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NCT Number: NCT06548217

A Phase I Study of ONO-4538HSC in Subjects With Advanced or Metastatic Solid Tumors

This is a multicenter, open-label, uncontrolled, phase I study to evaluate the tolerability, safety, pharmacokinetics, and efficacy of ONO-4538HSC administered subcutaneously in participants with advanced or metastatic solid tumors. This study consists of the tolerability confirmation part to determine the recommended dose for Japanese participants by evaluating the DLTs and the expansion part to evaluate the safety and pharmacokinetics and to explore the efficacy.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Advanced or Metastatic Solid Tumors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

National Cancer Center Hospital East, Kashiwa-shi, Chiba, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patient with advanced or metastatic solid tumors
  • Patients have an ECOG performance status of 0 to 1
  • Patients with a life expectancy of at least 3 months

[Tolerability confirmation part]

  • Patients who are refractory or intolerant to standard therapy or for whom no standard therapy is available

[Expansion part]

  • Patients who are refractory or intolerant to standard therapy, or for whom no standard therapy is available, or for whom monotherapy with intravenous nivolumab is indicated according to the package insert

Exclusion criteria

  • Patients with a complication or history of severe hypersensitivity to any antibody product
  • Patients with severe complication

Treatment and study plan

ONO-4538HSC

Drug

ONO-4538HSC will be administered subcutaneously once every 4 weeks.

Primary outcomes

  1. Dose-limiting toxicities (DLT)

    Time frame: 28 days

  2. Adverse event (AE)

    Time frame: UP to 100 days after the last dose

Secondary outcomes

  1. Pharmacokinetics（serum concentration of Nivolumab）

    Time frame: Up to Cycle25 (each cycle is 28 days) and Post-treatment observation phase (28 days after the end of treatment phase)

Other outcomes

  1. Overall response rate (ORR)

    Time frame: Through study completion, an average of 6 months

  2. Disease control rate (DCR)

    Time frame: Through study completion, an average of 6 months

  3. Overall survival (OS)

    Time frame: Through study completion, an average of 6 months

  4. Progression-free survival (PFS)

    Time frame: Through study completion, an average of 6 months

  5. Duration of response (DOR)

    Time frame: Through study completion, an average of 6 months

  6. Time to response (TTR)

    Time frame: Through study completion, an average of 6 months

  7. Best overall response (BOR)

    Time frame: Through study completion, an average of 6 months

  8. Percentage of change in the sum of tumor diameters of target lesions

    Time frame: Through study completion, an average of 6 months

  9. Maximum percent change in the sum diameters of the target lesions

    Time frame: Through study completion, an average of 6 months

  10. Anti-Nivolumab antibody

    Time frame: Up to Cycle25 (each cycle is 28 days) and Post-treatment observation phase (28 days after the end of treatment phase)

  11. Anti-rHuPH20 antibody

    Time frame: Up to Cycle25 (each cycle is 28 days) and Post-treatment observation phase (28 days after the end of treatment phase)

Sponsors and collaborators

Lead sponsor

Ono Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

An Open-label, Uncontrolled, Phase I Study of ONO-4538HSC in Subjects With Advanced or Metastatic Solid Tumors

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Aug 12, 2024
Registry last updated
Jul 3, 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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