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
NCT ID: NCT05593094
Last Updated: 2025-11-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE1/PHASE2
210 participants
INTERVENTIONAL
2020-09-03
2026-07-31
Brief Summary
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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).
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Detailed Description
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Phase 1a (Monotherapy Dose Escalation): In this first phase, participants will receive ZN-A-1041 alone. The study will begin with a low dose of ZN-A-1041, which will be gradually increased in new groups of participants to find the highest dose that can be given safely. This will establish the recommended dose for further study.
Phase 1b (Combination Dose Escalation): In the second phase, the study will evaluate the safety of giving ZN-A-1041 together with established standard-of-care therapies for HER2-positive breast cancer. Participants will be enrolled into one of three combination arms to receive ZN-A-1041 with either T-DM1, T-DXd, or a pertuzumab/trastuzumab-based regimen. This phase will identify the recommended dose for these combination therapies.
Phase 1c (Combination Dose Expansion): In the final phase, additional participants will be enrolled to receive ZN-A-1041 at the recommended combination doses identified in Phase 1b. This will allow for a more thorough evaluation of the safety and preliminary efficacy of these treatment regimens.
Throughout the study, participants will undergo screening, treatment, and follow-up periods to collect comprehensive data on the safety, tolerability, pharmacokinetics, and anti-tumor activity of ZN-A-1041, both as a single agent and in combination.
Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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1a: ZN-A-1041
Phase 1a:
Participants will receive escalating doses of ZN-A-1041 orally twice a day (BID) at pre-defined dosing regimens to determine the maximum tolerated dose (MTD).
ZN-A-1041
ZN-A-1041: escalating doses orally BID at pre-defined dosing regimens to determine the MTD
1b: ZN-A-1041 + T-DM1 3.6 mg/kg iv.
Phase 1b Arm1:
1. If the maximum tolerated dose (MTD) of ZN-A-1041 is identified in Phase 1a study: The 2 tentative dose levels of ZN-A-1041 are MTD-1 (Level 1) and MTD (Level 2).
2. If the MTD is still not reached at the maximum dose level in Phase 1a study, the maximum dose level of ZN-A-1041 in Phase 1a will be used in Phase 1b study.
ZN-A-1041 + T-DM1 3.6 mg/kg iv. for Phase 1b
ZN-A-1041: BID via oral administration T-DM1: 3.6 mg/kg given as an intravenous infusion on the first day of each treatment cycle, once every 3 weeks (21-day cycle)
1b: ZN-A-1041 + T-Dxd 5.4 mg/kg iv.
Phase 1b Arm2:
1. If the MTD of ZN-A-1041 is identified in Phase 1a study: The 2 tentative dose levels of ZN-A-1041 are MTD-1 (Level 1) and MTD (Level 2).
2. If the MTD is still not reached at the maximum dose level in Phase 1a study, the maximum dose level of ZN-A-1041 in Phase 1a will be used in Phase 1b study.
ZN-A-1041 + T-Dxd 5.4 mg/kg iv. for Phase 1b
ZN-A-1041: BID via oral administration T-DXd: 5.4 mg/kg given as an intravenous infusion on the first day of each treatment cycle, once every 3 weeks (21-day cycle)
1b: ZN-A-1041 + PHESGO / Herceptin plus Perjeta
Phase 1b Arm3:
1. If the MTD of ZN-A-1041 is identified in Phase 1a study: The 2 tentative dose levels of ZN-A-1041 are MTD-1 (Level 1) and MTD (Level 2).
2. If the MTD is still not reached at the maximum dose level in Phase 1a study, the maximum dose level of ZN-A-1041 in Phase 1a will be used in Phase 1b study.
ZN-A-1041 + PHESGO / Herceptin plus Perjeta injection for Phase 1b
ZN-A-1041: BID via oral administration PHESGO dose is 600 mg pertuzumab/600 mg trastuzumab/2000 unites hyaluronidase every 3 weeks for subcutaneous administrations (21-day cycle) Perjeta is 420 mg administered as an intravenous infusion Herceptin is 6 mg/kg administered as an intravenous infusion
1c: ZN-A-1041 + T-DM1 3.6 mg/kg iv.
Phase 1c Arm1:
The recommended dose combination for Phase 1c will be determined by the Investigator and the Sponsor based on the data from Phase 1b.
ZN-A-1041 + T-DM1 3.6 mg/kg iv. for Phase 1c
ZN-A-1041: BID via oral administration T-DM1: intravenous infusion on the first day of each treatment cycle, once every 3 weeks (21-day cycle)
1c: ZN-A-1041 + T-Dxd 5.4 mg/kg iv.
Phase 1c Arm2:
The recommended dose combination for Phase 1c will be determined by the Investigator and the Sponsor based on the data from Phase 1b.
ZN-A-1041 + T-Dxd 5.4 mg/kg iv. for Phase 1c
ZN-A-1041: BID via oral administration T-DXd: intravenous infusion on the first day of each treatment cycle, once every 3 weeks (21-day cycle)
1c: ZN-A-1041 + Herceptin plus Perjeta/PHESGO
Phase 1c Arm3:
The recommended dose combination for Phase 1c will be determined by the Investigator and the Sponsor based on the data from Phase 1b.
ZN-A-1041 + PHESGO / Herceptin plus Perjeta injection for Phase 1c
ZN-A-1041: BID via oral administration PHESGO: every 3 weeks for subcutaneous administrations (21-day cycle) Perjeta: intravenous infusion Herceptin: intravenous infusion
Interventions
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ZN-A-1041
ZN-A-1041: escalating doses orally BID at pre-defined dosing regimens to determine the MTD
ZN-A-1041 + T-DM1 3.6 mg/kg iv. for Phase 1b
ZN-A-1041: BID via oral administration T-DM1: 3.6 mg/kg given as an intravenous infusion on the first day of each treatment cycle, once every 3 weeks (21-day cycle)
ZN-A-1041 + T-Dxd 5.4 mg/kg iv. for Phase 1b
ZN-A-1041: BID via oral administration T-DXd: 5.4 mg/kg given as an intravenous infusion on the first day of each treatment cycle, once every 3 weeks (21-day cycle)
ZN-A-1041 + PHESGO / Herceptin plus Perjeta injection for Phase 1b
ZN-A-1041: BID via oral administration PHESGO dose is 600 mg pertuzumab/600 mg trastuzumab/2000 unites hyaluronidase every 3 weeks for subcutaneous administrations (21-day cycle) Perjeta is 420 mg administered as an intravenous infusion Herceptin is 6 mg/kg administered as an intravenous infusion
ZN-A-1041 + T-DM1 3.6 mg/kg iv. for Phase 1c
ZN-A-1041: BID via oral administration T-DM1: intravenous infusion on the first day of each treatment cycle, once every 3 weeks (21-day cycle)
ZN-A-1041 + T-Dxd 5.4 mg/kg iv. for Phase 1c
ZN-A-1041: BID via oral administration T-DXd: intravenous infusion on the first day of each treatment cycle, once every 3 weeks (21-day cycle)
ZN-A-1041 + PHESGO / Herceptin plus Perjeta injection for Phase 1c
ZN-A-1041: BID via oral administration PHESGO: every 3 weeks for subcutaneous administrations (21-day cycle) Perjeta: intravenous infusion Herceptin: intravenous infusion
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Life expectancy of at least 6 months, as determined by the investigator
* Histologically or cytologically confirmed with unresectable or metastatic HER2-positive advanced solid tumors
* Must be relapsed or refractory after prior treatment for metastatic disease that included a taxane and trastuzumab or must have received first-line induction therapy for advanced disease a pertuzumab plus trastuzumab-based regimen or a T-DXd-based regimen
* Participants with new, untreated, progressive, or stable brain metastases are eligible
Exclusion Criteria
* Any intracranial lesion (brain metastasis) that requires immediate local therapy, such as surgery or radiation, or systemic corticosteroids at the time of enrollment
18 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Arizona Clinical Research Center, Inc.;Hematology Oncology Physicians - Aoa
Tucson, Arizona, United States
TOI Clinical Research
Cerritos, California, United States
UCSF Helen Diller Family CCC
San Francisco, California, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
University of Michigan Hospital
Ann Arbor, Michigan, United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States
Duke University School of Medicine
Durham, North Carolina, United States
MD Anderson Cancer Center
Houston, Texas, United States
Geelong Hospital
Geelong, Victoria, Australia
Sunshine Hospital
St Albans, Victoria, Australia
EDOG - Institut Claudius Regaud - PPDS
Toulouse, Haute-Garonne, France
Centre Georges Francois Leclerc
Dijon, , France
Centre Oscar Lambret
Lille, , France
Centre Léon Bérard Centre Régional de Lutte Contre Le Cancer Rhône Alpes
Lyon, , France
Institut Paoli-Calmettes
Marseille, , France
Institut de Cancerologie de l Ouest
Saint-Herblain, , France
Gustave Roussy
Villejuif, , France
Istituto Romagnolo per lo Studio dei Tumori Dino Amadori - IRST S.r.l - PPDS
Parma, Emilia-Romagna, Italy
Asst Papa Giovanni XXIII
Bergamo, Lombardy, Italy
Fondazione Policlinico Universitario A Gemelli-Rome
Magnago, Lombardy, Italy
Auckland City Hospital
Auckland, , New Zealand
Instituto de Investigacion Oncologica Vall dHebron (VHIO) - EPON
Argentona, Barcelona, Spain
Hospital Clinico Universitario de Santiago
Santiago de Compostela, LA Coruna, Spain
Hospital Universitario Ramon y Cajal
A Gudiña, Orense, Spain
Hospital Universitario Virgen del Rocio
Las Cabezas de San Juan, Sevilla, Spain
Instituto Oncologico Dr. Rosell-Hospital Universitari Dexeus-Grupo Quironsalud
Barcelona, , Spain
Hospital Clinic de Barcelona
Barcelona, , Spain
Hospital Universitario de Jaen
Jaén, , Spain
Hospital Beata Maria Ana
Madrid, , Spain
Hospital Clinico San Carlos
Madrid, , Spain
Hospital Universitario 12 de Octubre
Madrid, , Spain
Hospital Universitario Virgen Macarena
Seville, , Spain
Fundacion Instituto Valenciano de Oncologia (IVO)
Valencia, , Spain
Hospital Clinico Universitario de Valencia
Valencia, , Spain
The Christie
Manchester, Lancashire, United Kingdom
Clatterbridge Cancer Centre
Liverpool, Merseyside, United Kingdom
Countries
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Other Identifiers
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ZN-A-1041-101-US
Identifier Type: OTHER
Identifier Source: secondary_id
2023-508459-37-00
Identifier Type: CTIS
Identifier Source: secondary_id
XO45189
Identifier Type: -
Identifier Source: org_study_id
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