NCT05429762

Effect of Tusamitamab Ravtansine on QTc Interval in Participants With Metastatic Solid Tumors

Open-label Study Evaluating the Effect of Tusamitamab Ravtansine on the QTc Interval in Participants With Metastatic Solid Tumors

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase1, single-arm study for treatment. This is a prospective multicenter, multinational, open-label study to assess the effect of tusamitamab ravtansine on the QT interval in participants with metastatic colorectal cancer (CRC), nonsquamous non small cell lung cancer (NSQ NSCLC), or gastric/ gastroesophageal junction (GEJ) adenocarcinoma for which in the judgement of the Investigator, no standard alternative therapy is available.

Detailed description

This is a single arm study in which participants will receive treatment with tusamitamab ravtansine until disease progression, unacceptable toxicity, the start of a new anti-cancer therapy, or the participant's or Investigator's decision to stop the treatment, whichever comes first.

Conditions

• Neoplasm

Interventions

Type	Name	Description
DRUG	Tusamitamab ravtansine	Pharmaceutical form: Concentrated solution for intravenous (IV) administration; Route of administration: IV infusion

Timeline

• Start date: 2022-10-03
• Primary completion: 2023-08-01
• Completion: 2024-04-10
• First posted: 2022-06-23
• Last updated: 2025-04-06

Locations

7 sites across 5 countries: United States, Belgium, France, Spain, Turkey (Türkiye)

Regulatory

• FDA-regulated drug study