Safety Study of an Immune Response Modifier in Patients With Refractory Solid Organ Tumors

Phase I, Open Label Safety, Pharmacokinetic, and Pharmacodynamic Dose Escalation/De-escalation Study of 852A Administered Intravenously to Subjects With Refractory Solid Organ Tumors

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00095160

Enrollment

Registered

2004-11-02

Start date

2003-10-31

Completion date

2006-01-31

Last updated

2017-11-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neoplasms

Keywords

Solid Organ Tumors

Brief summary

Study 1493-852A is a phase 1 study with the primary objective of determining safety and the highest tolerated dose of an experimental immune response modifier administered intravenously to patients with solid organ tumors not responsive to currently available treatments. The secondary objective of the study is to monitor the tumor response to this form of treatment.

Interventions

DRUG852A

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Have solid organ tumors refractory to currently available treatments. * Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2 * Have a life expectancy of 4 months * Have normal organ and bone marrow function

Exclusion criteria

* Have had biologic, hormonal, anti-neoplastic chemotherapy, or radiation therapy within 4 weeks prior to the 1st dose of the study drug or those who have not recovered from adverse events from agents administered more than 4 weeks earlier. * Use of investigational agent in the 4 weeks prior to 1st dose of the study drug * Use of immunosuppressive therapy in the 4 weeks prior to the 1st dose * Have a history of, or clinical evidence of, myocardial ischemia, congestive heart failure, or myocardial arrhythmias requiring treatment within the past 6 months * Have uncontrolled intercurrent or chronic illness, but not limited to, ongoing or active infection such as hepatitis B or C, immune dysfunction such as autoimmune disease, endocrine dysfunction such as hypo- or hyperthyroidism, psychiatric illness such as depression or suicidal tendency or social situations that would limit compliance with study requirements * Have a history of disease requiring ongoing steroid treatment * Have a history of seizure disorders uncontrolled on medication * Have a history of clinically significant coagulation or bleeding disorders or abnormalities * Are HIV positive. HIV positive subjects are excluded from the study because of possible interactions with the immunomodulatory effects of 852A and because of potential pharmacokinetic interactions associated with combination retroviral therapy. * Are pregnant or lactating

Design outcomes

Primary

Measure	Time frame
Safety and Pharmacokinetics	—

Secondary

Measure	Time frame
Tumor Response	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026