sigvotatug vedotin + pembrolizumab (Keytruda) +/- (carboplatin)
or
Combination therapy in 1L HNSCC
Sigvotatug vedotin + pembrolizumab (Keytruda) +/- (carboplatin or cisplatin)
Eligibility/Info
• 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)
• Participants should have a tumor site accessible for biopsy or archival biopsy collected within 90 days prior to first dose of study drug may be used.
• 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.
Contact
For more information you may contact the Research Department through the NYCBS HALO Messaging Center or call directly: 631-675-5075.
