Phase 1 Study of ONO-7475 With and Without ONO-4538 in Subjects Advanced or Metastatic Solid Tumors

Ono Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Advanced or Metastatic Solid Tumors

Treatments: Drug: ONO-7475; Drug: ONO-7475 + ONO-4538

Study type: Interventional

Funder types: Industry

Identifiers

NCT03730337

ONO-7475-02 / ONO-4538-74

Details and patient eligibility

About

To evaluate the tolerability and safety of ONO-7475 monotherapy and combinations with ONO-4538 in patients with advanced or metastatic solid tumors

Enrollment: 24 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with histologically or cytologically confirmed advanced or metastatic solid tumors
• ECOG Performance Status 0～1
• Patients with life expectancy of at least 3 months

Exclusion criteria

• Patients with history of severe allergy
• Patients with multiple cancers

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

24 participants in 2 patient groups

ONO-7475 monotherapy

Experimental group

Treatment:

Drug: ONO-7475

ONO-7475 in combination with ONO-4538

Experimental group

Treatment:

Drug: ONO-7475 + ONO-4538