A Phase 1 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of ZN-A-1041 Enteric Capsules as a Single Agent or in Combination in Patients with 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 (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).

Inclusion Criteria:

- 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

Exclusion Criteria:

- 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