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

Sponsor
Bristol-Myers Squibb (Industry)
Overall Status
Completed
CT.gov ID
NCT02536469
Collaborator
This trial was conducted previously by Cormorant (Other)
15
Enrollment
1
Location
1
Arm
15
Duration (Months)
1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 1

Detailed 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.

Study Design

Study Type:
Interventional
Actual Enrollment :
15 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase Ib, Dose Escalation, Multiple Dose Trial With HuMax-IL8 in Patients With Metastatic or Unresectable, Locally Advanced Malignant Solid Tumors
Study Start Date :
Aug 1, 2015
Actual Primary Completion Date :
Nov 1, 2016
Actual Study Completion Date :
Nov 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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

Drug: 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
Other Names:
  • BMS-968253

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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 Outcome Measures

    1. Pharmacokinetic properties of HuMax-IL8 in patients including AUC (Area Under the Curve) [From baseline up to 72 hours after infusion]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 National Cancer Institute Bethesda Maryland United States 20892

    Sponsors and Collaborators

    • Bristol-Myers Squibb
    • This trial was conducted previously by Cormorant

    Investigators

    • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Bristol-Myers Squibb
    ClinicalTrials.gov Identifier:
    NCT02536469
    Other Study ID Numbers:
    • COR01CD101
    • CA027-001
    First Posted:
    Aug 31, 2015
    Last Update Posted:
    Feb 3, 2017
    Last Verified:
    Feb 1, 2017
    Additional relevant MeSH terms:
    Neoplasms

    Study Results

    No Results Posted as of Feb 3, 2017