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Clinical Trials in Japan / NCT06046742
Recruiting Phase 1

A Study of Intravenous M1-c6v1 for Locally Advanced or Metastatic Solid Tumors

NCT06046742 · tracked via the Priya Life Science Japan tracker
Phase
Phase 1
Started
2024-07-10
Last updated
2026-09-11

Condition(s) studied

Solid Tumor

Investigational drug(s) / intervention(s)

M1-c6v1

M1-c6v1: Intravenous drip administration

Study summary

A Phase I Study of the Safety and Tolerability of M1-c6v1 Administered Via Intravenously for Treatment of Patients With Locally Advanced or Metastatic Solid Tumors

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. Subjects must have diagnosis of locally advanced or metastatic solid tumors who are intolerable or refractory to the standard therapy. 2. Subject voluntarily agrees to participate in this study and signs an Institutional Review Board -approved informed consent prior to performing any of the Screening Visit procedures. 3. Males and females at least 18 years of age, inclusive, at the Screening Visit. 4. Have at least one measurable lesion. 5. An Eastern Cooperative Oncology Group (ECOG) score of 0-1, 1 week before the first administration of IMP. 6. An estimated survival time of ≥ 12 weeks. Exclusion Criteria: 1. Subject has a history of primary or acquired immunodeficient states, leukemia, lymphoma, acquired immunodeficiency syndrome (AIDS) or other clinical manifestations of infection with human immunodeficiency viruses, and those on immunosuppressive therapy. 2. Subject has received any anti-tumor treatment 4 weeks before using the IMP, including chemotherapy, biological therapy, endocrine therapy, targeted therapy, immunotherapy. 3. Subject has received systemic glucocorticoids (prednisone \>10 mg/day or equivalent doses of similar drugs) or other immunosuppressive agents within 14 days prior to first administration of IMP. 4. Subject has received immunomodulatory drugs, including but not limited to thymosin, IL-2, IFN, etc. within 14 days prior to first administration of IMP.

Primary outcome measure(s)

Trial sites (3)

FacilityCityRegionStatus
National Cancer Center Hospital East Kashiwa-shi Chiba Recruiting
National Hospital Organization Shikoku Cancer Center Matsuyama Ehime Recruiting
St. Marianna University Hospital Kawasaki-shi Kanagawa Recruiting

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06046742 on ClinicalTrials.gov ↗ ← All trials in Japan