Clinical Trials List
Protocol NumberCNIS793X2101
NCT Number(ClinicalTrials.gov Identfier)NCT02947165
2017-05-01 - 2020-12-31
Phase I
Terminated1
ICD-9199.0
Disseminated malignant neoplasm
A phase I/Ib, open-label, multi-center dose escalation study of NIS793 in combination with PDR001 in adult patients with advanced malignancies
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Trial Applicant
NOVARTIS (TAIWAN) CO., LTD.
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Sponsor
Novartis Pharmaceuticals
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Trial scale
Multi-Regional Multi-Center
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Update
2025/08/20
Investigators and Locations
Co-Principal Investigator
- Chiun Hsu Division of Hematology & Oncology
- 廖唯昱 Division of Hematology & Oncology
- Ann-Lii Cheng Division of Hematology & Oncology
- Chih-Hung Hsu Division of Hematology & Oncology
- CHAO-CHI HO CHAO-CHI HO Division of Hematology & Oncology
- 廖斌志 Division of Hematology & Oncology
- James Chih-Hsin Yang Division of Hematology & Oncology
- Wei-Wu Chen Division of Hematology & Oncology
- 張端瑩 Division of Hematology & Oncology
- Chong-Jen Yu Division of Hematology & Oncology
- 徐偉勛 Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Terminated
Audit
None
Condition/Disease
Advanced Solid Tumors
Objectives
The purpose of this “first-in-human” study of NIS793 is to characterize the safety, tolerability, pharmacokinetics (PK), pharmacodynamics and antitumor activity of NIS793 administered i.v. as a single agent and in combination with PDR001 in adult patients with advanced solid tumors.
Test Drug
NIS793, PDR001
Active Ingredient
NIS793
PDR001
PDR001
Dosage Form
powder for solution for infusion
powder for solution for infusion
powder for solution for infusion
Dosage
100mg/vial
100mg/vial
100mg/vial
Endpoints
To characterize the safety and tolerability of NIS793 as single agent and in combination with PDR001 and to identify recommended doses for future studies
Inclution Criteria
Inclusion criteria (selected)
1. Written informed consent must be obtained prior to any screening procedures
2. Patient (male or female) ≥ 18 years of age
3. Escalation: Patients with advanced/metastatic solid tumors, with measurable or non-measurable disease as determined by RECIST version 1.1, who have progressed despite standard therapy or are intolerant of standard therapy, or for whom no standard therapy exists.
4. Expansion: Patients with advanced/metastatic solid tumors, with at least one measurable lesion as determined by RECIST version 1.1, who have progressed despite standard therapy following their last prior therapy or are intolerant to standard therapy and fit into one of the following groups: Group 1: NSCLC; Group 2: TNBC; Group 3: HCC; Group 4: MSS-CRC; Group 5: pancreatic, prostate and ccRCC
5. ECOG Performance Status ≤ 2.
6. Patients must have a site of disease amenable to biopsy, and be a candidate for tumor biopsy. Patient must be willing to undergo a new tumor biopsy at screening, and during therapy on this study. Exceptions may be made on a case by case basis after documented discussion with Novartis.
1. Written informed consent must be obtained prior to any screening procedures
2. Patient (male or female) ≥ 18 years of age
3. Escalation: Patients with advanced/metastatic solid tumors, with measurable or non-measurable disease as determined by RECIST version 1.1, who have progressed despite standard therapy or are intolerant of standard therapy, or for whom no standard therapy exists.
4. Expansion: Patients with advanced/metastatic solid tumors, with at least one measurable lesion as determined by RECIST version 1.1, who have progressed despite standard therapy following their last prior therapy or are intolerant to standard therapy and fit into one of the following groups: Group 1: NSCLC; Group 2: TNBC; Group 3: HCC; Group 4: MSS-CRC; Group 5: pancreatic, prostate and ccRCC
5. ECOG Performance Status ≤ 2.
6. Patients must have a site of disease amenable to biopsy, and be a candidate for tumor biopsy. Patient must be willing to undergo a new tumor biopsy at screening, and during therapy on this study. Exceptions may be made on a case by case basis after documented discussion with Novartis.
Exclusion Criteria
Exclusion criteria (selected)
1. History of severe hypersensitivity reactions to study treatment ingredients or other monoclonal antibodies and components of study drug
2. Patients with active, known or suspected autoimmune disease. Note: Patients with vitiligo, type I diabetes mellitus, residual hypothyroidism only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.
3. HIV infection.
4. Active HBV or HCV infection.
1. History of severe hypersensitivity reactions to study treatment ingredients or other monoclonal antibodies and components of study drug
2. Patients with active, known or suspected autoimmune disease. Note: Patients with vitiligo, type I diabetes mellitus, residual hypothyroidism only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.
3. HIV infection.
4. Active HBV or HCV infection.
The Estimated Number of Participants
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Taiwan
20 participants
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Global
154 participants
