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

Launched by ONO PHARMACEUTICAL CO. LTD · Aug 8, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called ONO-4538HSC for patients with advanced or metastatic solid tumors, which are types of cancer that have spread beyond their original site. The trial aims to find out how well this treatment works, how safe it is, and the best dose to give. It will involve two parts: one to confirm the tolerability of the treatment in Japanese participants and another to further assess safety and effectiveness among a broader group.

To be eligible for this study, participants should have advanced or metastatic solid tumors and a good performance status, meaning they are generally well enough to participate. They should also have a life expectancy of at least three months. Patients who have not responded to standard treatments or for whom standard treatments are not available may be considered for the trial. Participants can expect to receive the treatment through a subcutaneous injection (just under the skin) and will be closely monitored for any side effects and how their cancer responds. It's important to note that patients with certain severe allergies or complications may not be eligible for the study.

Gender

ALL

Eligibility criteria

• 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
• Exclusion Criteria:
• • 1. Patients with a complication or history of severe hypersensitivity to any antibody product
• • 2. Patients with severe complication