NCT06046066

A Phase 1 Study of NM6603 in Advanced Solid Tumors

A Phase I Study to Determine the Maximum Tolerated Dose and Evaluate Safety, Tolerability, and Pharmacokinetics of NM6603 in Patients With Advanced Solid Tumors

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: NucMito Pharmaceuticals Co. Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is to assess the MTD and RP2D of NM6603 in adult patients with advanced solid tumors.

Detailed description

This is a Phase 1, first-in-human, multicenter, open label, 3+3 dose escalation study designed to evaluate the safety profile, the maximum tolerated dose (MTD), the recommended Phase 2 dose (RP2D), the pharmacokinetic and the preliminary antitumor activity of NM6603 in patients with advanced solid tumors. The study has two parts. In Part 1, NM6603 will be administered once daily. In Part 2, NM6603 will be administered twice daily to explore the effect of twice daily dosing on the pharmacokinetic, safety and tolerability, and anti-tumor activity profile of NM6603,

Conditions

• Cancers

Interventions

Type	Name	Description
DRUG	NM6603	NM6603 is an orally available investigational small molecule indicated for the treatment of solid malignancies including, but not limited to breast, liver, pancreatic, colorectal, cervical, melanoma and lung cancers.

Timeline

• Start date: 2023-08-31
• Primary completion: 2025-10-31
• Completion: 2026-02-28
• First posted: 2023-09-21
• Last updated: 2025-06-12

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study