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

Summary

In this first-in-human, muticenter, non-randomized, open-label, standard 3+3 dose escalation Phase I study encompasses 5 parts (Part 1-5). The purpose of this FIH study is to evaluate the safety and tolerability profile of CBA-1205.

Eligibility

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

Conditions7

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