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Trial Title:
A Phase I, First in Human Study of CBA-1205, Anti-DLK1 Monoclonal Antibody in Patients with Advanced Solid Tumors and Hepatocellular Carcinoma (HCC)
NCT ID:
NCT06636435
Condition:
Hepatocellular Carcinoma (HCC)
Solid Tumors
Conditions: Official terms:
Carcinoma
Carcinoma, Hepatocellular
Conditions: Keywords:
DLK1
First in human
Phase I
Antibody
solid tumor
Hepatocellular Carcinoma
CBA-1205
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
CBA-1205
Description:
CBA-1205: 0.1, 0.3, 1, 3, 10, 20, 30 mg/kg (Intravenous solution)
Arm group label:
CBA-1205: Part 1
Intervention type:
Drug
Intervention name:
CBA-1205
Description:
CBA-1205 : 20 mg/kg and 30 mg/kg (Intravenous solution)
Arm group label:
CBA-1205: Part 2
Intervention type:
Drug
Intervention name:
CBA-1205
Description:
CBA-1205: 30 mg/kg (Intravenous solution)
Arm group label:
CBA-1205: Part 3
Summary:
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.
Detailed 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
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
20 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
National Cancer Center Hospital East
Address:
City:
Kashiwa
Country:
Japan
Status:
Recruiting
Facility:
Name:
Kanagawa Cancer Center
Address:
City:
Yokohama
Country:
Japan
Status:
Recruiting
Facility:
Name:
National Cancer Center Hospital
Address:
City:
Chuo
Country:
Japan
Status:
Recruiting
Facility:
Name:
Niigata University Medical and Dental Hospital
Address:
City:
Niigata
Country:
Japan
Status:
Recruiting
Start date:
June 1, 2020
Completion date:
June 30, 2025
Lead sponsor:
Agency:
Chiome Bioscience Inc.
Agency class:
Industry
Source:
Chiome Bioscience Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06636435
https://www.chiome.co.jp/
