A Study of ONO-7429 in Participants With Unresectable Advanced or Recurrent Solid Tumors
ConditionSolid 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-7429 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 Eastern Cooperative Oncology Group Performance Status 0 or 1.
Participants with tumor tissue samples available for biomarker testing.
Disqualifiers
Participants with a history or presence of severe hypersensitivity to any other antibody agents.
Participants with pericardial fluid, pleural effusion or ascites requiring treatment
Participants with uncontrolled tumor-related pain
Participants with severe peritoneal dissemination.
Trial design
Design model
Single group
Treatments tested in this trial
ONO-7429
DrugSpecified dose on specified days
Treatment groups
80 Participants
are divided into 1 treatment groupGroup A: ONO-7429Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Dose-limiting toxicities（DLT）
Time frame
From first dose through completion of the DLT evaluation period (approximately 21 days)2
Adverse event (AE)
Time frame
Approximately 6 monthsSecondary outcomes
1
Area under the Plasma Concentration versus Time Curve (AUC)
Time frame
Approximately 6 months2
Cmax
Time frame
Approximately 6 months3
Tmax
Time frame
Approximately 6 months4
Terminal elimination half-life（T1/2）
Time frame
Approximately 6 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov