ACTIVE_NOT_RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

A Phase 1 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), and Efficacy of ZN-A-1041 Enteric Capsules as a Single Agent or in Combination in Patients With HER2-Positive Advanced Solid Tumors

Quick Facts

Study Start:2020-09-03
Study Completion:2026-10-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05593094

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  2. * Life expectancy of at least 6 months, as determined by the investigator
  3. * Histologically or cytologically confirmed with unresectable or metastatic HER2-positive advanced solid tumors
  4. * 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
  5. * Participants with new, untreated, progressive, or stable brain metastases are eligible
  1. * Participation in any other clinical study involving an investigational drug or device within 4 weeks prior to the first dose of study treatment
  2. * Any intracranial lesion (brain metastasis) that requires immediate local therapy, such as surgery or radiation, or systemic corticosteroids at the time of enrollment

Contacts and Locations

Principal Investigator

Clinical Trials
STUDY_DIRECTOR
Hoffmann-La Roche

Study Locations (Sites)

Arizona Clinical Research Center, Inc.;Hematology Oncology Physicians - Aoa
Tucson, Arizona, 85712
United States
TOI Clinical Research
Cerritos, California, 90703-2684
United States
UCSF Helen Diller Family CCC
San Francisco, California, 94158
United States
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
United States
University of Michigan Hospital
Ann Arbor, Michigan, 48109
United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201
United States
Duke University School of Medicine
Durham, North Carolina, 27710
United States
MD Anderson Cancer Center
Houston, Texas, 77030-4000
United States

Collaborators and Investigators

Sponsor: Hoffmann-La Roche

  • Clinical Trials, STUDY_DIRECTOR, Hoffmann-La Roche

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-09-03
Study Completion Date2026-10-30

Study Record Updates

Study Start Date2020-09-03
Study Completion Date2026-10-30

Terms related to this study

Keywords Provided by Researchers

  • Phase 1
  • Advanced Solid Tumors
  • HER2 postive
  • Brain metastases
  • Herceptin
  • Perjeta
  • PHESGO
  • First Line
  • 1st Line

Additional Relevant MeSH Terms

  • Advanced Solid Tumors
  • HER2-positive Breast Cancer