ONO-7429
DrugSpecified dose on specified days
Recruiting
NCT Number: NCT07787208
A Study of ONO-7429 in Participants With Unresectable Advanced or Recurrent Solid Tumors
This study is to evaluate the tolerability and safety of ONO-7429 in participants with unresectable advanced or recurrent solid tumors.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 1
Primary location
National Cancer Center Hospital East, Kashiwa, Chiba, Japan
Loading trial locations.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- 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.
Exclusion criteria
- 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.
- Participants with multiple primary cancers.
- Participants with a history or presence of ILD or pulmonary fibrosis.
Treatment and study plan
Primary outcomes
-
Dose-limiting toxicities（DLT）
Time frame: From first dose through completion of the DLT evaluation period (approximately 21 days)
-
Adverse event (AE)
Time frame: Approximately 6 months
Secondary outcomes
-
Area under the Plasma Concentration versus Time Curve (AUC)
Time frame: Approximately 6 months
-
Cmax
Time frame: Approximately 6 months
-
Tmax
Time frame: Approximately 6 months
-
Terminal elimination half-life（T1/2）
Time frame: Approximately 6 months
-
Ctrough
Time frame: Approximately 6 months
-
CL
Time frame: Approximately 6 months
-
Volume of distribution at steady state（Vss）
Time frame: Approximately 6 months
-
Objective Response Rate (ORR)
Time frame: Approximately 6 months
-
Disease Control Rate (DCR)
Time frame: Approximately 6 months
-
Best overall response（BOR）
Time frame: Approximately 6 months
-
Duration of Response (DOR)
Time frame: Approximately 6 months
-
Progression-Free Survival (PFS)
Time frame: Approximately 6 months
-
Overall Survival (OS)
Time frame: Approximately 6 months
-
Time to Response (TTR)
Time frame: Approximately 6 months
-
Percent change from baseline in the sum of diameters of target lesions
Time frame: Approximately 6 months
-
Best percent change from baseline in the sum of diameters of target lesions
Time frame: Approximately 6 months
Study contacts
Contact information is provided by the study sponsor or research team.
International Clinical Trial Support Desk
CONTACT
+17162141777(Standard)
North America Clinical Trial Support Desk
CONTACT
+18665877745(Toll-Free)
Sponsors and collaborators
Lead sponsor
Ono Pharmaceutical Co., Ltd.
Industry
Registry information
Official study title
A Phase 1, Open-label, Dose Escalation Study to Investigate the Safety and Tolerability of ONO-7429 in Participants With Unresectable Advanced or Recurrent Solid Tumors
Important dates
- Study start
- 2026
- Primary completion
- 2028
- Study completion
- 2030
- First posted
- Aug 26, 2026
- Registry last updated
- Aug 26, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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