Study of ONO-7914 Alone and in Combination With ONO-4538 in Patients With Solid Tumors

Ono Pharmaceuticals

Status and phase: Terminated; Phase 1

Conditions: Solid Tumor

Treatments: Drug: ONO-7914; Drug: ONO-4538

Study type: Interventional

Funder types: Industry

Identifiers

NCT06535009

ONO-7914-01

Details and patient eligibility

About

This study is dose escalation study to evaluate the tolerability and safety of ONO-7914 alone and in combination with ONO-4538 in patients with advanced or metastatic solid tumors

Enrollment: 25 patients

Sex: All

Ages: 20 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients with advanced or metastatic solid tumor
2. Patients with ECOG performance status of 0 or 1
3. Patients with a life expectancy of at least 3 months

Exclusion criteria

1. Patients with severe complication
2. Patients judged to be incapable of providing consent for reasons such as concurrent dementia

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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25 participants in 2 patient groups

ONO-7914

Experimental group

Treatment:

Drug: ONO-7914

ONO-7914+ONO-4538

Experimental group

Treatment:

Drug: ONO-4538

Drug: ONO-7914