NCT03466268

Study to Evaluate the Safety and Anti-tumor Activity of SCC244

A Phase I Trial to Assess the Safety, Pharmacokinetics, and Anti-tumor Activity of SCC244 in Subjects With Advanced Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: Haihe Biopharma Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study evaluates the Safety, Tolerability, Pharmacokinetics, and Anti-tumor Activity of SCC244 in patients with advanced solid tumors with c-Met Alterations.

Detailed description

A Phase I Dose Escalation and Dose Expansion Trial to Evaluate the Safety, Pharmacokinetics and Anti-tumor Activity of SCC244, a Highly Selective c-Met Inhibitor, in Patients with Advanced Non-small Cell Lung Cancer. Phase Ia: The primary objective is to determine the MTD, BED and recommended dose for Phase Ib in patients with advanced NSCLCs. In addition, the safety, tolerability, preliminary efficacy and PK of SCC244 and its metabolites will also be evaluated. In phase Ia, planned dose levels will be evaluated with a starting dose of 100mg. Phase Ib: The primary objective is to assess the ORR in advanced NSCLC patients with c-MET change. The DOR, DCR, TTR, PFS, one-year OS rate, safety, tolerability, and PK will also be evaluation in Phase Ib.

Conditions

• Advanced Solid Tumor

Interventions

Type	Name	Description
DRUG	Gumarontinib Tablets	Either at 100mgSD、100mgQD、200mgSD、200mgQD、400mgSD、400mgQD、300mgBID、400mgBID

Timeline

• Start date: 2017-09-14
• Primary completion: 2023-01-09
• Completion: 2023-01-09
• First posted: 2018-03-15
• Last updated: 2024-10-09

Locations

1 site across 1 country: China