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

Launched by CHIOME BIOSCIENCE INC. · Oct 9, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called CBA-1205, which is an experimental drug designed to target certain types of cancer, specifically advanced solid tumors and hepatocellular carcinoma (HCC), a type of liver cancer. This is the first time this drug is being tested in humans, and the main goal is to see how safe it is and how well patients tolerate it. The trial is open to adult patients who have solid tumors that don’t have effective standard treatments available or who can’t tolerate those treatments.

To be eligible for this trial, patients need to meet several criteria, such as being able to walk without assistance, having stable kidney function, and having certain blood counts within a specified range. Participants will be monitored closely throughout the study to ensure their safety and to assess how the drug affects their cancer. It's important to note that this trial is currently recruiting participants, meaning that those who qualify can join the study and potentially help in the development of new cancer treatments.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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
• • Patients with unresectable advanced/recurrent hepatocellular carcinoma refractory or intolerable to standard therapy (Part2, 3: HCC)
• • Patients with Child-Pugh A or B (Part2, 3; HCC)
• Exclusion criteria:
• • 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