New antibody drug targets Hard-to-Treat cancers in first human trial
NCT ID NCT06636435
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-stage study tests a new drug called CBA-1205 in people with advanced solid tumors (like liver cancer or melanoma) that have not responded to other treatments. The main goal is to check the drug's safety and find the best dose. About 66 participants will receive the drug, and researchers will monitor side effects and measure how the body processes the drug.
This is an AI summary of the original study and may miss details. Read our disclaimer.
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 66 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2020
- Expected to finish
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Jun 2027
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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2 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:(Part 1-4) * Patients who provide voluntary written informed consent to participate in the study * Patients with an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of≤1 * Patients with preserved renal function as evidenced by laboratory data obtained within 7 days before enrollment (creatinine: ≤ ULN ×1.5) * Patients who meet the following laboratory criteria of bone marrow function as evidenced by laboratory data obtained within 7 days before enrollment: Neutrophil count;≥1500/μL, Platelet count; ≥75000/μL, Hemoglobin;≥9.0 g/dL. * Patients having Solid Tumors with no standard therapy available or refractory or intolerable to standard therapy (Part2, 3) * Patients with Child-Pugh A or B (Part2, 3) * Patients with Malignant Melanoma who are refractory or intolerant to standard therapy (Part 4) Inclusion Criteria:(Part 5) * Patients who provide voluntary written informed consent to participate in the study from both the subject (if aged 16 years or older) and their legal representatives * Japanese patients aged 2 years or older and under 20 years at the time of informed consent * Patients with a Lansky Performance Status (LPS) of ≥70 (for patients aged 15 years or younger) or a Karnofsky Performance Status (KPS) of ≥70 (for patients aged 16 years or older) * Patients with preserved renal function as evidenced by laboratory data obtained within 7 days before enrollment (eGFR ≥60 mL/min/1.73 m²) * Pediatric patients with cancers with no standard therapy available or refractory or intolerable to the standard therapy Exclusion criteria: (Part1-5) * Patients who have undergone major surgery within 28 days before enrollment * Patients who have received anticancer treatment with surgical therapy, radiation therapy, and/or drug therapy within 14 days before enrollment * Patients who have received anticancer treatment with immune checkpoint inhibitor, etc. within 28 days before enrollment * Patients with Grade 2 or higher concurrent disease or prior therapy-related toxicity * Patients who have received any other investigational product within 28 days before enrollment * Patients with current or previous inadequately controlled or clinically significant cardiac disease * Patients who, in the opinion of the investigator or subinvestigator, is not appropriate
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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 places running it
5 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
Locations
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Kanagawa Cancer Center
RECRUITINGYokohama, Kanagawa, 241-8515, Japan
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National Cancer Center Hospital
RECRUITINGChūō, Tokyo, 104-0045, Japan
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National Cancer Center Hospital East
RECRUITINGKashiwa, Chiba, 277-8577, Japan
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Niigata University Medical and Dental Hospital
RECRUITINGNiigata, Niigata, 951-8520, Japan
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University of Yamanashi Hospital
RECRUITINGChūō, Yamanashi, 409-3898, Japan
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can two immunotherapy drugs make liver tumors more vulnerable to surgery?
- Can a pill shrink Hard-to-Treat ovarian tumors?
- Experimental infusion drug tested against recurrent nasopharyngeal cancer
- Can a pill target tumors with the PIK3CA-H1047R mutation?
- Can a Two-Drug combo outsmart Treatment-Resistant breast cancer?
- Radioactive antibody aims to light up hidden solid tumors