Phase 1 Dose Escalating and Expansion Study of ONO-4578 Given as Monotherapy and Combinations of ONO-4578 and ONO-4538 in Subjects With Advanced or Metastatic Solid Tumors
Who is this study for? Patients with advanced or metastatic solid tumors and subjects with unresectable, advanced or recurrent gastric cancer
What treatments are being studied? ONO-4578
Status: Active_not_recruiting
Location: See all (22) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY
The objective of the study is to evaluate the safety, tolerability, pharmacokinetics, efficacy and biomarker of ONO-4578 and combinations of ONO-4578 and ONO-4538 in subjects with advanced or metastatic solid tumors and subjects with unresectable, advanced or recurrent gastric cancer, unresectable, advanced or recurrent colorectal cancer.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 20
Healthy Volunteers: f
View:
• Advanced or metastatic solid tumors (Part A, B)
• Unresectable, advanced or recurrent gastric cancer previously treated with anti-PD-(L)1 antibodies or naive to anti-PD-(L)1 antibodies (Part C)
• Unresectable, advanced or recurrent colorectal cancer(Part D)
• Life expectancy of at least 3 months
• Patients with ECOG performance status 0 or 1
Locations
Other Locations
Japan
Tokyo Clinical Site 1
Chuo-ku
Fukuoka Clinical Site 1
Fukuoka
Fukuoka Clinical Site 2
Fukuoka
Saitama Clinical Site 2
Hidaka
Osaka Clinical Site 2
Hirakata
Saitama Clinical Site 1
Ina-machi
Tokyo Clinical Site 4
Itabashi-ku
Chiba Clinical Site 1
Kashiwa
Tokyo Clinical Site 2
Koto-ku
Ehime Clinical Site1
Matsuyama
Shizuoka Clinical Site 1
Nagaizumi-cho
Aichi Clinical Site 1
Nagoya
Osaka Clinical Site 1
Osaka
Gunma Clinical Site 1
Ōta
Kanagawa Clinical Site 2
Sagamihara
Osaka Clinical Site 3
Sakai
Hokkaido Clinical Site 1
Sapporo
Tokyo Clinical Site 3
Shinjyuku-ku
Osaka Clinical Site 4
Takatsuki
Aichi Clinical Site 2
Toyoake
Iwate Clinical Site 1
Yahaba-cho
Kanagawa Clinical Site 1
Yokohama
Time Frame
Start Date: 2017-04-19
Completion Date: 2027-03
Participants
Target number of participants: 183
Treatments
Experimental: Part A (Dose Escalation Part): ONO-4578 monotherapy
ONO-4578 specified dose on specified days in advanced or metastatic solid tumors
Experimental: Part B: ONO-4578 in combination with ONO-4538
ONO-4578+ONO-4538 specified dose on specified days in advanced or metastatic solid tumors
Experimental: Part C (Expansion Part): ONO-4578 in combination with ONO-4538
ONO-4578+ONO-4538 specified dose on specified days in unresectable, advanced or recurrent gastric cancer
Experimental: Part D (Expansion Part): ONO-4578 in combination with ONO-4538
ONO-4578+ONO-4538 specified dose on specified days in unresectable, advanced or recurrent colorectal cancer
Related Therapeutic Areas
Sponsors
Leads: Ono Pharmaceutical Co. Ltd