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Completed

NCT Number: NCT03730337

Phase 1 Study of ONO-7475 With and Without ONO-4538 in Subjects Advanced or Metastatic Solid Tumors

To evaluate the tolerability and safety of ONO-7475 monotherapy and combinations with ONO-4538 in patients with advanced or metastatic solid tumors

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Key information

Conditions

Advanced or Metastatic Solid Tumors

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Tokyo Clinical Site

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 0～1
  • Patients with life expectancy of at least 3 months

Exclusion criteria

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

Treatment and study plan

ONO-7475

Drug

ONO-7475 specified dose on specified days

ONO-7475 + ONO-4538

Drug

ONO-7475+ONO-4538 specified dose on specified days

Primary outcomes

  1. Number of paticipants with dose-limiting toxicities during the DLT evaluation period

    Time frame: 28 days

  2. Incidence and severity of adverse events as assessed by CTCAE v4.0 to determine the tolerability and safety

    Time frame: Through study completion, an average of 1 year

Secondary outcomes

  1. Pharmacokinetics (Cmax)

    Time frame: Through study completion

    Assessment of the maximum plasma concentration of ONO-7475 both alone and in combination with ONO-4538

  2. Pharmacokinetics (Tmax)

    Time frame: Through study completion

    Assessment of the time to reach maximum observed plasma concentration of ONO-7475 both alone and in combination with ONO-4538

  3. Pharmacokinetics (AUC)

    Time frame: Through study completion

    Assessment of the plasma area under the curve of ONO-7475 both alone and in combination with ONO-4538

Sponsors and collaborators

Lead sponsor

Ono Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

Open-label, Uncontrolled, Dose-escalation Study of ONO-7475 Given as Monotherapy and Combinations With ONO-4538 in Patients With Advanced or Metastatic Solid Tumors

Important dates

Study start
2018
Primary completion
2021
Study completion
2022
First posted
Nov 5, 2018
Registry last updated
Oct 4, 2023

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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