[B026] 临床研究方案与设计

{
  "data": {
    "masking": "None (Open Label)",
    "outcome": [
      {
        "title": "Recommended Phase II Dose (RP2D)",
        "time_frame": "Up to approximately 24 months",
        "description": "The RP2D is defined as the dose level chosen by the sponsor (in consultation with the investigators) for phase II study, based on safety, tolerability, efficacy, PK, and PD data collected during the dose escalation study of BL-B01D1.",
        "outcome_type": "Primary"
      }
    ],
    "allocation": "N/A",
    "enrollment": [
      {
        "location": "Domestic",
        "enrollment": 98,
        "enrollment_text": "国内：150",
        "enrollment_type": "Anticipated"
      }
    ],
    "start_date": {
      "time_ts": 1785542400000,
      "date_type": "Anticipated"
    },
    "study_type": "Interventional",
    "completion_date": {
      "time_ts": 1785542400000,
      "date_type": "Anticipated"
    },
    "primary_purpose": "Treatment",
    "register_number": "NCT06498986",
    "arm_intervention": [
      {
        "intervention": [
          {
            "intervention_name": "BL-B01D1",
            "intervention_type": "Drug",
            "intervention_description": "Administration by intravenous infusion for a cycle of 3 weeks."
          }
        ],
        "design_group_type": "Experimental",
        "design_group_title": "BL-B01D1+Osimertinib Mesylate Tablets",
        "design_group_description": "Participants receive BL-B01D1+Osimertinib Mesylate Tablets in the first cycle (3 weeks). Participants with clinical benefit could receive additional treatment for more cycles. The administration will be terminated because of disease progression or intolerable toxicity occurring or other reasons."
      }
    ],
    "clinical_trial_id": "202425a889e52ae802432a8295220e53",
    "first_posted_date": 1720742400000,
    "intervention_model": "Single Group Assignment",
    "primary_completion_date": {
      "time_ts": 1785542400000,
      "date_type": "Anticipated"
    }
  },
  "status": true,
  "error_code": 0
}