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NCT04389632 · ClinicalTrials.gov registry record · Phase 1

A Study of Sigvotatug Vedotin in Advanced Solid Tumors

A Phase 1 study of Carcinoma, Non-Small Cell Lung and Esophageal Adenocarcinoma, sponsored by Seagen, a wholly owned subsidiary of Pfizer.

Recruiting
Registry status
Phase 1
Development phase
1,006
Enrollment target
20
Study locations

NCT04389632: Recruiting Phase 1 study of Carcinoma, Non-Small Cell Lung and Esophageal Adenocarcinoma, sponsored by Seagen, a wholly owned subsidiary of Pfizer.

NCT04389632 is a Phase 1 study of Carcinoma, Non-Small Cell Lung and Esophageal Adenocarcinoma that is actively recruiting participants, run by Seagen, a wholly owned subsidiary of Pfizer. The registered enrollment target is 1,006 participants, above the 316-participant average among 130 other Carcinoma, Non-Small Cell Lung trials with a reported enrollment target (218% higher). The trial reports 20 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04389632, a Phase 1 study of Carcinoma, Non-Small Cell Lung and Esophageal Adenocarcinoma, is actively recruiting participants, sponsored by Seagen, a wholly owned subsidiary of Pfizer.

RECRUITING
Registry status
Phase 1
Development phase
1,006 participants
Enrollment target
20
Study locations

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.

Primary Outcome

Any untoward medical occurrence in a clinical investigational participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment.

Conditions Studied

Carcinoma, Non-Small Cell Lung Esophageal Adenocarcinoma Gastroesophageal Junction Adenocarcinoma Ovarian Neoplasms Squamous Cell Carcinoma of Head and Neck Esophageal Squamous Cell Carcinoma Urinary Bladder Neoplasms Cutaneous Squamous Cell Cancer HER2 Negative Breast Neoplasms Exocrine Pancreatic Adenocarcinoma

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

FieldValue
Enrollment Target 1,006 participants
Start Date 2020-06-08
Est. Completion 2029-03-22
Phase Phase 1
Seagen, a wholly owned subsidiary of Pfizer

28 total trials

What NCT04389632 shows while recruiting

NCT04389632 is an interventional study that assigns participants to a tested intervention. Its 1,006 participants enrollment target places it among the larger protocols in the corpus, above the 316-participant average among 130 other Carcinoma, Non-Small Cell Lung trials with a reported enrollment target (218% higher).

The record links to 10 conditions, with Carcinoma, Non-Small Cell Lung appearing as the primary indexed condition, and to 4 interventions - of which pembrolizumab is the first listed.

NCT04389632 names 20 study sites across 4 states, led by California, Florida, Arkansas.

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: Carcinoma, Non-Small Cell Lung, Esophageal Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma, Ovarian Neoplasms, Squamous Cell Carcinoma of Head and Neck.

What interventions are being tested in trial NCT04389632?

The interventions under investigation include: pembrolizumab (DRUG), sigvotatug vedotin (DRUG), cisplatin (DRUG), carboplatin (DRUG).

Who is sponsoring clinical trial NCT04389632?

This trial is sponsored by Seagen, a wholly owned subsidiary of Pfizer, which has 28 total clinical trials registered on ClinicalTrials.gov.

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.

Learn More About Clinical Trials

Similar trials for Carcinoma, Non-Small Cell Lung

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT04389632's enrollment target sits among peer trials

1,006 6th of 130 higher than 125 of 130 other Carcinoma, Non-Small Cell Lung trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Carcinoma, Non-Small Cell Lung trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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More recruiting context for NCT04389632

Source: ClinicalTrials.gov NCT04389632, the US trial registry maintained by the National Library of Medicine. NCT04389632 (large enrollment · wide site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.