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

Solid Tumor Clinical Trial

Official title:

A Phase 1a Dose-Escalation Study of OBP-801 in Patients With Advanced Solid Tumors

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02414516
• Other study ID #: OBP-801-001
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: March 2015
• Est. completion date: August 2019

Study information

• Verified date: March 2019
• Source: Oncolys BioPharma Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 17
• Est. completion date: August 2019
• Est. primary completion date: June 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Patient Inclusion Criteria

Patients must meet all of the following inclusion criteria to be eligible for enrollment into the study:

• Histologically or cytologically confirmed metastatic or unresectable solid tumor.

• Has failed treatment with all standard therapies for their malignancy.

• Adequate Karnofsky Performance Status.

• An expected survival of at least 3 months.

• Adequate organ and bone marrow function.

• Signed informed consent form for study participation prior to screening.

Patient Exclusion Criteria

Patients presenting with any of the following will be excluded in the study:

• Clinically significant disease as defined by the protocol.

• Surgical therapy or other therapies within period as defined by the protocol.

• Any condition that will interfere with compliance with the protocol as determined by investigator.

Related Conditions & MeSH terms

• Solid Tumor

Intervention

Drug:
• OBP-801
OBP-801 will be administered IV

Locations

Country	Name	City	State
United States	Barbara Ann Karmanos Cancer Institute	Detroit	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Oncolys BioPharma Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum Tolerated Dose		6 weeks
Secondary	Pharmacokinetic (PK) profile; AUC, Cmax, and t1/2		4 weeks
Secondary	Objective Response (OR)		22 weeks
Secondary	Durability of Objective Response (DOR)		22 weeks