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 (Jun 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
Treatments studied
Other
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)
Demographics
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.
Frequently asked questions
Is NCT06636435 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior anticancer treatment (surgical therapy, radiation therapy, and/or drug therapy), immune checkpoint inhibitor, investigational product disqualifies patients from enrollment.
Is there an age limit?
Yes. Patients must be 19 years or younger and at least 2 years old.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages