HuMax-IL8 (Interleukin8) in Patients With Advanced Malignant Solid Tumors

• Status: Completed
• Trial end date: 2016-11-01
• Target enrollment: 0
• Participant gender: All

Summary

A phase Ib, dose escalation, multiple dose trial with HuMax-IL8 in patients with metastatic or unresectable, locally advanced malignant solid tumors.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bristol-Myers Squibb
• Collaborator: This trial was conducted previously by Cormorant

Criteria

Inclusion Criteria:

• Subjects must have metastatic or unresectable locally advanced malignant solid tumor.

• Patients may have measurable or non-measurable but evaluable disease.

• Patients with surgically resected metastatic disease at high risk of relapse are also eligible.

• Patients must have completed or had disease progression on at least one prior line of disease-appropriate therapy for metastatic disease, or not be candidates for therapy of proven efficacy for their disease.

• Patients must have recovered (grade 1 or baseline) from any clinically significant toxicity associated with prior therapy

• Age ≥ 18 years. .

• ECOG (Eastern Cooperative Oncology Group) performance status ≤ 1 (Karnofsky ≥ 70%).

• Patients must have normal organ and hematologic function therapy

• Patients must have baseline pulse oximetry > 90% on room air

Exclusion Criteria:

• Pregnant women or women presently breast-feeding

• Concurrent treatment for cancer

• Chronic hepatitis B or C infection.

• Any significant disease that, in the opinion of the investigator, may impair the patient's tolerance of study treatment.

• Significant dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent.

• Active autoimmune diseases requiring treatment or a history of autoimmune disease.

• Concurrent use of systemic steroids

• Patients who are receiving any other investigational agents

• Patients with untreated central nervous system metastases or local treatment of brain metastases

• History of allergic reactions attributed to compounds of similar chemical or biologic composition to the agent used in study.

• Serious or uncontrolled intercurrent illness

• HIV-positive patients are ineligible

• Patients unwilling to use adequate contraception

Other protocol defined inclusion/exclusion criteria could apply