Special Combination of OBP-301 and Pembrolizumab

Phase 1

Completed

• Conditions: Advanced Solid Tumor
• Interventions: Biological: OBP-301; Drug: Pembrolizumab

• Registration Number: NCT03172819
• Lead Sponsor: Toshihiko Doi

Brief Summary

This is multicenter, open-label Phase I study to exploratively evaluate the efficacy and safety of OBP-301 in combination with Pembrolizumab in patients with advanced solid tumors.

Detailed Description

Phase 1a part:

To evaluate safety and tolerability in combination of OBP-301 and Pembrolizumab in patient with advanced or metastatic solid tumor and to determine recommended dose in phase 1b part.

Phase 1b part:

To evaluate safety and potential efficacy in combination of OBP-301 and Pembrolizumab in patients in expanded arm.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-05-30
• Study First Submitted QC: 2017-05-31
• Study First Posted: 2017-06-01
• Study Start: 2017-10-01
• Primary Completion: 2021-04-06
• Study Completion: 2022-04-06
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-26
• Last Update Posted: 2022-09-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
OBP-301+Pembrolizumab	OBP-301	OBP-301+Pembrolizumab
OBP-301+Pembrolizumab	Pembrolizumab	OBP-301+Pembrolizumab

Primary Outcome Measures

Name	Time	Method
Dose limiting toxicity (DLT)	4weeks	Dose limiting toxicity

Secondary Outcome Measures

Name	Time	Method
Rate of adverse event	3 years	Rate of adverse event
Response rate (RR)	3 years	Response rate by RECIST ver. 1.1
Progression free survival (PFS)	3 years	Progression free survival

Trial Locations

Locations (1)

National Cancer Center Hospital East; 🇯🇵 Kashiwa, Chiba, Japan