A phase I/Ib study of NIZ985 alone and in combination with Spartalizumab

Phase 1

Completed

• Conditions: advanced solid tumors and lymphoma

• Registration Number: JPRN-jRCT2080225081
• Lead Sponsor: ovartis Pharma. K.K.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-02-20
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: completed
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

1. Histologically confirmed and documented advanced solid tumors and lymphoma (includes locally advanced that are not curable by surgery or radiotherapy, and those with metastatic disease) with documented progression following standard therapy, or for whom, no appropriate standard therapy exists.
2. Patients must have a site of disease amenable to biopsy and be a candidate for tumor biopsy according to the treating institution guidelines. the patient must be willing to undergo a new tumor biopsy at screening and during treatment.

Exclusion Criteria

1. Patients that have received any prior IL-15 treatment.
2. 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.
3. Malignant disease, other than that being treated in this study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
safety<br>Incidence of Dose Limiting Toxicities in Cycle 1 (28 days) for NIZ985 as a single agent and in combination with spartalizumab

Secondary Outcome Measures

Name	Time	Method
efficacy<br>anti-tumor activity per RECIST v1.1, iRECIST or lymphoma response criteria (Cheson et al 2014). Serum concentration of NIZ985 and spartalizumab and derived PK parameters.