A Study of Sigvotatug Vedotin in Advanced Solid Tumors
Part of paid clinical trials in Anchorage, Alaska.
- Sponsor
- Seagen, a wholly owned subsidiary of Pfizer
- Study ID
- NCT04389632
- Phase
- PHASE1
- Status
- Recruiting
Conditions
- Carcinoma, Non-Small Cell Lung
- Cutaneous Squamous Cell Cancer
- Esophageal Adenocarcinoma
- Esophageal Squamous Cell Carcinoma
- Exocrine Pancreatic Adenocarcinoma
- Gastroesophageal Junction Adenocarcinoma
- HER2 Negative Breast Neoplasms
- Ovarian Neoplasms
- Squamous Cell Carcinoma of Head and Neck
- Stomach Neoplasms
- Urinary Bladder Neoplasms
- Uterine Cervical Neoplasms
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- sigvotatug vedotin — DRUGAdministered into the vein (IV; intravenously)
- pembrolizumab — DRUG200mg every 3 weeks or 400mg every 6 weeks, given by IV
- cisplatin — DRUG75 mg/m2 every 3 weeks, given by IV
- carboplatin — DRUGAUC 5 mg/mL per min every 3 weeks, given by IV
Study Details
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.
Key Dates
- Start date
- Jun 8, 2020
- Status verified
- May 2026
- Primary completion
- Jun 16, 2027
- Completion
- Mar 22, 2029
Study Design
- Enrollment
- 1,006 participants (estimated)
- Allocation
- NA
- Intervention model
- SEQUENTIAL
- Primary purpose
- TREATMENT
Arms
- Experimental: Part A: Dose escalationsigvotatug vedotin monotherapy
- Experimental: Part B: Dose expansionsigvotatug vedotin monotherapy
- Experimental: Part C: sigvotatug vedotin combination therapy in NSCLC, HNSCC, ESCCsigvotatug vedotin + pembrolizumab +/- (carboplatin or cisplatin)
- Experimental: Part D: sigvotatug vedotin combination therapy in 1L NSCLCsigvotatug vedotin + pembrolizumab +/- (carboplatin)
- Experimental: Part D: sigvotatug vedotin combination therapy in 1L HNSCCsigvotatug vedotin + pembrolizumab +/- (carboplatin or cisplatin)
Primary Outcome Measure
Number of participants with adverse events (AEs) [ Time Frame: Through 30-37 days following last dose of sigvotatug vedotin. For participants receiving pembrolizumab up to 90 days after last dose of pembrolizumab; up to 3 years ]
Central Contacts
- Pfizer CT.gov Call Center1-800-718-1021
Locations (105)
Find similar trials in Anchorage, AK
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