Trials / Terminated
TerminatedNCT05588609
Study Evaluating Zenocutuzumab in Patients With or Without Molecularly Defined Cancers
A Phase 2 Study Evaluating Activity of Zenocutuzumab (MCLA-128) in Patients With or Without Molecularly Defined Cancers
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 13 (actual)
- Sponsor
- Merus B.V. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a Phase II, open-label, 2-arm, multicenter, international study designed to evaluate the efficacy of zenocutuzumab alone or in combination in patients with the following diagnoses: Group A: NRG1+ NSCLC Group B: mCRPC
Detailed description
Study Design: This is an open label (all participants know the identity of the study drug), multicenter (more than one study site), study consisting of 2 parts: Group A (NRG1+ NSCLC): Approximately 50 NRG1+NSCLC patients will be enrolled and will receive zenocutuzumab in combination with afatinib 40 mg orally once daily. Group B (mCRPC): Up to 40 mCRPC patients will be enrolled and will receive zenocutuzumab in combination with the AR targeting agent enzalutamide or abiraterone on which they experienced disease progression immediately before study entry. For the administration of zenocutuzumab in combination in Groups A and B, the Treatment Period will include 2 phases, an initial safety run-in phase, and an expansion phase with an interim efficacy analysis. The study will consist of 4 periods: Screening, Treatment, Safety Follow-up, and Long-term Follow up.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Afatinib Oral Tablet | anti epidermal growth factor receptor (EGFR)/HER2 agent |
| DRUG | Enzalutamide Pill | second-generation androgen receptor antagonist |
| DRUG | Abiraterone acetate tablets | androgen synthesis inhibitor |
| BIOLOGICAL | MCLA-128 | full length IgG1 bispecific antibody targeting HER2 and HER3 |
Timeline
- Start date
- 2022-11-17
- Primary completion
- 2025-07-03
- Completion
- 2025-07-03
- First posted
- 2022-10-20
- Last updated
- 2025-09-18
Locations
7 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05588609. Inclusion in this directory is not an endorsement.