NCT04389632

A Study of Sigvotatug Vedotin in Advanced Solid Tumors

A Phase 1 Study of Sigvotatug Vedotin in Advanced Solid Tumors

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 1,006 (estimated)
• Sponsor: Seagen, a wholly owned subsidiary of Pfizer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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

Type	Name	Description
DRUG	sigvotatug vedotin	Administered into the vein (IV; intravenously)
DRUG	pembrolizumab	200mg every 3 weeks or 400mg every 6 weeks, given by IV
DRUG	cisplatin	75 mg/m2 every 3 weeks, given by IV
DRUG	carboplatin	AUC 5 mg/mL per min every 3 weeks, given by IV

Timeline

• Start date: 2020-06-08
• Primary completion: 2027-06-16
• Completion: 2029-03-22
• First posted: 2020-05-15
• Last updated: 2026-04-07

Locations

155 sites across 7 countries: United States, France, South Korea, Spain, Switzerland, Taiwan, United Kingdom

Regulatory

• FDA-regulated drug study