Trial of ZN-A-1041 Enteric Capsules in Patients With HER2-Positive Advanced Solid Tumors

PHASE1CompletedINTERVENTIONAL
Enrollment

61

Participants

Timeline

Start Date

October 15, 2020

Primary Completion Date

April 16, 2024

Study Completion Date

April 16, 2025

Conditions
Advanced Solid TumorsHER2-positive Breast Cancer
Interventions
DRUG

ZN-A-1041 50mg BID

Orally 21days for one cycle

DRUG

ZN-A-1041 100mg BID

Orally 21days for one cycle

DRUG

ZN-A-1041 200mg BID

Orally 21days for one cycle

DRUG

ZN-A-1041 400mg BID

Orally 21days for one cycle

DRUG

ZN-A-1041 600mg BID

Orally 21days for one cycle

DRUG

ZN-A-1041 800mg BID

Orally 21days for one cycle

DRUG

ZN-A-1041 1000mg BID

Orally 21days for one cycle

DRUG

ZN-A-1041 Level 1 +Capecitabine 1000 mg/m2 + Trastuzumab 8 mg/kg iv. First Cycle

ZN-A-1041 level 1 BID; Capecitabine 1000 mg/m2 BID Trastuzumab 8 mg/kg iv. First Cycle

DRUG

ZN-A-1041 Level 2 +Capecitabine 1000 mg/m2 + Trastuzumab 8 mg/kg iv. First Cycle

ZN-A-1041 level 2 BID; Capecitabine 1000 mg/m2 BID Trastuzumab 8 mg/kg iv. First Cycle

DRUG

ZN-A-1041 MAD +Capecitabine 1000 mg/m2 + Trastuzumab 8 mg/kg iv. First Cycle

ZN-A-1041 MAD BID; Capecitabine 1000 mg/m2 BID Trastuzumab 8 mg/kg iv. First Cycle

DRUG

ZN-A-1041+Capecitabine + Trastuzumab 8 mg/kg iv. First Cycle

Base on 1b ZN-A-1041 dose Base on 1b Capecitabine dose Base on 1b Trastuzumab dose

Trial Locations (1)

100000

Cancer hospital Chinese academy of medical sciences, Beijing

All Listed Sponsors
lead

Suzhou Zanrong Pharma Limited

INDUSTRY

NCT04487236 - Trial of ZN-A-1041 Enteric Capsules in Patients With HER2-Positive Advanced Solid Tumors | Biotech Hunter | Biotech Hunter