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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-31

Study Completion Date

2019-08-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Solid Tumor

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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OBP-801

Group Type EXPERIMENTAL

OBP-801

Intervention Type DRUG

OBP-801 will be administered IV

Interventions

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OBP-801

OBP-801 will be administered IV

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No