Testing a new antibody treatment for advanced solid tumors and liver cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a first-in-human, multicenter, open-label Phase I study designed to evaluate the safety and tolerability of CBA-1205, an anti-DLK1 monoclonal antibody, in patients with advanced solid tumors and hepatocellular carcinoma (HCC). The study is divided into three parts: Part 1 focuses on patients with solid tumors lacking standard treatment options, Part 2 targets patients with unresectable advanced or recurrent HCC, and Part 3 assesses the efficacy of the recommended dose in the same HCC population. The study employs a standard 3+3 dose escalation methodology to determine the appropriate dosing and monitor safety outcomes.

Why it matters

Who can join: the full rules

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

Where it's running

• National Cancer Center Hospital East
  Kashiwa, Chiba, Japan Recruiting
• Kanagawa Cancer Center
  Yokohama, Kanagawa, Japan Recruiting
• Niigata University Medical and Dental Hospital
  Niigata, Niigata, Japan Recruiting
• National Cancer Center Hospital
  Chūō, Tokyo, Japan Recruiting
• University of Yamanashi Hospital
  Chūō, Yamanashi, Japan Recruiting

Study contacts

• Study coordinator: Tanaka Miseri Chiome Bioscience Inc.
• Email: ir@chiome.co.jp
• Phone: +81-3-6383-3561

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.