A Study of ONO-7428 in Participants With Unresectable Advanced or Recurrent Solid Tumors
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorOno Pharmaceutical Co., Ltd.
About this trial
This study is to evaluate the tolerability and safety of ONO-7428 in participants with unresectable advanced or recurrent solid tumors.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Participants with histologically or cytologically confirmed unresectable advanced or recurrent solid tumors.
Participants who are refractory or intolerant to standard therapy.
Participants with a tumor type for which anti-PD-(L)1 antibodies have been approved and who have previously treated with anti-PD-(L)1 antibody containing regimen.
Participants with Eastern Cooperative Oncology Group Performance Status 0 or 1.
Disqualifiers
Participants with a complication or history of severe hypersensitivity to any other antibody drugs.
Participants with concurrent autoimmune disease or a history of chronic or recurrent autoimmune disease
Participants with severe peritoneal dissemination.
Participants with pericardial fluid, pleural effusion, or ascites requiring treatment.
Trial design
Design model
Single group
Treatments tested in this trial
ONO-7428
DrugSpecified dose on specified days
Treatment groups
60 Participants
are divided into 1 treatment groupGroup A: ONO-7428Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Dose-limiting toxicities（DLT）
Time frame
21 days2
Adverse event (AE)
Time frame
Up to 2 yearsSecondary outcomes
1
Cmax
Time frame
Up to 2 years2
Tmax
Time frame
Up to 2 years3
Area under the Plasma Concentration versus Time Curve (AUC)
Time frame
Up to 2 years4
Ctrough
Time frame
Up to 2 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov