Clinical Trials List
Protocol NumberNB-ND021(NM21-1480)-101
NCT Number(ClinicalTrials.gov Identfier)NCT04442126
2021-11-16 - 2024-02-06
Phase I/II
Not yet recruiting2
Recruiting1
A Phase 1/2 Study of NM21-1480 (Anti-PDL-1/Anti-4-1BB/Anti-HSA Tri-Specific Antibody) in Adult Patients With Advanced Solid Tumors
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Trial Applicant
MEDPACE TAIWAN LIMITED
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Sponsor
Numab Therapeutics AG
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Trial scale
Multi-Regional Multi-Center
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Update
2025/08/20
Investigators and Locations
Co-Principal Investigator
- Jih-Hsiang Lee Division of Hematology & Oncology
- JIN-YUAN SHIH Division of Hematology & Oncology
- 許嘉林 Division of Hematology & Oncology
- YEN-TING LIN Division of Hematology & Oncology
- 廖斌志 Division of Hematology & Oncology
- 陳冠宇 Division of Hematology & Oncology
- 蔡子修 Division of Hematology & Oncology
- 徐偉勛 Division of Hematology & Oncology
- CHAO-CHI HO CHAO-CHI HO Division of Hematology & Oncology
- 楊景堯 Division of Hematology & Oncology
- Chia-Chi Lin Division of Hematology & Oncology
- Chong-Jen Yu Division of Hematology & Oncology
- 廖唯昱 Division of Hematology & Oncology
- 吳尚俊 Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Chi-Lu Chiang Division of Thoracic Medicine
- Tien-Hua Chen Division of Hematology & Oncology
- 陳盛裕 Division of Hematology & Oncology
- Muh-Hwa Yang Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Co-Principal Investigator
- 陳鴻仁 Division of Thoracic Medicine
- Yu-Chao Lin Division of Thoracic Medicine
- Chia-Hsiang Li Division of Thoracic Medicine
- Chih-Yen Tu Division of Thoracic Medicine
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Condition/Disease
Advanced Solid Tumors
Objectives
This is a first-in-human, open-label, multi-center, Phase 1/2, dose-escalation study with expansion cohorts to evaluate NM21-1480 for safety and immunogenicity, to determine the maximal tolerated dose and recommended Phase 2 dose, define the pharmacokinetics, to explore the pharmacodynamics, and to obtain preliminary evidence of the clinical activity in adult patients with selected advanced solid tumors.
Test Drug
NM21-1480
Active Ingredient
NM21-1480
Dosage Form
Vialed solution
Dosage
100mg/10mL
Endpoints
Primary Outcome Measures :
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 [ Time Frame: Up to 3 years ]
Frequency and severity of adverse events
Maximum Tolerated Dose (MTD) of NM21-1480 [ Time Frame: Up to 3 years ]
To determine the MTD of NM21-1480
Determination of Phase 2 dose of NM21-1480 [ Time Frame: Up to 3 years ]
To determine the recommended Phase 2 dose of NM21-1480 for Part B of the study
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 [ Time Frame: Up to 3 years ]
Frequency and severity of adverse events
Maximum Tolerated Dose (MTD) of NM21-1480 [ Time Frame: Up to 3 years ]
To determine the MTD of NM21-1480
Determination of Phase 2 dose of NM21-1480 [ Time Frame: Up to 3 years ]
To determine the recommended Phase 2 dose of NM21-1480 for Part B of the study
Inclution Criteria
Inclusion Criteria:
Part A
Patients with any previously treated solid tumor-type other than hepatocellular carcinoma or intrahepatic cholangiocarcinoma that is advanced, or recurrent and progressing since last anti-tumor therapy, and for which no alternative, standard therapy exists.
Prior chemotherapy, radiation therapy or immunotherapy must have been completed at least 4 weeks prior to the administration of the first dose of study drug, and patient has recovered
Part B:
Patients with Non Small Cell Lung Cancer (NSCLC), Squamous Cell Cancer Head and Neck (SCCHN) and basket cohort consisting of melanoma, gastric or gastro-esophageal junction adenocarcinoma, renal cell carcinoma or urothelial carcinoma with locally advanced or metastatic, non-resectable disease, which has progressed despite treatment with anti-programmed cell death protein (anti-PD-1) or anti-programmed death-ligand 1 (anti-PD-L1) monotherapy or anti-PD1/chemotherapy or anti-PD-L1/chemotherapy
Prior therapy must have been completed at least 4 weeks prior to the administration of the first dose of study drug.
Part A
Patients with any previously treated solid tumor-type other than hepatocellular carcinoma or intrahepatic cholangiocarcinoma that is advanced, or recurrent and progressing since last anti-tumor therapy, and for which no alternative, standard therapy exists.
Prior chemotherapy, radiation therapy or immunotherapy must have been completed at least 4 weeks prior to the administration of the first dose of study drug, and patient has recovered
Part B:
Patients with Non Small Cell Lung Cancer (NSCLC), Squamous Cell Cancer Head and Neck (SCCHN) and basket cohort consisting of melanoma, gastric or gastro-esophageal junction adenocarcinoma, renal cell carcinoma or urothelial carcinoma with locally advanced or metastatic, non-resectable disease, which has progressed despite treatment with anti-programmed cell death protein (anti-PD-1) or anti-programmed death-ligand 1 (anti-PD-L1) monotherapy or anti-PD1/chemotherapy or anti-PD-L1/chemotherapy
Prior therapy must have been completed at least 4 weeks prior to the administration of the first dose of study drug.
Exclusion Criteria
Exclusion Criteria:
Patient previously had known immediate or delayed hypersensitivity reaction or idiosyncrasy to the excipients
Treatment with any PD-1, or Cytotoxic T-Lymphocyte Associated Protein (CTLA)-4 directed antibody or with any other immunotherapy within 4 weeks prior to initiation of the study drug.
Part A: Use of other biological investigational drugs (drugs not marketed for any indication), including use of investigational drugs targeting CD137/4-1BB within at least 5 half-lives (or within 8 weeks, whatever is longer) prior to the administration of the first dose of study drug.
Part B: Use of other biological drugs (marketed or investigational) for treatment of the current cancer other than anti-PD1, anti-PD-L1, or anti-CTLA-4 directed antibodies.
Patient has an active autoimmune disease or a documented history of autoimmune disease.
Patient previously had known immediate or delayed hypersensitivity reaction or idiosyncrasy to the excipients
Treatment with any PD-1, or Cytotoxic T-Lymphocyte Associated Protein (CTLA)-4 directed antibody or with any other immunotherapy within 4 weeks prior to initiation of the study drug.
Part A: Use of other biological investigational drugs (drugs not marketed for any indication), including use of investigational drugs targeting CD137/4-1BB within at least 5 half-lives (or within 8 weeks, whatever is longer) prior to the administration of the first dose of study drug.
Part B: Use of other biological drugs (marketed or investigational) for treatment of the current cancer other than anti-PD1, anti-PD-L1, or anti-CTLA-4 directed antibodies.
Patient has an active autoimmune disease or a documented history of autoimmune disease.
The Estimated Number of Participants
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Taiwan
31 participants
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Global
405 participants
