NCT06816108Active, not recruitingPhase 1
A Phase I, Open-label, Dose Escalation Study to Evaluate the Tolerability and Safety of ONO-7428 in Participants With Unresectable Advanced or Recurrent Solid Tumors
Ono Pharmaceutical Co., Ltd.15 sites in 1 country35 target enrollmentStarted: April 21, 2025Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 35
- Locations
- 15
- Primary Endpoint
- Adverse event (AE)
Study Overview
Brief Summary
This study is to evaluate the tolerability and safety of ONO-7428 in participants with unresectable advanced or recurrent solid tumors.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Participants with histologically or cytologically confirmed unresectable advanced or recurrent solid tumors.
- •[Backfill cohort only] Participants with histologically or cytologically confirmed Stage IIIB, IIIC, IV, or recurrent NSCLC according to UICC-TNM classification.
- •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
- •Participants with tumor tissue samples available for biomarker testing.
Exclusion Criteria
- •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.
- •Participants with uncontrolled tumor-related pain.
- •Participants with active or history of interstitial lung disease or pulmonary fibrosis.
Arms & Interventions
ONO-7428
Experimental
Intervention: ONO-7428 (Drug)
Outcomes
Primary Outcomes
Adverse event (AE)
Time Frame: Up to 2 years
Dose-limiting toxicities（DLT）
Time Frame: 21 days
Secondary Outcomes
- Ctrough(Up to 2 years)
- Percent change from baseline in the sum of diameters of target lesions(Up to 2 years)
- Disease Control Rate (DCR)(Up to 2 years)
- Area under the Plasma Concentration versus Time Curve (AUC)(Up to 2 years)
- Cmax(Up to 2 years)
- Tmax(Up to 2 years)
- Objective Response Rate (ORR)(Up to 2 years)
- Overall Survival (OS)(Up to 2 years)
- Progression-Free Survival (PFS)(Up to 2 years)
- Duration of Response (DOR)(Up to 2 years)
- Time to Response (TTR)(Up to 2 years)
- Best reduction percent change from baseline in the sum of diameters of target lesions(Up to 2 years)
- Best Overall Response (BOR)(Up to 2 years)
Investigators
Study Sites (15)
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