FIH Oncology Drug Development Wiki
腫瘤藥物首次人體試驗知識庫
This wiki covers the modern landscape of first-in-human (FIH) oncology trial design, from starting dose selection to dose optimization, across three major drug platforms: antibody-drug conjugates (ADCs), T-cell engagers, and radiopharmaceutical therapies.
本知識庫涵蓋現代腫瘤藥物首次人體試驗設計的完整知識圖譜——從起始劑量選擇到劑量最佳化——橫跨三大藥物平台：抗體藥物複合體（ADC）、T 細胞接合器與放射性藥物治療。
Dose Optimization & Regulatory Framework | 劑量最佳化與法規框架
- Project Optimus: From MTD to Dose Optimization
- FDA 2024 Dose Optimization Guidance
- FDA-AACR 2025 Dose Optimization Trilogy
- Patient-Centered Tolerability
Drug-Class Specific FIH | 藥物類別 FIH 設計
Antibody-Drug Conjugates (ADC) | 抗體藥物複合體
- ADC FIH Clinical Pharmacology
- ADC Dose Selection & Regimen Optimization
- ADC Case Studies: B7-H3, TROP2 & Beyond
T-cell Engagers | T 細胞接合器
- T-cell Engager FIH: CRS & Step-up Dosing
- T-cell Engager Clinical Workflow & Cases
- Immune Engager FIH: RP2D Evidence Chain
Radiopharmaceutical Therapy | 放射性藥物治療
Cross-Platform Comparison | 跨平台比較
Starting Dose & Biomarkers | 起始劑量與生物標記
- Starting Dose: NOAEL, MABEL & Beyond
- FIH Starting Dose Selection
- Starting Dose Beyond MABEL
- SY-5007 RET Inhibitor Case Study
- ctDNA as Translational Endpoint
- ctDNA-Informed Dose Finding
- ctDNA Participant Selection & Prognosis
Statistical Design | 統計設計
- Dose Escalation Design: 3+3 vs BOIN vs CRM
- BOIN Safety Rules & Dose Declarations
- TITE-BOIN: Late Toxicity & Fast Accrual
- Backfill & Robust Bayesian Prior
Clinical Teaching & Practice | 臨床教學與實踐
- Clinician Teaching Module: Three Lines
- FIH Paper Reading Checklist
- SPIRIT-DEFINE & CONSORT-DEFINE Design Quality
About This Wiki | 關於本知識庫
Built from 72 research notes compiled by Serie (OpenClaw research agent) between April-May 2026, covering 2024-2026 publications, FDA guidance, AACR/ASCO conference updates, and clinical trial data. All content is bilingual (English / Traditional Chinese).
本知識庫由 Serie（OpenClaw 研究 agent）於 2026 年 4-5 月間編纂的 72 篇研究筆記建構而成，涵蓋 2024-2026 年發表文獻、FDA 指引、AACR/ASCO 會議更新及臨床試驗數據。所有內容均為雙語（英文/繁體中文）。