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A Phase I/Ib Study of NIZ985 Alone and in Combination With Spartalizumab

NCT04261439 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-05-06

No results posted yet for this study

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.

Conditions

  • In Escalation: All Patients With Solid Tumors and Lymphoma
  • In Expansion: Melanoma, Non-small Cell Lung Cancer

Interventions

DRUG

NIZ985

NIZ985 injection

DRUG

Spartalizumab

Spartalizumab infusion

DRUG

Tislelizumab

Tislelizumab infusion

Sponsors & Collaborators

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-02-27
Primary Completion
2023-12-27
Completion
2023-12-27
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • Germany
  • Italy
  • Japan
  • Spain
  • Taiwan

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04261439 on ClinicalTrials.gov