ClinicaliQ Trial Snapshot
- A Study to Test the Safety, Tolerability and Effect of ZI-MA4-1 for Patients With Locally Advanced or Metastatic Solid Malignancies — Recruiting • Phase I • Oncology • NCT07613723.
- What is being tested: ZI-MA4-1, a novel therapeutic agent, is undergoing evaluation for safety, tolerability, and clinical efficacy in patients with advanced solid malignancies (ovarian, squamous NSCLC, synovial sarcoma, and head and neck cancers).
- Patient eligibility overview: The trial recruits patients with inoperable locally advanced or metastatic disease across four cancer types; these represent patient populations with currently poor prognosis who have exhausted or are ineligible for standard treatment options.
Use This Page For
- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
What This Trial Is Studying
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…
Eligibility Snapshot
- : * HLA-A*02:01 positive * Tumour(s) show expression of the MAGE-A4 protein above a defined threshold * Histopathological or cytological diagnosis of inoperable Locally Advanced or Metastatic malignant disease: ovarian cancer, squamous non-small cell lung cancer (NSCLC), synovial sarcoma or head and neck cancer. * No approved therapy with demonstrated clinical benefit is indicated or available to treat the patient, or the patient is intolerant of or has refused standard of care therapy. * Documented imaging confirmed disease progression while on or within 6 months after the end of the most recent therapy. * Participant must have received ≥2 prior lines of cancer therapy except for patient with synovial sarcoma for whom ≥1 prior lines of cancer therapy. * Measurable disease according to RECIST v1.1 criteria. * ECOG performance status of 0 or 1 with no deterioration over the previous 2 weeks, and an anticipated life expectancy of >3 months * Female participants are eligible to participate if they are not pregnant or breastfeeding. Woman of childbearing potential must have negative pregnancy test and agree to use an effective contraceptive method. Other protocol defined inclusion criteria could apply.
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.