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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE1

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-07

Study Completion Date

2028-02-29

Brief Summary

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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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Detailed Description

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Conditions

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Advanced or Metastatic Solid Tumors

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ONO-4538HSC

Group Type EXPERIMENTAL

ONO-4538HSC

Intervention Type DRUG

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

Interventions

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ONO-4538HSC

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

\[Tolerability confirmation part\]
4. Patients who are refractory or intolerant to standard therapy or for whom no standard therapy is available

\[Expansion part\]
5. 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