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

NCT02536469 | Completed Phase 1

• 2 other identifiers: COR01CD101CA027-001
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Solid Tumor

Outcome Measures

Primary Outcomes (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.

  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

  From cycle 1 day 1 up to 28 days

Secondary Outcomes (1)

• Pharmacokinetic properties of HuMax-IL8 in patients including AUC (Area Under the Curve)

  From baseline up to 72 hours after infusion

Study Arms (1)

HuMax-IL8

EXPERIMENTAL

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

Interventions

HuMax-IL8 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

Also known as: BMS-968253

HuMax-IL8

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

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

Study Sites (1)

National Cancer Institute

Bethesda, Maryland, 20892, United States

Location

Related Publications (1)

• Bilusic M, Heery CR, Collins JM, Donahue RN, Palena C, Madan RA, Karzai F, Marte JL, Strauss J, Gatti-Mays ME, Schlom J, Gulley JL. Phase I trial of HuMax-IL8 (BMS-986253), an anti-IL-8 monoclonal antibody, in patients with metastatic or unresectable solid tumors. J Immunother Cancer. 2019 Sep 5;7(1):240. doi: 10.1186/s40425-019-0706-x.

  PMID: 31488216 DERIVED

Related Links

• Investigator Inquiry Form

MeSH Terms

Interventions

HuMax-IL8

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2015
• First Posted: August 31, 2015
• Study Start: August 1, 2015
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2016
• Last Updated: February 3, 2017

Record last verified: 2017-02

Locations

US (1)