A Phase I/Ib Study of NIZ985 Alone and in Combination With Spartalizumab (NCT04261439) | Clinical Trial Compass
TerminatedPhase 1
A Phase I/Ib Study of NIZ985 Alone and in Combination With Spartalizumab
Stopped: Sponsor's decision and not due to any safety concerns
United States, Belgium, Germany60 participantsStarted 2020-02-27
Plain-language summary
The purpose of this phase I/Ib study was to determine the safety profile of NIZ985 (new formulation), and if it could be safely combined with spartalizumab or tislelizumab and to determine the appropriate dose and schedule for further study. Moreover, the study characterized the pharmacokinetic profiles of NIZ985 as a single agent and in combination with spartalizumab or tislelizumab and identified preliminary anti-tumor activity.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Signed informed consent must be obtained prior to participation in the study.
✓. Male or female patients ≥ 18 years of age
✓. Histologically confirmed and documented advanced solid tumors and lymphoma (includes locally advanced malignancies that are not curable by surgery or radiotherapy, and those with metastatic disease) with documented progression following standard therapy, and for whom, no standard therapy is available, tolerated or appropriate. Disease must be measurable as determined by RECIST 1.1 (refer to Appendix 1) or Cheson et al (2014) (refer to Appendix 6).
✓. Patients must be willing and able to comply with the protocol for the duration of the study
✓. Patients must have a site of disease amenable to biopsy and be a candidate for tumor biopsy according to the treating institution's guidelines. Patient must be willing to undergo a new tumor biopsy at screening and during therapy on the study.
✓. ECOG performance status ≤1 and in the opinion of the investigator, likely to complete at least 28 days of treatment.
Exclusion criteria
✕. Patients that have received any prior IL-15 treatment.
What they're measuring
1
Incidence of Dose Limiting Toxcities (DLTs) in escalation and expansion
Timeframe: 1 cycle (28 days)
2
Number of patients with and severity of adverse events (AEs) and serious adverse events (SAEs)
✕. History of severe hypersensitivity reactions to any ingredient of study drug(s) and other mAbs and/or their excipients. In addition, patients with a history of immune mediated toxicities from CPI that led to permanent discontinuation of CPI treatment will be excluded.
✕. Patients with primary CNS tumors are excluded. Presence of symptomatic CNS metastases, or CNS metastases that require local CNS-directed therapy (such as radiotherapy or surgery), or increasing doses of corticosteroids 2 weeks prior to study entry. Patients with treated symptomatic brain metastases should be neurologically stable (for 4 weeks post-treatment and prior to study entry) and at a dose of ≤ 10 mg per day prednisone or equivalent for at least 2 weeks before administration of any study treatment.
✕. Systemic chronic steroid therapy (\> 10mg/day prednisone or equivalent) or any immunosuppressive therapy, other than replacement-dose steroids in the setting of adrenal insufficiency, within 7 days of the first dose of study treatment. Topical, inhaled, nasal and ophthalmic steroids are allowed.
✕. Malignant disease, other than that being treated in this study, that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer or other tumors that will not affect life expectancy.
✕. Patients having out of range lab values during screening and before the first dose of study treatment. Out of range lab values are defined as:
✕. Impaired cardiovascular function or clinically significant cardiovascular disease, including any of the following: