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RECRUITING
NCT05036291
PHASE1

A Study of NB004 as Monotherapy or Combination Therapy in Patients With Advanced Solid Tumors

Sponsor: Ningbo Newbay Technology Development Co., Ltd

View on ClinicalTrials.gov

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

Interventions

DRUG

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