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A Study of Sigvotatug Vedotin in Advanced Solid Tumors
NCT04389632 · View on ClinicalTrials.gov ↗
Study 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 Studied
Interventions
- DRUG pembrolizumab
- DRUG sigvotatug vedotin
- DRUG cisplatin
- DRUG carboplatin
Study Locations (20)
California
- Providence Medical Foundation — Anaheim
- Providence Medical Foundation — Fullerton
- Providence St. Jude Medical Center Virginia K Crosson and Infusion Center — Fullerton
- Cancer and Blood Research Center, LLC — Los Alamitos
- Cancer and Blood Specialty Clinic — Los Alamitos
- Ronald Reagan UCLA Medical Center — Los Angeles
- The Regents of the University of California — Los Angeles
- UCLA Department of Medicine-Hematology/Oncology — Los Angeles
- UCLA Department of Medicine - Hematology & Oncology — Santa Monica
- Cancer AND Blood Specialty Clinic — Torrance
Florida
- American Oncology Partners, PA. a Florida professional service corporation, d/b/a Vista Oncology — Fort Myers
- Florida Cancer Specialists & Research Institute, LLC — Fort Myers
- Memorial Cancer Institute — Hollywood
- Memorial Healthcare System — Hollywood
- Florida Cancer Specialists — Orlando
- Memorial Cancer Institute at Memorial Hospital West — Pembroke Pines
Arkansas
- Highlands Oncology Group — Fayetteville
- Highlands Oncology Group — Rogers
- Highlands Oncology Group — Springdale
Alaska
- Alaska Oncology and Hematology — Anchorage
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,006 participants |
| Start Date | 2020-06-08 |
| Est. Completion | 2029-03-22 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04389632
The ClinicalTrials.gov registry entry for NCT04389632 describes a study currently listed as recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 1,006 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Seagen, a wholly owned subsidiary of Pfizer, which has 51 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 10 conditions, with Esophageal Adenocarcinoma appearing as the primary indexed condition, and to 4 interventions — of which pembrolizumab is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04389632 reports 20 study locations spanning 4 distinct geographic areas — top geographies include California, Florida, Arkansas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT04389632 about?
NCT04389632 is a clinical study titled "A Study of Sigvotatug Vedotin 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 d...
What is the current status of trial NCT04389632?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 1,006 participants. The study started on 2020-06-08. Estimated completion is 2029-03-22.
What conditions does trial NCT04389632 study?
This clinical trial studies the following conditions: Esophageal Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma, Ovarian Neoplasms, Squamous Cell Carcinoma of Head and Neck, Esophageal Squamous Cell Carcinoma. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04389632?
The interventions under investigation include: pembrolizumab (DRUG), sigvotatug vedotin (DRUG), cisplatin (DRUG), carboplatin (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04389632?
This trial is sponsored by Seagen, a wholly owned subsidiary of Pfizer, which has 51 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04389632 being conducted?
This trial has 20 study locations across Alaska, Arkansas, California, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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