RECRUITINGPhase 1INTERVENTIONAL
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
A Phase I, First in Human Study of CBA-1205, Anti-DLK1 Monoclonal Antibody in Patients With Advanced Solid Tumors.
About This Trial
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.
Who May Be Eligible (Plain English)
Who May Qualify:(Part 1-4)
- Patients who provide voluntary written willing to sign a consent form 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)
Who May Qualify:(Part 5)
- Patients who provide voluntary written willing to sign a consent form 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 willing to sign a consent form
- 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
Who Should NOT Join This Trial: (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
...See full criteria on ClinicalTrials.gov
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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
Treatments Being Tested
DRUG
CBA-1205 Part 1
CBA-1205: 0.1, 0.3, 1, 3, 10, 20, 30 mg/kg (Intravenous solution)
DRUG
CBA-1205 Part 2
CBA-1205: 20 mg/kg and 30 mg/kg (Intravenous solution)
DRUG
CBA-1205 Part 3
CBA-1205: 30 mg/kg (Intravenous solution)
DRUG
CBA-1205 Part 4
CBA-1205: 20 mg/kg (Intravenous solution)
DRUG
CBA-1205 Part 5
CBA-1205: 10 mg/kg (The initial cohort, Intravenous solution)
Locations (5)
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
University of Yamanashi Hospital
Chūō, Yamanashi, Japan