Testing a new antibody treatment for advanced solid tumors and liver cancer
A Phase I, First in Human Study of CBA-1205, Anti-DLK1 Monoclonal Antibody in Patients With Advanced Solid Tumors.
This study is testing a new antibody treatment for people with advanced solid tumors and liver cancer to see if it is safe and how well it works.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 66 (estimated) |
| Ages | 2 Years and up |
| Sex | All |
| Sponsor | Chiome Bioscience Inc. Industry-sponsored |
| Drugs / interventions | radiation |
| Locations | 5 sites (Kashiwa, Chiba and 4 other locations) |
| Trial ID | NCT06636435 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include patients with advanced solid tumors or unresectable hepatocellular carcinoma who are intolerable or non-responsive to standard treatments.
Not a fit: Patients with solid tumors that have effective standard treatment options or those with major surgery within the last 28 days may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced solid tumors and hepatocellular carcinoma who have limited or no treatment alternatives.
How similar studies have performed: While this approach is novel in the context of CBA-1205, similar studies targeting advanced solid tumors and HCC have shown promise in the past.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Kashiwa, Chiba and 4 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.