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

Bristol-Myers Squibb (BMS)

Status and phase

Completed

Phase 1

Conditions

Solid Tumor

Treatments

Drug: HuMax-IL8

Study type

Interventional

Funder types

Industry

Other

Identifiers

NCT02536469

CA027-001 (Other Identifier)

COR01CD101

Details and patient eligibility

About

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

Full description

All human subjects with a diagnosis of incurable solid tumors are eligible for the dose-escalation phase of this study. This study consists of two phases, the dose-escalation phase and the expansion phase. Subjects will be treated with the study treatment until any off-treatment criteria are met. The safety and efficacy will be assessed until the end of treatment or for a maximum of 52 weeks. In addition, a separate visit will be performed at the time of disease progression if the patient has a progression between end of treatment and 52 weeks. The patients will be followed up for overall survival until the study closure. The study will be closed when all enrolled patients have been followed up for at least 52 weeks or have died.

Enrollment

15 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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