- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02414516
A Dose-Escalation Study of OBP-801 in Patients With Advanced Solid Tumors
March 11, 2019 updated by: Oncolys BioPharma Inc
A Phase 1a Dose-Escalation Study of OBP-801 in Patients With Advanced Solid Tumors
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
17
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Michigan
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Detroit, Michigan, United States, 48201-1379
- Barbara Ann Karmanos Cancer Institute
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: OBP-801
|
OBP-801 will be administered IV
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Maximum Tolerated Dose
Time Frame: 6 weeks
|
6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Pharmacokinetic (PK) profile; AUC, Cmax, and t1/2
Time Frame: 4 weeks
|
4 weeks
|
Objective Response (OR)
Time Frame: 22 weeks
|
22 weeks
|
Durability of Objective Response (DOR)
Time Frame: 22 weeks
|
22 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2015
Primary Completion (Anticipated)
June 1, 2019
Study Completion (Anticipated)
August 1, 2019
Study Registration Dates
First Submitted
March 23, 2015
First Submitted That Met QC Criteria
April 9, 2015
First Posted (Estimate)
April 10, 2015
Study Record Updates
Last Update Posted (Actual)
March 13, 2019
Last Update Submitted That Met QC Criteria
March 11, 2019
Last Verified
March 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- OBP-801-001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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-
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Clinical Trials on OBP-801
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Alzheon Inc.Active, not recruitingEarly Alzheimer's DiseaseNetherlands, Czechia
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Altimmune, Inc.Completed
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Stemline Therapeutics, Inc.CompletedSolid TumorsUnited States
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Alzheon Inc.Not yet recruitingEarly Alzheimer's DiseaseUnited States, Canada, United Kingdom