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

Phase 1

Recruiting

• Conditions: Solid Tumors; Pediatric Cancer; Hepatocellular Carcinoma (HCC); Malignant Melanoma
• Interventions: Drug: CBA-1205 Part 1; Drug: CBA-1205 Part 2; Drug: CBA-1205 Part 3; Drug: CBA-1205 Part 4; Drug: CBA-1205 Part 5

• Registration Number: NCT06636435
• Lead Sponsor: Chiome Bioscience Inc.

Brief 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.

Detailed Description

To evaluate safety and efficacy of CBA-1205 in the following five parts in a stepwise manner:

Part 1

* In Part 1, safety and tolerability in patients with Solid Tumor where no standard treatment is available, or who are intolerable or non-responder to the standard treatment will be evaluated. Initial dose for Part 2 will be determined.

Part 2

* In Part 2, safety and tolerability in patients with advanced and/or recurrent Hepatocellular Carcinoma which are unresectable, or who are intolerable or non-responder to the standard treatment will be evaluated. Recommended dose in this population will be determined.

Part 3

* In Part 3, safety and efficacy at the recommended dose in patients with advanced and/or recurrent Hepatocellular Carcinoma which are unresectable, or who are intolerable or non-responder to the standard treatment will be evaluated.

Part 4

* In Part 4, safety and efficacy in patients with Malignant Melanoma who are refractory or intolerant to standard therapy.

Part 5

* In Part 5, safety, tolerability and the recommended dose of the study drug in patients with Pediatric Cancer where no standard treatment is available, or who are intolerable or non-responder to the standard treatment will be evaluated.

PK analysis

Study Timeline

• Study Start: 2020-06-01
• Study First Submitted: 2024-09-30
• Study First Submitted QC: 2024-10-09
• Study First Posted: 2024-10-10
• Status Verified: 2025-09
• Last Update Submitted: 2025-09-15
• Last Update Posted: 2025-09-19
• Primary Completion: 2026-06-30
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 66

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
CBA-1205: Part 1	CBA-1205 Part 1	CBA-1205 injection is administered at 2-week intervals in seven cohorts (0.1, 0.3, 1, 3, 10, 20, 30 mg/kg) in patients with solid tumor. Note: In the study treatment period, CBA-1205 is intravenously administered at 2-week intervals in a 28-day cycle.
CBA-1205: Part 2	CBA-1205 Part 2	CBA-1205 (20, 30 mg/kg) injection is administered at 2-week intervals in 28-day cycles in patients with HCC . Note: The study drug is administered at 2-week intervals until any of the criteria for discontinuation of study treatment are met.
CBA-1205: Part 3	CBA-1205 Part 3	CBA-1205 injection is administered at 2-week intervals in 28-day cycles in patients with HCC. Note: The study drug is administered at 2-week intervals until any of the criteria for discontinuation of study treatment are met.
CBA-1205 : Part 4	CBA-1205 Part 4	CBA-1205 injection is administered at 2-week intervals in 28-day cycles in patients with Malignant Melanoma. Note: The study drug is administered at 2-week intervals until any of the criteria for discontinuation of study treatment are met.
CBA-1205: Part 5	CBA-1205 Part 5	CBA-1205 injection is administered at 2-week intervals in 28-day cycles in patients with Pediatric Cancer. Note: The study drug is administered at 2-week intervals until any of the criteria for discontinuation of study treatment are met.

Primary Outcome Measures

Name	Time	Method
Dose limiting toxicity	Part 1, 2 and 5 - Dose limiting toxicity : For 28 days after the first dose of study treatment	DLTs are assessed according to CTCAE v.5.0 during the first cycle (28 days).
Adverse Event	Adverse event : Maximum 12 months	An adverse event is any untoward or unintended sign, symptom, or disease in a subject administered an investigational product, whether or not it is related to the investigational product

Secondary Outcome Measures

Name	Time	Method
Serum CBA-1205 concentration	From Day 1 to Day 43 (or until Discontiuation of treatment)	Blood samples are collected to assess the serum concentration of CBA-1205.
Immunogenicity	From Day1 to Day 43 (or until Discontiuation of treatment)	Blood samples are collected to assess the serum anti-CBA-1205 antibody.
Efficacy	Screening, Day 1 of Cycle 2 and 3, and Day 1 of even-numbered cycles from Cycle 4 onward until treatment discontinuation. Maximum 12 months	Antitumor response evaluated in accordance with the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1; Tumor markers

Trial Locations

Locations (5)

University of Yamanashi Hospital; 🇯🇵 Chūō, Yamanashi, Japan

National Cancer Center Hospital East; 🇯🇵 Kashiwa, Chiba, Japan

Kanagawa Cancer Center; 🇯🇵 Yokohama, Kanagawa, Japan

Niigata University Medical and Dental Hospital; 🇯🇵 Niigata, Niigata, Japan

National Cancer Center Hospital; 🇯🇵 Chūō, Tokyo, Japan