RecruitingSolid TumorsHepatocellular Carcinoma (HCC)Malignant Melanoma
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
Eligible age
2+ yrs
Accepts
All genders
Locations
0 states
Healthy volunteers
No
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About this study
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.
Sponsor: Chiome Bioscience Inc.
You may qualify if…
- ✓ 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
You may not qualify if…
- ✕ 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
Source: ClinicalTrials.gov · NCT06636435 · last updated 2026-06-17