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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 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.

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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.

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

Sponsor

Seagen, a wholly owned subsidiary of Pfizer

28 total trials

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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, categorized as Phase 1. The registered enrollment target is 1,006 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 316-participant average among 130 other Carcinoma, Non-Small Cell Lung trials with a reported enrollment target (218% higher). The listed sponsor is Seagen, a wholly owned subsidiary of Pfizer, which has 28 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 4 distinct geographic areas - top geographies include 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.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.