Tusamitamab Ravtansine in Patients with Advanced Solid Tumors: Phase I Study of Safety, Pharmacokinetics, and Antitumor Activity Using Alternative Dosing Regimens.

ABSTRACT:

Purpose

Tusamitamab ravtansine is an antibody-drug conjugate that targets carcinoembryonic antigen-related cell adhesion molecule 5 (CEACAM5) and delivers a cytotoxic maytansinoid payload. In a phase I dose-escalation study, the maximum tolerated dose (MTD) was 100 mg/m² every 2 weeks (Q2W). Here we report results for two alternative schedules.

Experimental design

Adults ages ≥18 years (range, 34-73) with locally advanced/metastatic solid tumors (N = 43; colon/rectum, 29; stomach, 7; pancreas, 4; other, 3) expressing/likely to express CEACAM5 received intravenous tusamitamab ravtansine 120-170 mg/m² [loading dose (LD)], then 100 mg/m² Q2W (Q2W-LD, n = 28), or 120-190 mg/m² fixed dose [every 3 weeks (Q3W), n = 1

SUBMITTER: Tabernero J 

PROVIDER: S-EPMC10461573 | biostudies-literature | 2023 Aug

REPOSITORIES: biostudies-literature