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

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ClinicalTrials.gov Identifier: NCT03730337
Recruitment Status : Recruiting
First Posted : November 5, 2018
Last Update Posted : November 5, 2018
Sponsor:
Information provided by (Responsible Party):
Ono Pharmaceutical Co. Ltd

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

Condition or disease Intervention/treatment Phase
Advanced or Metastatic Solid Tumors Drug: ONO-7475 Drug: ONO-7475 + ONO-4538 Phase 1

Study Type : Interventional
Estimated Enrollment : 84 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : October 17, 2018
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : April 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Nivolumab

Arm Intervention/treatment
Experimental: ONO-7475 monotherapy Drug: ONO-7475
ONO-7475 specified dose on specified days

Experimental: ONO-7475 in combination with ONO-4538 Drug: ONO-7475 + ONO-4538
ONO-7475+ONO-4538 specified dose on specified days




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03730337


Contacts
Contact: Ono Pharmaceutical Co. Ltd Corporate communications y.tani@ono.co.jp

Locations
Japan
Tokyo Clinical Site Recruiting
Tokyo, Japan
Sponsors and Collaborators
Ono Pharmaceutical Co. Ltd
Investigators
Study Director: Hiroaki Hozumi Ono Pharmaceutical Co. Ltd

Responsible Party: Ono Pharmaceutical Co. Ltd
ClinicalTrials.gov Identifier: NCT03730337     History of Changes
Other Study ID Numbers: ONO-7475-02 / ONO-4538-74
First Posted: November 5, 2018    Key Record Dates
Last Update Posted: November 5, 2018
Last Verified: October 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Nivolumab
Antibodies, Monoclonal
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs