Study of ONO-4578 With and Without ONO-4538 in Subjects Advanced or Metastatic Solid Tumors

Ono Pharmaceuticals

Status and phase: Active, not recruiting; Phase 1

Conditions: Advanced or Metastatic Solid Tumors

Treatments: Drug: ONO-4538; Drug: ONO-4578

Study type: Interventional

Funder types: Industry

Identifiers

NCT03155061

jRCT2080223441 (Registry Identifier)

ONO-4578-01

Details and patient eligibility

About

The objective of the study is to evaluate the safety, tolerability, pharmacokinetics, efficacy and biomarker of ONO-4578 and combinations of ONO-4578 and ONO-4538 in subjects with advanced or metastatic solid tumors and subjects with unresectable, advanced or recurrent gastric cancer, unresectable, advanced or recurrent colorectal cancer.

Enrollment: 183 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Advanced or metastatic solid tumors (Part A, B)
• Unresectable, advanced or recurrent gastric cancer previously treated with anti-PD-(L)1 antibodies or naive to anti-PD-(L)1 antibodies (Part C)
• Unresectable, advanced or recurrent colorectal cancer(Part D)
• Life expectancy of at least 3 months
• Patients with ECOG performance status 0 or 1

Exclusion criteria

• Patients with severe complication
• Patients with multiple primary cancers

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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183 participants in 4 patient groups

Part A (Dose Escalation Part): ONO-4578 monotherapy

Experimental group

Description:

ONO-4578 specified dose on specified days in advanced or metastatic solid tumors

Treatment:

Drug: ONO-4578

Part B: ONO-4578 in combination with ONO-4538

Experimental group

Description:

ONO-4578+ONO-4538 specified dose on specified days in advanced or metastatic solid tumors

Treatment:

Drug: ONO-4578

Drug: ONO-4538

Part C (Expansion Part): ONO-4578 in combination with ONO-4538

Experimental group

Description:

ONO-4578+ONO-4538 specified dose on specified days in unresectable, advanced or recurrent gastric cancer

Treatment:

Drug: ONO-4578

Drug: ONO-4538

Part D (Expansion Part): ONO-4578 in combination with ONO-4538

Experimental group

Description:

ONO-4578+ONO-4538 specified dose on specified days in unresectable, advanced or recurrent colorectal cancer

Treatment:

Drug: ONO-4578

Drug: ONO-4538