Scholarlink

Background <p>Tusamitamab ravtansine (SAR408701) is an immunoconjugate that binds carcinoembryonic antigen-related cell adhesion molecule 5 (CEACAM5) and delivers its cytotoxic payload to target cells. Here, we report findings from three dosing regimens of tusamitamab ravtansine administration in Japanese adults with advanced malignant solid tumors.</p> Methods <p>Japanese adults (aged ≥ 20&#xa0;years) with CEACAM5-expressing malignant solid tumors were enrolled in this Phase 1, open-label, non-randomized, dose-escalation evaluation of tusamitamab ravtansine in three parts: (i) main dose-escalation part with every two weeks (Q2W) administration, (ii) loading dose (LD) part with Q2W administration with a LD at Cycle 1 (C1) only, and (iii) dose-escalation every three weeks (Q3W) part. Primary objectives were to evaluate the tolerability and safety of tusamitamab ravtansine.</p> Results <p>Nine patients were enrolled in the main dose-escalation part, 16 patients in the dose-escalation <i>bis</i> part with LD, and nine patients in the dose-escalation Q3W part. Administration of tusamitamab ravtansine resulted in a manageable safety profile with no dose-limiting toxicities reported during the observation period except for two events during dose-escalation <i>bis</i> Q2W part. Most common adverse events (AEs) were corneal events, gastrointestinal disorders, and metabolic events. After first administration, tusamitamab ravtansine exposure was dose proportional over the dose range 80–170&#xa0;mg/m<sup>2</sup>. Best overall response (BOR) was stable disease, observed in all three parts; confirmed response was not observed at any dose level.</p> Conclusion <p>Tusamitamab ravtansine demonstrated a tolerable safety profile at a dose of 80–170&#xa0;mg/m<sup>2</sup> in three different administration schedules in Japanese adults with metastatic solid tumors.</p>

错误：搜索内容不能为空，请输入英文关键词
错误：关键词超出字数限制，请精简
高级检索

Phase 1 study evaluating safety and pharmacokinetics of tusamitamab ravtansine monotherapy in Japanese patients with advanced malignant solid tumors

  • 期刊论文

  • 出版模式：

    开放获取

  • 发表日期：

    2025年5月25日

查看全文
  • Kei Muro,
  • Kentaro Yamazaki,
  • Shigenori Kadowaki,
  • Saori Mishima,
  • Takeshi Kawakami,
  • Tomoyuki Tanaka,
  • Keisuke Tada,
  • Nathalie Fagniez,
  • Shinobu Ohshima,
  • Takayuki Yoshino

摘要

Background

Tusamitamab ravtansine (SAR408701) is an immunoconjugate that binds carcinoembryonic antigen-related cell adhesion molecule 5 (CEACAM5) and delivers its cytotoxic payload to target cells. Here, we report findings from three dosing regimens of tusamitamab ravtansine administration in Japanese adults with advanced malignant solid tumors.

Methods

Japanese adults (aged ≥ 20 years) with CEACAM5-expressing malignant solid tumors were enrolled in this Phase 1, open-label, non-randomized, dose-escalation evaluation of tusamitamab ravtansine in three parts: (i) main dose-escalation part with every two weeks (Q2W) administration, (ii) loading dose (LD) part with Q2W administration with a LD at Cycle 1 (C1) only, and (iii) dose-escalation every three weeks (Q3W) part. Primary objectives were to evaluate the tolerability and safety of tusamitamab ravtansine.

Results

Nine patients were enrolled in the main dose-escalation part, 16 patients in the dose-escalation bis part with LD, and nine patients in the dose-escalation Q3W part. Administration of tusamitamab ravtansine resulted in a manageable safety profile with no dose-limiting toxicities reported during the observation period except for two events during dose-escalation bis Q2W part. Most common adverse events (AEs) were corneal events, gastrointestinal disorders, and metabolic events. After first administration, tusamitamab ravtansine exposure was dose proportional over the dose range 80–170 mg/m2. Best overall response (BOR) was stable disease, observed in all three parts; confirmed response was not observed at any dose level.

Conclusion

Tusamitamab ravtansine demonstrated a tolerable safety profile at a dose of 80–170 mg/m2 in three different administration schedules in Japanese adults with metastatic solid tumors.