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

Study Overview
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Brief Summary
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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.

Official Title
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Phase 1 Dose Escalating and Expansion Study of ONO-4578 Given as Monotherapy and Combinations of ONO-4578 and ONO-4538 in Subjects With Advanced or Metastatic Solid Tumors

Conditions
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Advanced or Metastatic Solid Tumors

Intervention / Treatment
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* Drug: ONO-4578
* Drug: ONO-4538


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Part A (Dose Escalation Part): ONO-4578 monotherapy<br>ONO-4578 specified dose on specified days in advanced or metastatic solid tumors | Drug: ONO-4578<br>* ONO-4578 specified dose on specified days<br>|
| Experimental: Part B: ONO-4578 in combination with ONO-4538<br>ONO-4578+ONO-4538 specified dose on specified days in advanced or metastatic solid tumors | Drug: ONO-4578<br>* ONO-4578 specified dose on specified days<br>Drug: ONO-4538<br>* ONO-4538 specified dose on specified days<br>|
| Experimental: Part C (Expansion Part): ONO-4578 in combination with ONO-4538<br>ONO-4578+ONO-4538 specified dose on specified days in unresectable, advanced or recurrent gastric cancer | Drug: ONO-4578<br>* ONO-4578 specified dose on specified days<br>Drug: ONO-4538<br>* ONO-4538 specified dose on specified days<br>|
| Experimental: Part D (Expansion Part): ONO-4578 in combination with ONO-4538<br>ONO-4578+ONO-4538 specified dose on specified days in unresectable, advanced or recurrent colorectal cancer | Drug: ONO-4578<br>* ONO-4578 specified dose on specified days<br>Drug: ONO-4538<br>* ONO-4538 specified dose on specified days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of the safety (adverse event, clinical laboratory test, 12-lead electrocardiography, chest X-ray, ECOG performance status) |  | Through study completion, an average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum observed serum concentration(Cmax) |  | Up to Cycle 1 (each cycle is 28 days) | 
| Area Under the blood concentration-time Curve(AUC) |  | Up to Cycle 1 (each cycle is 28 days) | 
| Half-life(T1/2) of ONO-4578 both alone and in combination with ONO-4538 |  | Up to Cycle 1 (each cycle is 28 days) |