Clinical trial · Interventional
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 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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
| HER2-positive Breast Cancer | HER2-Positive Breast Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (7)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ZN-A-1041 | Drug | — | UNRESOLVED |
| ZN-A-1041 + PHESGO / Herceptin plus Perjeta injection for Phase 1b | Drug | — | UNRESOLVED |
| ZN-A-1041 + PHESGO / Herceptin plus Perjeta injection for Phase 1c | Drug | — | UNRESOLVED |
| ZN-A-1041 + T-DM1 3.6 mg/kg iv. for Phase 1b | Drug | — | UNRESOLVED |
| ZN-A-1041 + T-DM1 3.6 mg/kg iv. for Phase 1c | Drug | — | UNRESOLVED |
| ZN-A-1041 + T-Dxd 5.4 mg/kg iv. for Phase 1b | Drug | — | UNRESOLVED |
| ZN-A-1041 + T-Dxd 5.4 mg/kg iv. for Phase 1c | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (7)
- type
- EXPERIMENTAL
- label
- 1a: ZN-A-1041
- description
- 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).
- interventionNames
- Drug: ZN-A-1041
- type
- EXPERIMENTAL
- label
- 1b: ZN-A-1041 + T-DM1 3.6 mg/kg iv.
- description
- 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.
- interventionNames
- Drug: ZN-A-1041 + T-DM1 3.6 mg/kg iv. for Phase 1b
- type
- EXPERIMENTAL
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available