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

Completed · Phase 1

Conditions studied: Solid Tumor

In brief

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

Key facts

Study ID

NCT02536469

Run by

Bristol-Myers Squibb

People needed

15

Starts

2015-08-01

Expected to finish

2016-11-01

Last updated by the study team

2017-02-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• National Cancer Institute — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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