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NCT Number: NCT03155061

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Advanced or Metastatic Solid Tumors

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Aichi Clinical Site 1, Nagoya, Aichi-ken, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ONO-4578

Drug

ONO-4578 specified dose on specified days

ONO-4538

Drug

ONO-4538 specified dose on specified days

Primary outcomes

  1. Evaluation of the safety (adverse event, clinical laboratory test, 12-lead electrocardiography, chest X-ray, ECOG performance status)

    Time frame: Through study completion, an average of 1 year

Secondary outcomes

  1. Maximum observed serum concentration(Cmax)

    Time frame: Up to Cycle 1 (each cycle is 28 days)

  2. Area Under the blood concentration-time Curve(AUC)

    Time frame: 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

    Time frame: Up to Cycle 1 (each cycle is 28 days)

Sponsors and collaborators

Lead sponsor

Ono Pharmaceutical Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2027
Study completion
2027
First posted
May 16, 2017
Registry last updated
Jun 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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