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HuMax-IL8

Phase 1

Solid Tumor | Small molecule | Oncology |Bristol-Myers Squibb Company|Last Updated: Feb 3, 2017

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment15

FDA Designations

No designations recorded

Clinical trial landscape

HuMax-IL8 · 1 trial · 1 indication

Phase 1 1
NCT02536469HuMax-IL8 (Interleukin8) in Patients With Advanced Malignant Solid TumorsSolid Tumor
COMPLETED15 Analytics
PHASE1COMPLETED
HuMax-IL8 (Interleukin8) in Patients With Advanced Malignant Solid Tumors
Solid TumorUnlock trial analytics

Study Endpoints

Primary Endpoints

Proportion of patients who experience DLTs (Dose Limiting Toxicity) 28 days following the first dose of HuMax-IL8, as well as all DLTs occurring during the study thereafter.
From cycle 1 day 1 up to 28 days

The primary endpoint of this study is the proportion of patients who experience DLTs. The MTD (Maximum Tolerated Dose) will be determined based on the dose escalation cohorts. The evaluation period for DLTs will be 28 days following the first dose of HuMax-IL8

Secondary Endpoints

Pharmacokinetic properties of HuMax-IL8 in patients including AUC (Area Under the Curve)
From baseline up to 72 hours after infusion
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
HuMax-IL8EXPERIMENTALHuMax-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

NameTypeDescription
HuMax-IL8DRUGHuMax-IL8 drug product intended for intravenous infusion. Subjects will be treated every 2 weeks. Every 2 doses (4 weeks) will be considered 1 cycle
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

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 ...

Countries:United States
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Competitive Landscape -Other Solid Tumors 9 trials (matched to "Solid Tumor")

Frequently asked questions about HuMax-IL8

What is HuMax-IL8 used for?

HuMax-IL8 is an investigational drug being studied for the treatment of solid tumors. It is currently in Phase 1 clinical development for this indication. The drug is being evaluated in patients with advanced malignant solid tumors.

What does HuMax-IL8 target?

HuMax-IL8 targets interleukin-8 (IL-8), a cytokine involved in tumor progression and inflammation. By targeting IL-8, the drug aims to interfere with the tumor microenvironment and potentially inhibit tumor growth. This mechanism is being explored in the context of solid tumor oncology.

Who makes HuMax-IL8?

HuMax-IL8 is being developed by Bristol-Myers Squibb Company, a biopharmaceutical company listed on the New York Stock Exchange under the ticker symbol BMY. The company is conducting clinical research on this drug for the treatment of solid tumors.

What phase is HuMax-IL8 in?

HuMax-IL8 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The Phase 1 trial has been completed, and the drug is still in the early stages of clinical evaluation for solid tumors.

What clinical trials is HuMax-IL8 in?

HuMax-IL8 has one completed clinical trial registered under NCT02536469, titled "HuMax-IL8 (Interleukin8) in Patients With Advanced Malignant Solid Tumors." This Phase 1 study enrolled 15 participants in the United States and was an uncontrolled, non-randomized trial.