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

NCT03155061 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 183

Last updated 2025-06-05

No results posted yet for this study

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.

Conditions

  • Advanced or Metastatic Solid Tumors

Interventions

DRUG

ONO-4578

ONO-4578 specified dose on specified days

DRUG

ONO-4538

ONO-4538 specified dose on specified days

Sponsors & Collaborators

  • Ono Pharmaceutical Co. Ltd

    lead INDUSTRY

Principal Investigators

  • Project Leader · Ono Pharmaceutical Co. Ltd

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-04-19
Primary Completion
2027-03-31
Completion
2027-03-31

Countries

  • Japan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03155061 on ClinicalTrials.gov