Study of ONO-7914 Alone and in Combination With ONO-4538 in Patients With Solid Tumors

Phase 1

Active, not recruiting

• Conditions: Solid Tumor
• Interventions: Drug: ONO-7914; Drug: ONO-4538

• Registration Number: NCT06535009
• Lead Sponsor: Ono Pharmaceutical Co. Ltd

Brief Summary

This study is dose escalation study to evaluate the tolerability and safety of ONO-7914 alone and in combination with ONO-4538 in patients with advanced or metastatic solid tumors

Detailed Description

Not available

Study Timeline

• Study Start: 2022-02-08
• Study First Submitted: 2024-07-21
• Study First Submitted QC: 2024-07-30
• Study First Posted: 2024-08-02
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-19
• Last Update Posted: 2025-02-21
• Primary Completion: 2027-03-31
• Study Completion: 2027-09-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 204

Inclusion Criteria

1. Patients with advanced or metastatic solid tumor
2. Patients with ECOG performance status of 0 or 1
3. Patients with a life expectancy of at least 3 months

Exclusion Criteria

1. Patients with severe complication
2. Patients judged to be incapable of providing consent for reasons such as concurrent dementia

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ONO-7914+ONO-4538	ONO-4538	-
ONO-7914	ONO-7914	-
ONO-7914+ONO-4538	ONO-7914	-

Primary Outcome Measures

Name	Time	Method
Adverse Events as assessed by CTCAE v5.0	Up to 28 days after the completion of treatment period
Dose Limiting Toxicity	28 days

Secondary Outcome Measures

Name	Time	Method
Urine concentration of ONO-7914	Up to 24 hours after the first treatment
Plasma concentration of ONO-7914	Up to 21 days after the first treatment
Serum concentration of ONO-4538	Up to 28 days after the completion of treatment period

Trial Locations

Locations (1)

Cancer Institute Hospital of JFCR; 🇯🇵 Koto-ku, Tokyo, Japan