A Study to Test the Safety, Tolerability and Effect of ZI-MA4-1 for Patients With Locally Advanced or Metastatic Solid Malignancies
- Status
- RECRUITING
- Phase
- PHASE1
- Last update posted
- 09/04/2026
- Start
- 05/11/2026
- Sponsor
- Zelluna Immunotherapy AS
- Specialties
- otolaryngology, oncology
Conditions: Ovarian Cancer; Squamous Non-Small Cell Lung Cancer (NSCLC); Synovial Sarcomas; Head and Neck Cancer
Brief summary
This study will recruit patients with the following cancer indications: ovarian cancer, squamous non-small cell lung cancer, synovial sarcoma and head and neck cancer, with inoperable locally advanced or metastatic solid tumours. Currently, these patients have a poor prognosis and a relatively short overall survival. There is a lack of meaningful, effective therapies available that improve the outcome for these patients. The treatment being investigated in this study is ZIMA4-1, an allogeneic cell therapy product. This is the first time ZI-MA4-1 will be administered to humans. The study is planned to consist of two parts (A and B). Part A includes up to four dose escalation cohorts and aims to identify the maximum tolerated dose of ZI-MA4-1 and give insight into the recommended Phase 2 dose (RP2D). Part B consists of an expansion cohort and is designed to further evaluate the RP2D identified in Part A across one or more indications. The study procedures and eligibility criteria will be the same for participants in Parts A and B, except for the dose level of ZI-MA4-1.
Protocol documents and results are not hosted here. Verify every detail on ClinicalTrials.gov.
