A Phase 1 Study of Sigvotatug Vedotin in Advanced Solid Tumors
Seagen, a wholly owned subsidiary of Pfizer
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 ca…
Interventions
- Drugsigvotatug vedotin
Administered into the vein (IV; intravenously)
- Drugpembrolizumab
200mg every 3 weeks or 400mg every 6 weeks, given by IV
- Drugcisplatin
75 mg/m2 every 3 weeks, given by IV
- Drugcarboplatin
AUC 5 mg/mL per min every 3 weeks, given by IV
Locations (158)
- Alaska Oncology and HematologyAnchorage, Alaska
- Highlands Oncology GroupFayetteville, Arkansas
- Highlands Oncology GroupRogers, Arkansas
- Highlands Oncology GroupSpringdale, Arkansas
- Providence Medical FoundationAnaheim, California
- Providence Medical FoundationFullerton, California