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

JRCT ID: jRCT2080225081

Registered date:20/02/2020

Basic Information

• Recruitment status: completed
• Health condition(s) or Problem(s) studied: advanced solid tumors and lymphoma
• Date of first enrollment: 29/02/2020
• Target sample size: 12
• Countries of recruitment: Japan,North America,Europe
• Study type: Interventional

Intervention(s)

Arm 1: Single agent arm. NIZ985 is administered as a single agent (subjects may be treated with the NIZ985-Spartalizumab combination after their first disease re-evaluation).
Arm 2: Combination arm. NIZ985 and Spartalizumab combination is administered starting at Cycle 1 Day 1 in dose escalation. NIZ985 and tislelizumab combination is administered starting at Cycle 1 Day 1 in dose expansion.

Outcome(s)

Primary Outcome

safety
Incidence of Dose Limiting Toxicities in Cycle 1 (28 days) for NIZ985 as a single agent and in combination with spartalizumab

Secondary Outcome

efficacy
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.

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include 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.

Exclude 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.

Related Information

• Primary Sponsor: Novartis Pharma. K.K.
• Source(s) of Monetary Support: -
• Secondary ID(s): NCT04261439,JapicCTI-205176