Experimental biologic M1-c6v1 put to the test in Hard-to-Treat solid tumors
NCT ID NCT06046742
First seen Sep 11, 2026 · Last updated Sep 11, 2026
Summary
Researchers are testing an experimental intravenous biologic called M1-c6v1 in adults with locally advanced or metastatic solid tumors that have not responded to standard treatment. The Phase I trial gives escalating doses to a small group of participants to check safety, find the highest dose people can tolerate, and measure how the body handles the drug. Participants receive M1-c6v1 by intravenous drip, and researchers track side effects and dose-limiting toxicities to decide a dose for future studies.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- an experimental intravenous biologic called M1-c6v1
- What this could lead to
- If it works, this could point toward a new treatment option for people whose advanced solid tumors have stopped responding to standard therapy.
- What could go wrong
- This is a first-in-human Phase I trial with about 12 participants, so its main goal is checking safety and dosing, not proving the drug works. Most early-stage cancer drugs do not make it to later trials, and intravenous biologics can cause immune reactions or other side effects.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 12 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2024
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
3 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Show contact details
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Study contacts
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Contact
Email: •••••@•••••
Locations
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National Cancer Center Hospital East
RECRUITINGKashiwa-shi, Chiba, Japan
Contact Email: •••••@•••••
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National Hospital Organization Shikoku Cancer Center
RECRUITINGMatsuyama, Ehime, Japan
Contact Email: •••••@•••••
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St. Marianna University Hospital
RECRUITINGKawasaki-shi, Kanagawa, Japan
Contact Email: •••••@•••••
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- Engineered immune cells target two markers on Hard-to-Treat tumors