OncoMatch/Clinical Trials/NCT06636435
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
Is NCT06636435 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments for solid tumors.
Treatment: CBA-1205 Part 1 · CBA-1205 Part 2 · CBA-1205 Part 3 · CBA-1205 Part 4 · CBA-1205 Part 5 — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Tumor Agnostic
Hepatocellular Carcinoma
Melanoma
Performance status
ECOG/LANSKY/KARNOFSKY 0–1
ECOG performance status (PS) of ≤1 (adults); 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)
Prior therapy
Cannot have received: anticancer treatment (surgical therapy, radiation therapy, and/or drug therapy)
Patients who have received anticancer treatment with surgical therapy, radiation therapy, and/or drug therapy within 14 days before enrollment
Cannot have received: immune checkpoint inhibitor
Patients who have received anticancer treatment with immune checkpoint inhibitor, etc. within 28 days before enrollment
Cannot have received: investigational product
Patients who have received any other investigational product within 28 days before enrollment
Lab requirements
Blood counts
Neutrophil count ≥1500/μL, Platelet count ≥75000/μL, Hemoglobin ≥9.0 g/dL
Kidney function
creatinine: ≤ ULN ×1.5 (adults); eGFR ≥60 mL/min/1.73 m² (pediatrics)
Patients with preserved renal function as evidenced by laboratory data obtained within 7 days before enrollment (creatinine: ≤ ULN ×1.5); eGFR ≥60 mL/min/1.73 m² (pediatrics); Neutrophil count ≥1500/μL, Platelet count ≥75000/μL, Hemoglobin ≥9.0 g/dL; Child-Pugh A or B (for HCC patients)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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