Clinical trial NCT06816108: A Study of ONO-7428 in Participants With Unresectable Advanced or Recurrent Solid Tumors
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Solid Tumor
NSCLC
Lead sponsor: Ono Pharmaceutical Co. Ltd
Sponsor class: INDUSTRY
First posted: 2025-02-10
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is to evaluate the tolerability and safety of ONO-7428 in participants with unresectable advanced or recurrent solid tumors.


Eligibility criteria: Inclusion Criteria:

1. 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.
2. Participants who are refractory or intolerant to standard therapy.
3. 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.
4. Participants with Eastern Cooperative Oncology Group Performance Status 0 or 1.
5. Participants with tumor tissue samples available for biomarker testing.

Exclusion Criteria:

1. Participants with a complication or history of severe hypersensitivity to any other antibody drugs.
2. Participants with concurrent autoimmune disease or a history of chronic or recurrent autoimmune disease
3. Participants with severe peritoneal dissemination.
4. Participants with pericardial fluid, pleural effusion, or ascites requiring treatment.
5. Participants with uncontrolled tumor-related pain.
6. Participants with active or history of interstitial lung disease or pulmonary fibrosis.

Primary outcomes:
measure: Dose-limiting toxicities（DLT）
timeFrame: 21 days
measure: Adverse event (AE)
timeFrame: Up to 2 years
Secondary outcomes:
measure: Cmax
timeFrame: Up to 2 years
measure: Tmax
timeFrame: Up to 2 years
measure: Area under the Plasma Concentration versus Time Curve (AUC)
timeFrame: Up to 2 years
measure: Ctrough
timeFrame: Up to 2 years
measure: Objective Response Rate (ORR)
timeFrame: Up to 2 years
measure: Disease Control Rate (DCR)
timeFrame: Up to 2 years
measure: Overall Survival (OS)
timeFrame: Up to 2 years
measure: Progression-Free Survival (PFS)
timeFrame: Up to 2 years
measure: Duration of Response (DOR)
timeFrame: Up to 2 years
measure: Time to Response (TTR)
timeFrame: Up to 2 years
measure: Best Overall Response (BOR)
timeFrame: Up to 2 years
measure: Percent change from baseline in the sum of diameters of target lesions
timeFrame: Up to 2 years
measure: Best reduction percent change from baseline in the sum of diameters of target lesions
timeFrame: Up to 2 years
Other outcomes:
Locations:
city: Kashiwa-shi
country: Japan
facility: National Cancer Center Hospital East
state: Chiba
city: Osaka-shi
country: Japan
facility: Osaka International Cancer Institute
state: Osaka
city: Koto-Ku
country: Japan
facility: The Cancer Institute Hospital Of JFCR
state: Tokyo
Study officials:
affiliation: Ono Pharmaceutical Co. Ltd
name: Project Leader
role: STUDY_DIRECTOR
References: