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New antibody drug targets Hard-to-Treat cancers in first human trial

NCT ID NCT06636435

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 66 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2020

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

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

2 years and older

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    5 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Kanagawa Cancer Center

    RECRUITING

    Yokohama, Kanagawa, 241-8515, Japan

  • National Cancer Center Hospital

    RECRUITING

    Chūō, Tokyo, 104-0045, Japan

  • National Cancer Center Hospital East

    RECRUITING

    Kashiwa, Chiba, 277-8577, Japan

  • Niigata University Medical and Dental Hospital

    RECRUITING

    Niigata, Niigata, 951-8520, Japan

  • University of Yamanashi Hospital

    RECRUITING

    Chūō, Yamanashi, 409-3898, Japan

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