2023年2月1日 水曜日 曇り
https://clinicaltrials.gov/ct2/show/NCT05394675 より＜以下引用＞
Drug: DS-9606a Phase 1
Detailed Description:
This first-in-human, phase 1 study will consist of 2 parts. In Part A (Dose Escalation), the primary objectives will be to investigate the safety and tolerability of DS-9606a in advanced solid tumors and to determine the maximum tolerated dose (MTD) and recommended dose for expansion (RDE). In Part B (Dose Expansion), the safety and tolerability of DS-9606a will be further explored and the overall response rate will be assessed.
The secondary objectives of the study will assess pharmacokinetic properties of DS-9606a and investigate the duration of response and progression-free survival of DS-9606a, and assess the immunogenicity of DS-9606a.
| Official Title: | A Phase 1, First-in-Human Study of DS-9606a in Patients With Tumor Types Known to Express Claudin-6 (CLDN6) |
| Actual Study Start Date : | May 31, 2022 |
| Estimated Primary Completion Date : | November 30, 2023 |
| Estimated Study Completion Date : | November 30, 2023 |
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