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NCT03730337 Clinical Trial

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

Advanced or Metastatic Solid Tumors Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03730337
Other study ID # ONO-7475-02 / ONO-4538-74
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date October 17, 2018
Est. completion date November 22, 2022

Study information
Verified date September 2023
Source Ono Pharmaceutical Co. Ltd
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 24
Est. completion date November 22, 2022
Est. primary completion date June 28, 2021
Accepts healthy volunteers No
Gender All
Age group 20 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

  • Advanced or Metastatic Solid Tumors
  • Neoplasms

Intervention

Drug:
• ONO-7475
ONO-7475 specified dose on specified days
• ONO-7475 + ONO-4538
ONO-7475+ONO-4538 specified dose on specified days

Locations
Country Name City State
Japan Tokyo Clinical Site Tokyo

Sponsors (1)
Lead Sponsor Collaborator
Ono Pharmaceutical Co. Ltd

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of paticipants with dose-limiting toxicities during the DLT evaluation period 28 days
Primary Incidence and severity of adverse events as assessed by CTCAE v4.0 to determine the tolerability and safety Through study completion, an average of 1 year
Secondary Pharmacokinetics (Cmax) Assessment of the maximum plasma concentration of ONO-7475 both alone and in combination with ONO-4538 Through study completion
Secondary Pharmacokinetics (Tmax) Assessment of the time to reach maximum observed plasma concentration of ONO-7475 both alone and in combination with ONO-4538 Through study completion
Secondary Pharmacokinetics (AUC) Assessment of the plasma area under the curve of ONO-7475 both alone and in combination with ONO-4538 Through study completion
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