ONO-7913 Phase I Study (ONO-7913)

An Open-label, Uncontrolled, Dose Escalation Study in Patients With Advanced or Metastatic Solid Cancers (ONO-7913-01)

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04403308

Enrollment

Registered

2020-05-27

Start date

2020-07-28

Completion date

2022-01-13

Last updated

2024-05-03

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

Conditions

Solid Tumor

Brief summary

To assess the tolerability, safety, and pharmacokinetics (PK) of ONO-7913 in patients with advanced or metastatic solid cancers and explore its efficacy and biomarkers.

Interventions

BIOLOGICALONO-7913

ONO-7913 will be administered by intravenous continuous infusion during the designated time.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Patients with histologically or cytologically confirmed advanced or metastatic solid tumors 2. ECOG Performance Status of 0-1 3. Patients with life expectancy of at least 3 months

Exclusion criteria

1. Patients with multiple cancers 2. Patients with history of serious allergy

Design outcomes

Primary

Measure	Time frame	Description
Dose-limiting toxicities	28 days	Number of participants with a DLT
Adverse events	Up to 24 months	Assessed by the NCI CTCAE v5.0 criteria

Secondary

Measure	Time frame	Description
Concentration vs time of ONO-7913 as single dose	Up to 24 months	PK profile

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 28, 2026