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A Study of NB004 as Monotherapy or Combination Therapy in Patients With Advanced Solid Tumors
Sponsor: Ningbo Newbay Technology Development Co., Ltd
Summary
This is a Phase 1, Open-label, Multicenter Study to Assess the Safety, Tolerability, and Pharmacokinetics of NB004 Administered as Monotherapy or Combination Therapy in Subjects with Advanced Solid Tumors
Official title: A Phase 1, Open-label, Multicenter Study to Assess the Safety, Tolerability, and Pharmacokinetics of NB004 Administered as Monotherapy or Combination Therapy in Subjects With Advanced Solid Tumors
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
120
Start Date
2021-10-01
Completion Date
2026-09-01
Last Updated
2025-03-05
Healthy Volunteers
No
Conditions
Interventions
NB004 tablets
Part1: Dose escalation phase of study drug NB004 monotherapy: Drug: NB004 tablets NB004 tablets will be administered orally once daily for repeated 28-day cycles until discontinuation criteria are met. Part 2: Dose Escalation Phase/ COMBO Dose Expansion Phase for the NB004 in combination with Sotorasib: Drug: NB004 tablets \& Sotorasib NB004 tablets will be administered orally once a daily for repeated 21-day cycles until discontinuation criteria are met. Sotorasib will be administered with the recommended dosage per prescribing information approved by the FDA Part 3: Dose Escalation Phase/ COMBO Dose Expansion Phase for the NB004 in combination with Sotorasib: Drug: NB004 tablets \& Sotorasib NB004 tablets will be administered orally once daily for repeated 21-day cycles until discontinuation criteria are met. Sotorasib will be administered with the recommended dosage per prescribing information approved by the FDA .
Locations (4)
LSU-LCMC Health Cancer Center
New Orleans, Louisiana, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States
National Cheng Kung University Hospital(NCKUH)
Tainan, Taiwan, China
National Taiwan University Hospital Yunlin Branch
Yunlin, Taiwan, China