A Dose-Escalation Study of OBP-801 in Patients With Advanced Solid Tumors

Phase 1

• Conditions: Solid Tumor
• Interventions: Drug: OBP-801

• Registration Number: NCT02414516
• Lead Sponsor: Oncolys BioPharma Inc

Brief Summary

This Phase 1a, single center, open-label, repeat dose study will evaluate the safety, efficacy, and Pharmacokinetics of ascending doses of OBP-801 in patients with advanced solid tumors.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-03
• Study First Submitted: 2015-03-23
• Study First Submitted QC: 2015-04-09
• Study First Posted: 2015-04-10
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-11
• Last Update Posted: 2019-03-13
• Primary Completion: 2019-06
• Study Completion: 2019-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 17

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
OBP-801	OBP-801	-

Primary Outcome Measures

Name	Time	Method
Maximum Tolerated Dose	6 weeks

Secondary Outcome Measures

Name	Time	Method
Durability of Objective Response (DOR)	22 weeks
Objective Response (OR)	22 weeks
Pharmacokinetic (PK) profile; AUC, Cmax, and t1/2	4 weeks

Trial Locations

Locations (1)

Barbara Ann Karmanos Cancer Institute; 🇺🇸 Detroit, Michigan, United States