Phase I/Ib Multiple Ascending Dose Study in China

PHASE1CompletedINTERVENTIONAL
Enrollment

24

Participants

Timeline

Start Date

April 24, 2018

Primary Completion Date

July 29, 2019

Study Completion Date

February 8, 2021

Conditions
Metastatic Solid Tumors
Interventions
DRUG

Avelumab 3 mg/kg Q2W

Participants received intravenous infusion of Avelumab over 1 hour duration at a dose of 3 milligrams per kilogram (mg/kg) once every 2 weeks (Q2W) until disease progression, significant clinical deterioration, unacceptable toxicity, or any criterion for withdrawal from the study or from Avelumab occurs.

DRUG

Avelumab 10 mg/kg Q2W

Participants received intravenous infusion of Avelumab over 1 hour duration at a dose of 10 mg/kg Q2W until disease progression, significant clinical deterioration, unacceptable toxicity, or any criterion for withdrawal from the study or from Avelumab occurs.

DRUG

Avelumab 20 mg/kg Q2W

Participants received intravenous infusion of Avelumab over 1 hour duration at a dose of 20 mg/kg Q2W until disease progression, significant clinical deterioration, unacceptable toxicity, or any criterion for withdrawal from the study or from Avelumab occurs.

DRUG

Avelumab 10 mg/kg QW

Participants received intravenous infusion of Avelumab over 1 hour duration at a dose of 10 mg/kg every week (QW) for the first 12 weeks followed by once every 2 weeks, started at Week 13 until disease progression, significant clinical deterioration, unacceptable toxicity, or any criterion for withdrawal from the study or from Avelumab occurs.

Trial Locations (3)

Unknown

Research site, Guangzhou

Research site, Changchun

Research site, Hangzhou

All Listed Sponsors
lead

Merck KGaA, Darmstadt, Germany

INDUSTRY

NCT03523390 - Phase I/Ib Multiple Ascending Dose Study in China | Biotech Hunter | Biotech Hunter