Spots Global Cancer Trial Database for A Phase 1 Study of NM6603 in Advanced Solid Tumors
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Trial Identification
Brief Title: A Phase 1 Study of NM6603 in Advanced Solid Tumors
Official Title: A Phase I Study to Determine the Maximum Tolerated Dose and Evaluate Safety, Tolerability, and Pharmacokinetics of NM6603 in Patients With Advanced Solid Tumors
Study ID: NCT06046066
Conditions
Interventions
Study Description
Brief 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,
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Karmanos Cancer Institute, Detroit, Michigan, United States
Cleveland Clinic Taussig Cancer Center, Cleveland, Ohio, United States
Tennessee Oncology, PLLC, Nashville, Tennessee, United States
MD Anderson Cancer Center, Houston, Texas, United States
Contact Details
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