NCT06046742 A Study of Intravenous M1-c6v1 for Locally Advanced or Metastatic Solid Tumors
| NCT ID | NCT06046742 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Guangzhou Virotech Pharmaceutical Co., Ltd. |
| Condition | Solid Tumor |
| Study Type | INTERVENTIONAL |
| Enrollment | 12 participants |
| Start Date | 2024-07-10 |
| Primary Completion | 2026-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 12 participants in total. It began in 2024-07-10 with a primary completion date of 2026-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Contact & Investigator
Guangzhou Virotech Pharmaceutical Co., Ltd.
STUDY CHAIR
Guangzhou Virotech Pharmaceutical Co., Ltd.
Frequently Asked Questions
Who can join the NCT06046742 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Solid Tumor. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06046742 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06046742 currently recruiting?
Yes, NCT06046742 is actively recruiting participants. Contact the research team at clinicaltrialinfo@virot.cn for enrollment information.
Where is the NCT06046742 trial being conducted?
This trial is being conducted at Kashiwa-shi, Japan, Matsuyama, Japan, Kawasaki-shi, Japan.
Who is sponsoring the NCT06046742 clinical trial?
NCT06046742 is sponsored by Guangzhou Virotech Pharmaceutical Co., Ltd.. The principal investigator is Guangzhou Virotech Pharmaceutical Co., Ltd. at Guangzhou Virotech Pharmaceutical Co., Ltd.. The trial plans to enroll 12 participants.