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

Chiome Bioscience Inc.

Status and phase: Enrolling; Phase 1

Conditions: Solid Tumors; Hepatocellular Carcinoma (HCC)

Treatments: Drug: CBA-1205

Study type: Interventional

Funder types: Industry

Identifiers

NCT06636435

1205-001

jRCT2080225288 (Other Identifier)

Details and patient eligibility

About

In this first-in-human, multicenter,non-randomized, open-label, standard 3+3 dose escalation Phase I study encompasses 3parts(Part1-3). 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 three parts in a stepwise manner:

• 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.
• 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.
• 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.
• PK analysis

Enrollment: 50 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

---

50 participants in 3 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) for solid tumor. In the study treatment period, CBA-1205 is intravenously administered at 2-week intervals in a 28-day cycle.

Treatment:

Drug: CBA-1205

Drug: CBA-1205

Drug: CBA-1205

CBA-1205: Part 2

Experimental group

Description:

CBA-1205 (20, 30 mg/kg) injection is administered at 2-week intervals in 28-day cycles for HCC patients. In the study treatment period, the study drug is administered at 2-week intervals.

Treatment:

Drug: CBA-1205

Drug: CBA-1205

Drug: CBA-1205

CBA-1205: Part 3

Experimental group

Description:

CBA-1205 (30 mg/kg) injection is administered at 2-week intervals in 28-day cycles for HCC patients. In the study treatment period, the study drug is administered at 2-week intervals.

Treatment:

Drug: CBA-1205

Drug: CBA-1205

Drug: CBA-1205