Solid Tumors study: CBA-1205 Part
Official title 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
ClinicalTrials.gov ID: NCT06636435
What this study is testing
What is CBA-1205?
CBA-1205 is an investigational medicine being studied as a potential treatment for solid tumors.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study aims to find the safest dose of the new drug and check for any side effects.
- Who it's for
- The study is looking for people with advanced solid tumors, liver cancer, melanoma, or pediatric cancer.
- What's involved
- Participants will receive the new drug and undergo regular medical tests to monitor their health and safety.
- Time commitment
- The study involves multiple visits to monitor safety, but the total duration is not specified in the provided text.
- Phase 1: an early, usually small safety study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 2 and older
You may be able to join if
- (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...
You likely can't join if
- (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
See the full eligibility 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
- 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) (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
- (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
The study team makes the final eligibility decision.
Where it is enrolling
- Kashiwa, Chiba, Japan
- Yokohama, Kanagawa, Japan
- Niigata, Niigata, Japan
- Chūō, Tokyo, Japan
- Chūō, Yamanashi, Japan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 2 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Kashiwa, Chiba, Japan; Yokohama, Kanagawa, Japan; Niigata, Niigata, Japan; Chūō, Tokyo, Japan; Chūō, Yamanashi, Japan. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.