NCT04689100

Efficacy and Safety of JMT101 in Patients With Advanced Solid Tumor

A Phase I, Open Label, Multi-center Study to Assess the Efficacy and Safety of JMT101 in Patients With Advanced Solid Tumor.

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 259 (estimated)
• Sponsor: Shanghai JMT-Bio Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study is a Phase I, open label, multi-center study of to evaluate the safety and efficacy of JMT101 in patients with advanced solid tumor.

Detailed description

The objective of the trial is to evaluate the safety and efficacy of JMT101 in patients with advanced solid tumor. This study consists of two parts (Stage I and Stage II). Stage I was a dose escalation study, and Stage II was a dose expansion study.

Conditions

• Advanced Solid Tumor

Interventions

Type	Name	Description
DRUG	JMT101	Monotherapy: Accelerated titration method, IV infusion QW; Conventional 3 + 3 study design, IV infusion Q2W. (28-day cycles) Combined with chemotherapy: Conventional 3 + 3 study design, IV infusion Q2W. (28-day cycles)
DRUG	JMT101	IV infusion Q2W (28-day cycles)

Timeline

• Start date: 2017-04-11
• Primary completion: 2021-12-31
• Completion: 2022-06-30
• First posted: 2020-12-30
• Last updated: 2020-12-30

Locations

9 sites across 1 country: China