To hear about similar clinical trials, please enter your email below
Trial Title:
A Phase I Study of ONO-4538HSC in Subjects With Advanced or Metastatic Solid Tumors
NCT ID:
NCT06548217
Condition:
Advanced or Metastatic Solid Tumors
Conditions: Official terms:
Neoplasms
Nivolumab
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
ONO-4538HSC
Description:
ONO-4538HSC will be administered subcutaneously once every 4 weeks.
Arm group label:
ONO-4538HSC
Summary:
This is a multicenter, open-label, uncontrolled, phase I study to evaluate the
tolerability, safety, pharmacokinetics, and efficacy of ONO-4538HSC administered
subcutaneously in participants with advanced or metastatic solid tumors. This study
consists of the tolerability confirmation part to determine the recommended dose for
Japanese participants by evaluating the DLTs and the expansion part to evaluate the
safety and pharmacokinetics and to explore the efficacy.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Patient with advanced or metastatic solid tumors
2. Patients have an ECOG performance status of 0 to 1
3. Patients with a life expectancy of at least 3 months
[Tolerability confirmation part]
4. Patients who are refractory or intolerant to standard therapy or for whom no
standard therapy is available
[Expansion part]
5. Patients who are refractory or intolerant to standard therapy, or for whom no
standard therapy is available, or for whom monotherapy with intravenous nivolumab is
indicated according to the package insert
Exclusion Criteria:
1. Patients with a complication or history of severe hypersensitivity to any antibody
product
2. Patients with severe complication
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
National Cancer Center Hospital East
Address:
City:
Kashiwa-shi
Country:
Japan
Status:
Recruiting
Facility:
Name:
National Cancer Center Hospital
Address:
City:
Chuo-ku
Country:
Japan
Status:
Recruiting
Facility:
Name:
The Cancer Institute Hospital Of JFCR
Address:
City:
Koto-ku
Country:
Japan
Status:
Recruiting
Start date:
May 7, 2024
Completion date:
February 29, 2028
Lead sponsor:
Agency:
Ono Pharmaceutical Co. Ltd
Agency class:
Industry
Source:
Ono Pharmaceutical Co. Ltd
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06548217
