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NCT05150691 · ClinicalTrials.gov registry record · Phase 1

A Phase 1/2a Study of DB-1303/BNT323 in Advanced/Metastatic Solid Tumors

A Phase 1 study of HER2-positive Advanced Solid Tumor, sponsored by DualityBio.

Recruiting
Registry status
Phase 1
Development phase
796
Enrollment target
20
Study locations

NCT05150691 is a Phase 1 study of HER2-positive Advanced Solid Tumor that is actively recruiting participants, run by DualityBio. The registered enrollment target is 796 participants. The trial reports 20 study locations across 12 states.

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The verdict

NCT05150691, a Phase 1 study of HER2-positive Advanced Solid Tumor, is actively recruiting participants, sponsored by DualityBio.

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

Study Summary

This is a dose-escalation and dose-expansion Phase 1/2a trial to evaluate the safety and tolerability of DB-1303/BNT323 in subjects with advanced solid tumors that express HER2.

Interventions

  • DRUG Itraconazole
  • DRUG Ritonavir
  • BIOLOGICAL DB-1303/BNT323
  • DRUG Pertuzumab Injection

Study Locations (20)

Florida

  • Advanced Research LLC - Coral Springs
  • The Oncology Institute of Hope and Innovation - Lakeland
  • D&H Cancer Research Center LLC - Margate
  • HCA Mercy Hospital - Miami
  • BRCR Medical Center Inc. - Plantation
  • BRCR Medical Center Inc. - Tamarac

California

  • Helios Clinical Research - Cerritos
  • California Research Institute - Los Angeles
  • Sharp Memorial Hospital - San Diego

Massachusetts

  • Massachusetts General Hospital - Boston
  • Beth Israel Deaconess Medical Center - Boston

District of Columbia

  • Washington Cancer Institute at MedStar Washington Hospital Center - Washington D.C.

Georgia

  • Southeastern Regional Medical Center, LLC - Newnan

Hawaii

  • Kapi'olani Medical Center for Women and Children - Honolulu

Illinois

  • University of Chicago - Chicago

Louisiana

  • Women's Cancer Care - Covington

Trial Details

FieldValue
Enrollment Target 796 participants
Start Date 2022-01-31
Est. Completion 2027-10
Phase Phase 1

Sponsor

DualityBio

10 total trials

What the Registry Record Tells You About NCT05150691

The ClinicalTrials.gov registry entry for NCT05150691 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 796 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is DualityBio, which has 10 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with HER2-positive Advanced Solid Tumor appearing as the primary indexed condition, and to 4 interventions - of which Itraconazole is the first listed.

NCT05150691 reports 20 study locations spanning 12 distinct geographic areas - top geographies include Florida, California, Massachusetts.

Frequently Asked Questions

What is clinical trial NCT05150691 about?

NCT05150691 is a clinical study titled "A Phase 1/2a Study of DB-1303/BNT323 in Advanced/Metastatic Solid Tumors". This is a dose-escalation and dose-expansion Phase 1/2a trial to evaluate the safety and tolerability of DB-1303/BNT323 in subjects with advanced solid tumors that express HER2.

What is the current status of trial NCT05150691?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 796 participants. The study started on 2022-01-31. Estimated completion is 2027-10.

What conditions does trial NCT05150691 study?

This clinical trial studies the following conditions: HER2-positive Advanced Solid Tumor.

What interventions are being tested in trial NCT05150691?

The interventions under investigation include: Itraconazole (DRUG), Ritonavir (DRUG), DB-1303/BNT323 (BIOLOGICAL), Pertuzumab Injection (DRUG).

Who is sponsoring clinical trial NCT05150691?

This trial is sponsored by DualityBio, which has 10 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05150691 being conducted?

This trial has 20 study locations across California, District of Columbia, Florida, Georgia, Hawaii. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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.