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

A Phase Ib, Dose Escalation, Multiple Dose Trial With HuMax-IL8 in Patients With Metastatic or Unresectable, Locally Advanced Malignant Solid Tumors

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

Study Overview

• Status: Completed
• Conditions: Solid Tumor
• Intervention / Treatment: Drug: HuMax-IL8

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 Type: Interventional
• Enrollment (Actual): 15
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Bethesda, Maryland, United States, 20892
      • National Cancer Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
Pharmacokinetic properties of HuMax-IL8 in patients including AUC (Area Under the Curve)	From baseline up to 72 hours after infusion

Collaborators and Investigators

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

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: August 1, 2015
• Primary Completion (Actual): November 1, 2016
• Study Completion (Actual): November 1, 2016

Study Registration Dates

• First Submitted: August 23, 2015
• First Submitted That Met QC Criteria: August 28, 2015
• First Posted (Estimate): August 31, 2015

Study Record Updates

• Last Update Posted (Estimate): February 3, 2017
• Last Update Submitted That Met QC Criteria: February 1, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: COR01CD101; CA027-001 (Other Identifier: BMS)