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OpenTrials
Completed

NCT Number: NCT04403308

ONO-7913 Phase I Study (ONO-7913)

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.

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Key information

Conditions

Solid Tumor

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Local Institution

Chuo-ku, Tokyo, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Patients with multiple cancers
  • Patients with history of serious allergy

Treatment and study plan

ONO-7913

Biological

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

Primary outcomes

  1. Dose-limiting toxicities

    Time frame: 28 days

    Number of participants with a DLT

  2. Adverse events

    Time frame: Up to 24 months

    Assessed by the NCI CTCAE v5.0 criteria

Secondary outcomes

  1. Concentration vs time of ONO-7913 as single dose

    Time frame: Up to 24 months

    PK profile

Sponsors and collaborators

Lead sponsor

Ono Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
May 27, 2020
Registry last updated
May 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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