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

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.

Trial Details

NCT ID
NCT06636435
Phase
PHASE1
Sponsor
Chiome Bioscience Inc.
Status
RECRUITING
Cancer Type
Melanoma
Interventions
  • CBA-1205 Part 1
  • CBA-1205 Part 2
  • CBA-1205 Part 3
  • CBA-1205 Part 4
  • CBA-1205 Part 5
Locations (sample)
  • Kashiwa, Chiba, Japan|35.86224,139.97732
  • Yokohama, Kanagawa, Japan|35.43333,139.65
  • Niigata, Niigata, Japan|37.92259,139.04125
  • Chūō, Tokyo, Japan|35.67004,139.77544
  • Chūō, Yamanashi, Japan|35.59465,138.50275

Key Eligibility Criteria

  • 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 enrollmen…

For full eligibility, visit ClinicalTrials.gov.

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