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New treatment option for Solid Tumor
Official title A Study of Intravenous M1-c6v1 for Locally Advanced or Metastatic Solid Tumors
ClinicalTrials.gov ID: NCT06046742
What this study is testing
What is M1-c6v1?
M1-c6v1 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for solid tumor.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- people must have diagnosis of locally advanced or metastatic solid tumors who are intolerable or refractory to the standard therapy.
- Subject voluntarily agrees to participate in this study and signs an Institutional Review Board -approved informed consent prior to performing any of...
- Males and females at least 18 years of age, inclusive, at the Screening Visit.
- Have at least one measurable lesion.
- An Eastern Cooperative Oncology Group (ECOG) score of 0-1, 1 week before the first administration of IMP.
You likely can't join if
- Subject has a history of primary or acquired immunodeficient states, leukemia, lymphoma, acquired immunodeficiency syndrome (AIDS) or other clinical...
- Subject has received any anti-tumor treatment 4 weeks before using the IMP, including chemotherapy, biological therapy, endocrine therapy, targeted...
- Subject has received systemic glucocorticoids (prednisone \>10 mg/day or equivalent doses of similar drugs) or other immunosuppressive agents within...
- Subject has received immunomodulatory drugs, including but not limited to thymosin, IL-2, IFN, etc. within 14 days prior to first administration of...
See the full eligibility criteria
- people must have diagnosis of locally advanced or metastatic solid tumors who are intolerable or refractory to the standard therapy.
- 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.
- Males and females at least 18 years of age, inclusive, at the Screening Visit.
- Have at least one measurable lesion.
- An Eastern Cooperative Oncology Group (ECOG) score of 0-1, 1 week before the first administration of IMP.
- An estimated survival time of ≥ 12 weeks.
- 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...
- Subject has received any anti-tumor treatment 4 weeks before using the IMP, including chemotherapy, biological therapy, endocrine therapy, targeted therapy, immunotherapy.
- 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.
- Subject has received immunomodulatory drugs, including but not limited to thymosin, IL-2, IFN, etc. within 14 days prior to first administration of IMP.
The study team makes the final eligibility decision.
Where it's taking place
- Kashiwa-shi, Chiba, Japan
- Matsuyama, Ehime, Japan
- Kawasaki-shi, Kanagawa, Japan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Kashiwa-shi, Chiba, Japan; Matsuyama, Ehime, Japan; Kawasaki-shi, Kanagawa, Japan. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.