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Study of ONO-4578 With and Without ONO-4538 in Subjects Advanced or Metastatic Solid Tumors

Sponsor
Ono Pharmaceutical Co. Ltd (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT03155061
Collaborator
(none)
183
Enrollment
1
Location
4
Arms
100.7
Anticipated Duration (Months)
1.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The objective of the study is to evaluate the safety, tolerability, pharmacokinetics, efficacy and biomarker of ONO-4578 and combinations of ONO-4578 and ONO-4538 in subjects with advanced or metastatic solid tumors and subjects with unresectable, advanced or recurrent gastric cancer, unresectable, advanced or recurrent colorectal cancer.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
183 participants
Allocation:
Non-Randomized
Intervention Model:
Sequential Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Phase 1 Dose Escalating and Expansion Study of ONO-4578 Given as Monotherapy and Combinations of ONO-4578 and ONO-4538 in Subjects With Advanced or Metastatic Solid Tumors
Actual Study Start Date :
Apr 10, 2017
Anticipated Primary Completion Date :
Sep 1, 2025
Anticipated Study Completion Date :
Sep 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Part A (Dose Escalation Part): ONO-4578 monotherapy

ONO-4578 specified dose on specified days in advanced or metastatic solid tumors

Drug: ONO-4578
ONO-4578 specified dose on specified days
Experimental: Part B: ONO-4578 in combination with ONO-4538

ONO-4578+ONO-4538 specified dose on specified days in advanced or metastatic solid tumors

Drug: ONO-4578
ONO-4578 specified dose on specified days

Drug: ONO-4538
ONO-4538 specified dose on specified days
Experimental: Part C (Expansion Part): ONO-4578 in combination with ONO-4538

ONO-4578+ONO-4538 specified dose on specified days in unresectable, advanced or recurrent gastric cancer

Drug: ONO-4578
ONO-4578 specified dose on specified days

Drug: ONO-4538
ONO-4538 specified dose on specified days
Experimental: Part D (Expansion Part): ONO-4578 in combination with ONO-4538

ONO-4578+ONO-4538 specified dose on specified days in unresectable, advanced or recurrent colorectal cancer

Drug: ONO-4578
ONO-4578 specified dose on specified days

Drug: ONO-4538
ONO-4538 specified dose on specified days

Outcome Measures

Primary Outcome Measures

  1. Evaluation of the safety (adverse event, clinical laboratory test, 12-lead electrocardiography, chest X-ray, ECOG performance status) [Through study completion, an average of 1 year]

Secondary Outcome Measures

  1. Maximum observed serum concentration(Cmax) [Up to Cycle 1 (each cycle is 28 days)]

  2. Area Under the blood concentration-time Curve(AUC) [Up to Cycle 1 (each cycle is 28 days)]

  3. Half-life(T1/2) of ONO-4578 both alone and in combination with ONO-4538 [Up to Cycle 1 (each cycle is 28 days)]

Eligibility Criteria

Criteria

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

  • Advanced or metastatic solid tumors (Part A, B)

  • Unresectable, advanced or recurrent gastric cancer previously treated with anti-PD-(L)1 antibodies or naive to anti-PD-(L)1 antibodies (Part C)

  • Unresectable, advanced or recurrent colorectal cancer(Part D)

  • Life expectancy of at least 3 months

  • Patients with ECOG performance status 0 or 1

Exclusion Criteria:

  • Patients with severe complication

  • Patients with multiple primary 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: Maki Kondou, Ono Pharmaceutical Co. Ltd

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ono Pharmaceutical Co. Ltd
ClinicalTrials.gov Identifier:
NCT03155061
Other Study ID Numbers:
  • ONO-4578-01
First Posted:
May 16, 2017
Last Update Posted:
Dec 17, 2021
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 Dec 17, 2021