HM95573 in Combination With Either Cobimetinib or Cetuximab in Patients With Locally Advanced or Metastatic Solid Tumors

PHASE1UnknownINTERVENTIONAL
Enrollment

148

Participants

Timeline

Start Date

May 22, 2017

Primary Completion Date

September 30, 2024

Study Completion Date

December 31, 2024

Conditions
Locally Advanced Solid TumorMetastatic Solid Tumor
Interventions
DRUG

HM95573, cobimetinib

Regimen: twice daily (BID), continuous dosing for HM95573, once daily (QD) 21 days, 7 days off for cobimetinib

DRUG

HM95573, cetuximab

Regimen: twice daily (BID), continuous dosing for HM95573

DRUG

HM95573, cobimetinib

Regimen: Recommended dose (RD) and schedule selected based on the data of safety, tolerability, pharmacokinetics, and anti-tumor activity tested in Stage 1

DRUG

HM95573, cetuximab

Regimen: Expansion dose of HM95573 selected based on the data of safety and tolerability tested in Stage 1b

Trial Locations (9)

10408

National Cancer Center, Goyang-si

13620

Seoul National University Bundang Hospital, Seongnam-si

49201

Dong-A University Hospital, Pusan

58128

Chonnam National University Hwasun Hospital, Hwasun

03080

Seoul National University Hospital, Seoul

03722

Yonsei University Health System Severance Hospital, Seoul

05505

Asan Medical Center, Seoul

06351

Samsung Medical Center, Seoul

07061

Seoul National University Borame Hospital, Seoul

All Listed Sponsors
lead

Hanmi Pharmaceutical Company Limited

INDUSTRY

NCT03284502 - HM95573 in Combination With Either Cobimetinib or Cetuximab in Patients With Locally Advanced or Metastatic Solid Tumors | Biotech Hunter | Biotech Hunter