This study is in progress, not accepting new patients

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 study on Solid Tumor Breast Cancer HER2 Brain Cancer Brain Tumor

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Francisco 5391959, California 5332921 and other locations
Dates
study started
study ends around
Principal Investigator
by Laura Huppert
Headshot of Laura Huppert
Laura Huppert

Description

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).

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

Details

This study is composed of three parts designed to evaluate the safety and efficacy of ZN-A-1041 in participants with HER2-positive advanced solid tumors.

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.

Keywords

Advanced Solid Tumors, HER2-positive Breast Cancer, Phase 1, HER2 postive, Brain metastases, Herceptin, Perjeta, PHESGO, First Line, 1st Line, Brain Neoplasms, Ado-Trastuzumab Emtansine, Trastuzumab, pertuzumab, ZN-A-1041 + T-DM1 3.6 mg/kg iv. for Phase 1b, ZN-A-1041 + T-Dxd 5.4 mg/kg iv. for Phase 1b, ZN-A-1041 + PHESGO / Herceptin plus Perjeta injection for Phase 1b, ZN-A-1041 + T-DM1 3.6 mg/kg iv. for Phase 1c, ZN-A-1041 + T-Dxd 5.4 mg/kg iv. for Phase 1c, ZN-A-1041 + PHESGO / Herceptin plus Perjeta injection for Phase 1c

Eligibility

You can join if…

Open to people ages 18 years and up

  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • 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

You CAN'T join if...

  • Participation in any other clinical study involving an investigational drug or device within 4 weeks prior to the first dose of study treatment
  • Any intracranial lesion (brain metastasis) that requires immediate local therapy, such as surgery or radiation, or systemic corticosteroids at the time of enrollment

Locations

  • UCSF Helen Diller Family CCC
    San Francisco 5391959 California 5332921 94158 United States
  • TOI Clinical Research
    Cerritos 5335663 California 5332921 90703-2684 United States

Lead Scientist at UCSF

  • Laura Huppert
    Dr. Laura Huppert is an oncologist who cares for patients with all stages of breast cancer. Huppert's research focuses on designing and conducting clinical trials to evaluate new cancer treatments, including ways to combine therapies so as to improve outcomes.

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Hoffmann-La Roche
ID
NCT05593094
Phase
Phase 1/2 research study
Study Type
Interventional
Participants
Expecting 210 study participants
Last Updated