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NCT05593094 · ClinicalTrials.gov registry record · Phase 1
A Phase 1 Trial of ZN-A-1041 Enteric Capsules or Combination in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Advanced Solid Tumors
A Phase 1 study of Advanced Solid Tumors and HER2-positive Breast Cancer, sponsored by Hoffmann-La Roche.
- Active
- Registry status
- Phase 1
- Development phase
- 210
- Enrollment target
- 20
- Study locations
NCT05593094 is a Phase 1 study of Advanced Solid Tumors and HER2-positive Breast Cancer that is active but no longer recruiting, run by Hoffmann-La Roche. The registered enrollment target is 210 participants, roughly in line with the 197-participant average among 144 other Advanced Solid Tumors trials with a reported enrollment target. The trial reports 20 study locations across 11 states.
The verdict
NCT05593094, a Phase 1 study of Advanced Solid Tumors and HER2-positive Breast Cancer, is active but no longer recruiting, sponsored by Hoffmann-La Roche.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 210 participants
- Enrollment target
- 20
- Study locations
Study Summary
This will be a Phase 1, multicenter, open-label trial to evaluate the safety, tolerability, PK and efficacy of ZN-A-1041 as a monotherapy or in combination in participants with HER2-positive advanced solid tumors with or without brain metastases. The study will consist of three phases: Phase 1a (dose escalation with ZN-A-1041 monotherapy), Phase 1b (dose escalation with ZN-A-1041 combination therapy) and Phase 1c (dose expansion with ZN-A-1041 combination therapy).
Conditions Studied
Interventions
- DRUG ZN-A-1041
- DRUG ZN-A-1041 + T-DM1 3.6 mg/kg iv. for Phase 1b
- DRUG ZN-A-1041 + T-Dxd 5.4 mg/kg iv. for Phase 1b
- DRUG ZN-A-1041 + PHESGO / Herceptin plus Perjeta injection for Phase 1b
- DRUG ZN-A-1041 + T-DM1 3.6 mg/kg iv. for Phase 1c
Study Locations (20)
Other
- Centre Georges Francois Leclerc - Dijon
- Centre Oscar Lambret - Lille
- Centre Léon Bérard Centre Régional de Lutte Contre Le Cancer Rhône Alpes - Lyon
- Institut Paoli-Calmettes - Marseille
- Institut de Cancerologie de l Ouest - Saint-Herblain
- Gustave Roussy - Villejuif
California
- TOI Clinical Research - Cerritos
- UCSF Helen Diller Family CCC - San Francisco
Michigan
- University of Michigan Hospital - Ann Arbor
- Barbara Ann Karmanos Cancer Institute - Detroit
Victoria
- Geelong Hospital - Geelong
- Sunshine Hospital - St Albans
Lombardy
- Asst Papa Giovanni XXIII - Bergamo
- Fondazione Policlinico Universitario A Gemelli-Rome - Magnago
Arizona
- Arizona Clinical Research Center, Inc.;Hematology Oncology Physicians - Aoa - Tucson
Massachusetts
- Dana Farber Cancer Institute - Boston
North Carolina
- Duke University School of Medicine - Durham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 210 participants |
| Start Date | 2020-09-03 |
| Est. Completion | 2027-07-31 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05593094
The ClinicalTrials.gov registry entry for NCT05593094 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 210 participants, a figure that helps gauge the scale of data the investigators plan to collect, roughly in line with the 197-participant average among 144 other Advanced Solid Tumors trials with a reported enrollment target. The listed sponsor is Hoffmann-La Roche, which has 909 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Advanced Solid Tumors appearing as the primary indexed condition, and to 5 interventions - of which ZN-A-1041 is the first listed.
NCT05593094 reports 20 study locations spanning 11 distinct geographic areas - top geographies include Other, California, Michigan.
Frequently Asked Questions
What is clinical trial NCT05593094 about?
NCT05593094 is a clinical study titled "A Phase 1 Trial of ZN-A-1041 Enteric Capsules or Combination in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Advanced Solid Tumors". This will be a Phase 1, multicenter, open-label trial to evaluate the safety, tolerability, PK and efficacy of ZN-A-1041 as a monotherapy or in combination in participants with HER2-positive advanced solid tumors with or without brain metastases. The study will consist of three phases: Phase 1a (do...
What is the current status of trial NCT05593094?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 210 participants. The study started on 2020-09-03. Estimated completion is 2027-07-31.
What conditions does trial NCT05593094 study?
This clinical trial studies the following conditions: Advanced Solid Tumors, HER2-positive Breast Cancer.
What interventions are being tested in trial NCT05593094?
The interventions under investigation include: ZN-A-1041 (DRUG), ZN-A-1041 + T-DM1 3.6 mg/kg iv. for Phase 1b (DRUG), ZN-A-1041 + T-Dxd 5.4 mg/kg iv. for Phase 1b (DRUG), ZN-A-1041 + PHESGO / Herceptin plus Perjeta injection for Phase 1b (DRUG), ZN-A-1041 + T-DM1 3.6 mg/kg iv. for Phase 1c (DRUG).
Who is sponsoring clinical trial NCT05593094?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05593094 being conducted?
This trial has 20 study locations across Arizona, California, Massachusetts, Michigan, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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