Source ID: C12
Original URL: https://heidelberg-pharma.com/images/managed/HDP-101-01_IMS_poster.pdf
Source date (attachment preserved): 2026-09-24
Data date (attachment preserved): 2026-09-03
Checked at: 2026-10-07T18:42:25+08:00
Timezone: Asia/Taipei
Retrieval mode: original_web_ref_same_url
Read level: 原 URL 單頁 IMS 2026 海報的 web 工具 PDF 文字；僅必要研究設計、進展及安全性/PK-PD 段，未在本輪核圖像
Access result: 直接 URL 首次工具報 not accessible；原已用 turn62view0 正常回讀同一 URL 單頁 PDF 文字（不是替代 URL）。
Original raw artifact SHA256: null

LOCATORS (actual reading positions):
PDF 第1頁：Design & Methodology L30–35；Study Progress L43–53
PDF 第1頁：Results / Demographics L57–62；PK/PD L83–86；Conclusions L88–91；Data cutoff L128

MINIMUM VERBATIM EXCERPT (only this block is source prose):
175 µg/kg was selected as RP2D, with a split first dose and premedication, followed by Q3W dosing.

EXTRACTED FACTUAL FIELDS (not a reconstructed quotation):
[
  {
    "locator": "p1 L57–59, L128",
    "trial_data_cutoff": "2026-09-03",
    "phase": 1,
    "N_dosed": 53,
    "dose_escalation_cohorts": 10,
    "dose_range": [
      20,
      218
    ],
    "dose_unit": "µg/kg"
  },
  {
    "locator": "p1 Study Progress L44–53",
    "RP2D": 175,
    "unit": "µg/kg",
    "schedule": "首劑分次並預先給藥；之後 Q3W",
    "phase2a_expansion": "已開始收案",
    "premedication_classes": [
      "corticosteroids",
      "antihistamines"
    ],
    "risk_targets": [
      "thrombocytopenia",
      "liver enzyme elevations"
    ]
  },
  {
    "locator": "p1 L85–86",
    "evidence_level": "當時 PK/PD 模型支持首劑分次降低對血小板及肝功能的影響；非隨機獨立比較證實"
  }
]

SCOPE / PRECISE GAP (reviewer description, not source prose):
支持早期 RRMM 劑量/進展與給藥管理；未證明實體癌的 prior Topo-I ADC 療效，也未將模型或單臂資料作確認性治療窗比較。source_date 2026-09-24 按附件保留；本頁直接可核的是 2026-09-03 cutoff。

Web refs: turn116view2, turn118view0, turn133view0, turn133view1