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

Sponsor
Ono Pharmaceutical Co. Ltd (Industry)
Overall Status
Suspended
CT.gov ID
NCT03730337
Collaborator
(none)
84
Enrollment
1
Location
2
Arms
53.5
Anticipated Duration (Months)
1.6
Patients Per Site Per Month

Study Details

Study Description

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
Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
84 participants
Allocation:
Non-Randomized
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 :
Oct 17, 2018
Anticipated Primary Completion Date :
Apr 1, 2023
Anticipated Study Completion Date :
Apr 1, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Number of paticipants with dose-limiting toxicities during the DLT evaluation period [28 days]

  2. 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 Outcome Measures

  1. Pharmacokinetics (Cmax) [Through study completion]

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

  2. Pharmacokinetics (Tmax) [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) [Through study completion]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Tokyo Clinical Site Tokyo Japan

Sponsors and Collaborators

  • Ono Pharmaceutical Co. Ltd

Investigators

  • Study Director: Hiroaki Hozumi, Ono Pharmaceutical Co. Ltd

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ono Pharmaceutical Co. Ltd
ClinicalTrials.gov Identifier:
NCT03730337
Other Study ID Numbers:
  • ONO-7475-02 / ONO-4538-74
First Posted:
Nov 5, 2018
Last Update Posted:
Jan 11, 2022
Last Verified:
Dec 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Neoplasms
Nivolumab

Study Results

No Results Posted as of Jan 11, 2022