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

PHASE1RecruitingINTERVENTIONAL
Enrollment

120

Participants

Timeline

Start Date

October 1, 2021

Primary Completion Date

January 1, 2026

Study Completion Date

September 1, 2026

Conditions
Advanced Solid Tumor
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 ."

Trial Locations (4)

886

NOT_YET_RECRUITING

National Taiwan University Hospital Yunlin Branch, Yunlin

70112

NOT_YET_RECRUITING

LSU-LCMC Health Cancer Center, New Orleans

77030

RECRUITING

The University of Texas MD Anderson Cancer Center, Houston

008866

RECRUITING

National Cheng Kung University Hospital(NCKUH), Tainan

All Listed Sponsors
lead

Ningbo Newbay Technology Development Co., Ltd

INDUSTRY