Clinical trial · Interventional
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.
NCT06636435CI-TRIAL-00115083recruitingPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hepatocellular Carcinoma (HCC) | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.85 |
| Malignant Melanoma | Melanoma | ALIAS | 0.90 |
| Pediatric Cancer | Childhood Malignant Neoplasm | ALIAS | 0.90 |
| Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CBA-1205 Part 1 | Drug | — | UNRESOLVED |
| CBA-1205 Part 2 | Drug | — | UNRESOLVED |
| CBA-1205 Part 3 | Drug | — | UNRESOLVED |
| CBA-1205 Part 4 | Drug | — | UNRESOLVED |
| CBA-1205 Part 5 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (5)
- type
- EXPERIMENTAL
- label
- CBA-1205: Part 1
- description
- 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.
- interventionNames
- Drug: CBA-1205 Part 1
- type
- EXPERIMENTAL
- label
- CBA-1205: Part 2
- description
- 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.
- interventionNames
- Drug: CBA-1205 Part 2
- type
- EXPERIMENTAL
- label
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 2 Years
Show eligibility criteria text
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
References
Publications (2)
- BACKGROUNDNakamura K, Takahashi K, Sakaguchi I, Satoh T, Zhang L, Yanai H, Tsukumo Y. A Novel Glycoengineered Humanized Antibody Targeting DLK1 Exhibits Potent Anti-Tumor Activity in DLK1-Expressing Liver Cancer Cell Xenograft Models. Int J Mol Sci. 2024 Dec 19;25(24):13627. doi: 10.3390/ijms252413627. PMID 39769389
- RESULTKatsuya Y, Ikeda M, Koyama T, Sato J, Okada M, Matsubara N, Kondoh C, Mukohara T, Watanabe K, Kotani D, Ogawa Y, Taoka S, Yamamoto N. A Phase I, First-In-Human Study of CBA-1205, an Anti-DLK1 Monoclonal Antibody, in Patients With Advanced Solid Tumors. Cancer Sci. 2025 Apr;116(4):1012-1022. doi: 10.1111/cas.16454. Epub 2025 Jan 20. PMID 39832211