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

Chiome Bioscience Inc.

Status and phase: Enrolling; Phase 1

Conditions: Malignant Melanoma; Pediatric Cancer; Solid Tumors; Hepatocellular Carcinoma (HCC)

Treatments: Drug: CBA-1205 Part 2; Drug: CBA-1205 Part 5; Drug: CBA-1205 Part 4; Drug: CBA-1205 Part 3; Drug: CBA-1205 Part 1

Study type: Interventional

Funder types: Industry

Identifiers

NCT06636435

1205-001

jRCT2080225288 (Other Identifier)

Details and patient eligibility

About

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.

Full 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

Enrollment: 66 estimated patients

Sex: All

Ages: 2+ years old

Volunteers: No Healthy Volunteers

Inclusion and 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: Single Blind

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66 participants in 5 patient groups

CBA-1205: Part 1

Experimental group

Description:

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.

Treatment:

Drug: CBA-1205 Part 1

CBA-1205: Part 2

Experimental group

Description:

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.

Treatment:

Drug: CBA-1205 Part 2

CBA-1205: Part 3

Experimental group

Description:

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.

Treatment:

Drug: CBA-1205 Part 3

CBA-1205 : Part 4

Experimental group

Description:

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.

Treatment:

Drug: CBA-1205 Part 4

CBA-1205: Part 5

Experimental group

Description:

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.

Treatment:

Drug: CBA-1205 Part 5