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

Oncolys BioPharma

Status and phase

Unknown

Phase 1

Conditions

Solid Tumor

Treatments

Drug: OBP-801

Study type

Interventional

Funder types

Industry

Identifiers

NCT02414516

OBP-801-001

Details and patient eligibility

About

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.

Enrollment

17 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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.