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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-01

Study Completion Date

2026-06-30

Brief Summary

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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.

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Detailed Description

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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

Conditions

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Solid Tumors Hepatocellular Carcinoma (HCC) Malignant Melanoma Pediatric Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

CBA-1205 Part 1

Intervention Type DRUG

CBA-1205: 0.1, 0.3, 1, 3, 10, 20, 30 mg/kg (Intravenous solution)

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.

Group Type EXPERIMENTAL

CBA-1205 Part 2

Intervention Type DRUG

CBA-1205: 20 mg/kg and 30 mg/kg (Intravenous solution)

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.

Group Type EXPERIMENTAL

CBA-1205 Part 3

Intervention Type DRUG

CBA-1205: 30 mg/kg (Intravenous solution)

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.

Group Type EXPERIMENTAL

CBA-1205 Part 4

Intervention Type DRUG

CBA-1205: 20 mg/kg (Intravenous solution)

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.

Group Type EXPERIMENTAL

CBA-1205 Part 5

Intervention Type DRUG

CBA-1205: 10 mg/kg (The initial cohort, Intravenous solution)

Interventions

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CBA-1205 Part 1

CBA-1205: 0.1, 0.3, 1, 3, 10, 20, 30 mg/kg (Intravenous solution)

Intervention Type DRUG

CBA-1205 Part 2

CBA-1205: 20 mg/kg and 30 mg/kg (Intravenous solution)

Intervention Type DRUG

CBA-1205 Part 3

CBA-1205: 30 mg/kg (Intravenous solution)

Intervention Type DRUG

CBA-1205 Part 4

CBA-1205: 20 mg/kg (Intravenous solution)

Intervention Type DRUG

CBA-1205 Part 5

CBA-1205: 10 mg/kg (The initial cohort, Intravenous solution)

Intervention Type DRUG

Eligibility Criteria

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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 (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)

* 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

* 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

Minimum Eligible Age

2 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No