What is CBA-1205 studying for advanced solid tumors and pediatric cancers?

CBA-1205 is being studied to evaluate its safety and tolerability in patients with advanced solid tumors, liver cancer, melanoma, and pediatric cancers. The study aims to understand how this antibody works in these conditions. It is sponsored by Chiome Bioscience Inc. and helps researchers learn about this treatment's effects.

Who may be eligible for this advanced solid tumors and pediatric cancers clinical trial?

Eligible participants are 2 years or older with advanced solid tumors, hepatocellular carcinoma, malignant melanoma, or pediatric cancer. They should have a good performance status and preserved kidney function. People who have recently had major surgery or anticancer treatments may not qualify. Please review eligibility criteria for more details.

Is there any cost to participate in this advanced solid tumors and pediatric cancers clinical trial?

Study-related care, including the study drug and all trial visits, is provided at no cost. However, personal travel expenses may vary and are not guaranteed to be covered. Participants should plan accordingly for any travel or accommodation costs.

Actively Recruiting

Phase 1

Age: 2Years +

All Genders

ID06636435

Study of CBA-1205 Antibody for Advanced Solid Tumors, Liver Cancer, Melanoma, and Pediatric Cancers Evaluating Safety and Tolerability

Led by Chiome Bioscience Inc. · Updated on 2026-06-17

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating CBA-1205, an anti-DLK1 monoclonal antibody, in a first-in-human Phase I study involving patients with advanced solid tumors, hepatocellular carcinoma HCC, malignant melanoma, and pediatric cancers. The study aims to assess the safety and tolerability of CBA-1205 across five parts, including dose escalation and evaluation in different patient groups where standard treatments are unavailable or ineffective. This trial is conducted at multiple centers and is non-randomized and open-label. Participants receive CBA-1205 intravenously at two-week intervals in 28-day cycles. The study includes seven dose cohorts ranging from 0.1 mgkg to 30 mgkg for solid tumors in Part 1, with subsequent parts focusing on specific cancers such as HCC, melanoma, and pediatric cancers. Treatment continues until criteria for discontinuation are met. Pharmacokinetic analysis is also part of the evaluation. During the study, participants will undergo safety monitoring for dose-limiting toxicities and adverse events up to 12 months. Blood samples will be collected to measure serum drug concentration and immunogenicity. Efficacy assessments occur at screening, during treatment cycles, and until treatment discontinuation. Overall, participant involvement includes regular visits for treatment administration and comprehensive monitoring throughout the study duration.

CONDITIONS

Brief Title

A Phase I, First in Human Study of CBA-1205, Anti-DLK1 Monoclonal Antibody in Patients With Advanced Solid Tumors, Hepatocellular Carcinoma (HCC), Melanoma, and Pediatric Cancer

Who Can Participate

Age: 2Years +

All Genders

Eligibility Criteria

You may qualify if you...

Patients who provide voluntary written informed consent to participate in the study
Patients with an Eastern Cooperative Oncology Group (ECOG) performance status of 641
Patients with preserved renal function as shown by lab data within 7 days before enrollment (creatinine 64 ULN �0d71.5)
Bone marrow function meeting lab criteria within 7 days before enrollment: neutrophil count 641500/bcL, platelet count 6475000/bcL, hemoglobin 649.0 g/dL
Patients with solid tumors without standard therapy or refractory/intolerant to standard therapy (Parts 2 and 3)
Patients with Child-Pugh A or B liver function (Parts 2 and 3)
Patients with malignant melanoma refractory or intolerant to standard therapy (Part 4)
Patients aged 2 to under 20 years (Part 5)
Patients with a Lansky Performance Status 6470 (for those 15 years or younger) or Karnofsky Performance Status 6470 (for those 16 years or older) (Part 5)
Pediatric patients with preserved renal function as shown by lab data within 7 days before enrollment (eGFR 6460 mL/min/1.73 m�b2) (Part 5)
Pediatric patients with cancers without standard therapy or refractory/intolerant to standard therapy (Part 5)

You will not qualify if you...

Patients who had major surgery within 28 days before enrollment
Patients who received anticancer treatment (surgical, radiation, or drug therapy) within 14 days before enrollment
Patients who received immune checkpoint inhibitors or similar treatments within 28 days before enrollment
Patients with Grade 2 or higher concurrent disease or prior therapy-related toxicity
Patients who received any other investigational product within 28 days before enrollment
Patients with current or previous uncontrolled or clinically significant cardiac disease
Patients deemed inappropriate by the investigator or subinvestigator

Research Team

Tanaka Miseri Chiome Bioscience Inc.

General Affairs and Human Resources Department Chiome Bioscience Inc.

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