HuMax-IL8 (Interleukin8) in Patients With Advanced Malignant 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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-31

Study Completion Date

2016-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Ipilimumab With or Without Vaccine Therapy in Treating Patients With Previously Treated Stage IV Melanoma

NCT00357461

Melanoma (Skin)

WITHDRAWN PHASE2

Cytokine-induced Killer Study for Patients With Stage II Melanoma

NCT02498756

Melanoma

NOT_YET_RECRUITING PHASE2

Vaccine Combining Multiple Class I Peptides and Montanide ISA 51VG With Escalating Doses of Anti-PD-1 Antibody Nivolumab or Ipilimumab With Nivolumab For Patients With Resected Stages IIIC/ IV Melanoma

NCT01176474

Melanoma (Skin)

COMPLETED PHASE1

Monoclonal Antibody With or Without gp100 Peptides Plus Montanide ISA-51 in Treating Patients With Stage IV Melanoma

NCT00077532

Melanoma (Skin)

COMPLETED PHASE2

HV-101 for Patients With Advanced Solid Tumors

NCT05868915

Advanced Solid Tumors

TERMINATED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Solid Tumor

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

HuMax-IL8

HuMax-IL8 drug product intended for intravenous infusion. Subjects will be treated every 2 weeks. Every 2 doses (4 weeks) will be considered 1 cycle

Group Type EXPERIMENTAL

HuMax-IL8

Intervention Type DRUG

HuMax-IL8 drug product intended for intravenous infusion. Subjects will be treated every 2 weeks. Every 2 doses (4 weeks) will be considered 1 cycle

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

HuMax-IL8

HuMax-IL8 drug product intended for intravenous infusion. Subjects will be treated every 2 weeks. Every 2 doses (4 weeks) will be considered 1 cycle

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

BMS-968253

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No