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

A Phase I, Open-label, Uncontrolled, 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

Status
Terminated
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06535009
Enrollment
25
Registered
2024-08-02
Start date
2022-02-08
Completion date
2025-02-26
Last updated
2025-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Solid Tumor

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

Interventions

DRUGONO-7914

Specified dose on specified days

DRUGONO-4538

Specified dose on specified days

Sponsors

Ono Pharmaceutical Co. Ltd
Lead SponsorINDUSTRY

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Dose Limiting Toxicity28 days
Adverse Events as assessed by CTCAE v5.0Up to 28 days after the completion of treatment period

Secondary

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

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026