Clinical trial NCT03155061: Study of ONO-4578 With and Without ONO-4538 in Subjects Advanced or Metastatic Solid Tumors
Official title: 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Advanced or Metastatic Solid Tumors
Lead sponsor: Ono Pharmaceutical Co. Ltd
Sponsor class: INDUSTRY
First posted: 2017-05-16
Enrollment: 183
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief 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 criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Patients with severe complication
* Patients with multiple primary cancers

Primary outcomes:
measure: Evaluation of the safety (adverse event, clinical laboratory test, 12-lead electrocardiography, chest X-ray, ECOG performance status)
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
measure: Maximum observed serum concentration(Cmax)
timeFrame: Up to Cycle 1 (each cycle is 28 days)
measure: Area Under the blood concentration-time Curve(AUC)
timeFrame: Up to Cycle 1 (each cycle is 28 days)
measure: Half-life(T1/2) of ONO-4578 both alone and in combination with ONO-4538
timeFrame: Up to Cycle 1 (each cycle is 28 days)
Other outcomes:
Locations:
city: Nagoya
country: Japan
facility: Aichi Clinical Site 1
state: Aichi
city: Toyoake
country: Japan
facility: Aichi Clinical Site 2
state: Aichi
city: Kashiwa
country: Japan
facility: Chiba Clinical Site 1
state: Chiba
city: Matsuyama
country: Japan
facility: Ehime Clinical Site1
state: Ehime
city: Ota
country: Japan
facility: Gunma Clinical Site 1
state: Gunma
city: Sapporo
country: Japan
facility: Hokkaido Clinical Site 1
state: Hokkaido
city: Yahaba-cho
country: Japan
facility: Iwate Clinical Site 1
state: Iwate
city: Sagamihara
country: Japan
facility: Kanagawa Clinical Site 2
state: Kanagawa
city: Yokohama
country: Japan
facility: Kanagawa Clinical Site 1
state: Kanagawa
city: Hirakata
country: Japan
facility: Osaka Clinical Site 2
state: Osaka
city: Sakai
country: Japan
facility: Osaka Clinical Site 3
state: Osaka
city: Takatsuki
country: Japan
facility: Osaka Clinical Site 4
state: Osaka
city: Hidaka
country: Japan
facility: Saitama Clinical Site 2
state: Saitama
city: Ina-machi
country: Japan
facility: Saitama Clinical Site 1
state: Saitama
city: Nagaizumi-Cho
country: Japan
facility: Shizuoka Clinical Site 1
state: Shizuoka
city: Chuo-ku
country: Japan
facility: Tokyo Clinical Site 1
state: Tokyo
city: Itabashi-ku
country: Japan
facility: Tokyo Clinical Site 4
state: Tokyo
city: Koto-ku
country: Japan
facility: Tokyo Clinical Site 2
state: Tokyo
city: Shinjyuku-ku
country: Japan
facility: Tokyo Clinical Site 3
state: Tokyo
city: Fukuoka
country: Japan
facility: Fukuoka Clinical Site 1
city: Fukuoka
country: Japan
facility: Fukuoka Clinical Site 2
city: Osaka
country: Japan
facility: Osaka Clinical Site 1
Study officials:
affiliation: Ono Pharmaceutical Co. Ltd
name: Project Leader
role: STUDY_DIRECTOR
References:
citation: Iwasa S, Koyama T, Nishino M, Kondo S, Sudo K, Yonemori K, Yoshida T, Tamura K, Shimizu T, Fujiwara Y, Kitano S, Shimomura A, Sato J, Yokoyama F, Iida H, Kondo M, Yamamoto N. First-in-human study of ONO-4578, an antagonist of prostaglandin E2 receptor 4, alone and with nivolumab in solid tumors. Cancer Sci. 2023 Jan;114(1):211-220. doi: 10.1111/cas.15574. Epub 2022 Nov 4.