Overview
A Dose-Escalation Study of OBP-801 in Patients With Advanced Solid Tumors
Status:
Unknown status
Unknown status
Trial end date:
2019-08-01
2019-08-01
Target enrollment:
0
0
Participant gender:
All
All
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.Phase:
Phase 1Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Oncolys BioPharma Inc
Criteria
Patient Inclusion CriteriaPatients 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.