Clinical trial · Interventional
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
NCT02536469CI-TRIAL-00025773completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
A phase Ib, dose escalation, multiple dose trial with HuMax-IL8 in patients with metastatic or unresectable, locally advanced malignant solid tumors.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| HuMax-IL8 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- HuMax-IL8
- description
- 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
- interventionNames
- Drug: HuMax-IL8
Primary outcomes (1)
- measure
- 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.
- timeFrame
- From cycle 1 day 1 up to 28 days
- description
- 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 outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDBilusic 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