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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: Active Phase 1 study of Advanced Solid Tumors and HER2-positive Breast Cancer, sponsored by Hoffmann-La Roche.
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. According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
Dose at which no more than one out of six participant at the same dose level experiences a probable drug-related DLT.
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 |
What the registry record for NCT05593094 still lists
NCT05593094 is an interventional study that assigns participants to a tested intervention. The registered 210 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 197-participant average among 144 other Advanced Solid Tumors trials with a reported enrollment target.
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 names 20 study sites across 11 states, led by 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.
Learn More About Clinical Trials
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Where NCT05593094's enrollment target sits among peer trials
210 42nd of 144 higher than 102 of 144 other Advanced Solid Tumors trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Advanced Solid Tumors 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.
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