Study Stopped
A business decision was made to discontinue further enrollment. There were no safety concerns that contributed to this decision.
A Study of NM21-1480 in Adult Patients With Advanced Solid Tumors
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
2 other identifiers
interventional
52
3 countries
26
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Aug 2020
Typical duration for phase_1
26 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 18, 2020
CompletedFirst Posted
Study publicly available on registry
June 22, 2020
CompletedStudy Start
First participant enrolled
August 19, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 6, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
February 6, 2024
CompletedResults Posted
Study results publicly available
May 23, 2025
CompletedMay 23, 2025
May 1, 2025
3.5 years
June 18, 2020
February 5, 2025
May 7, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v5.0
Frequency and severity of adverse events
From baseline to up to 12 weeks post last dose, up to 48 weeks.
Maximum Tolerated Dose (MTD) of NM21-1480
To determine the MTD of NM21-1480 based on Part A. Note, No MTD was identified across all dose levels tested and a technical MTD was defined by the SMC as 800 mg following Part A, which was updated to 1400 mg by the SMC after completion of Part A-2.
Cycle 1 (28 days).
Determination of Phase 2 Dose of NM21-1480
To determine the recommended Phase 2 dose of NM21-1480 for Part B of the study
From baseline to up to 12 weeks post last dose, up to 48 weeks.
To Determine the Anti-tumor Activity (Best Overall Response) of NM21-1480 According to RECIST 1.1
For best overall response (BOR) and objective response rate (ORR), patients in the Efficacy Analysis Set (EAS) who did not have sufficient on-study tumor assessments to characterize response were included in the denominator when calculating BOR percent and ORR and were thus treated as non-responders.
From baseline to up to 12 weeks post last dose, up to 48 weeks.
Secondary Outcomes (13)
Assessment of the Maximum Observed Serum Concentration Determined by Direct Inspection of the Concentration Versus Time Data (Cmax)
From baseline to up to 12 weeks post last dose, up to 48 weeks.
Assessment of the the Minimum Observed Serum Concentration Determined by Direct Inspection of the Concentration Versus Time Data (Cmin)
From baseline to up to 12 weeks post last dose, up to 48 weeks.
Assessment of the Time From Dosing at Which Cmax is Apparent Determined by Direct Inspection of the Concentration Versus Time Data (Tmax)
From baseline to up to 12 weeks post last dose, up to 48 weeks.
Assessment of the Terminal Phase (Apparent Elimination) Rate Constant (λz)
From baseline to up to 12 weeks post last dose, up to 48 weeks.
Assessment of the Elimination Half-life (t½)
From baseline to up to 12 weeks post last dose, up to 48 weeks.
- +8 more secondary outcomes
Study Arms (1)
NM21-1480 Treatment arm
EXPERIMENTALInterventions
Trispecific anti-PD-L1/anti-4-1BB/anti-Human Serum Albumin (HSA) single-chain Fv fusion protein
Eligibility Criteria
You may qualify if:
- 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) or other protocol specified solid tumors with locally advanced or metastatic, non-resectable disease, which has progressed despite treatment with first-line standard of-care treatment, or first- and second-line treatment, dependent on expansion cohort.
- Prior therapy must have been completed 2-4 weeks prior to the administration of the first dose of study drug as specified per protocol according to type of prior therapy
You may not qualify if:
- Patient previously had known immediate or delayed hypersensitivity reaction or idiosyncrasy to the excipients
- Part A: 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: As defined per protocol for each expansion cohort, has not been treated with specified first/second-line standard-of-care therapies biological drugs (marketed or investigational) for treatment of the current cancer, or has not adequately recovered from AEs that occurred with prior therapy.
- Patient has an active autoimmune disease or a documented history of autoimmune disease.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (26)
UCHealth Poudre Valley Hospital
Fort Collins, Colorado, 80524, United States
Augusta University Medical Center
Augusta, Georgia, 30912, United States
Tulane University Medical Center
New Orleans, Louisiana, 70112, United States
Henry Ford Health System
Detroit, Michigan, 48202, United States
St. Joseph Mercy Hospital
Ypsilanti, Michigan, 48197, United States
Dartmouth Cancer Center
Lebanon, New Hampshire, 03766, United States
NYU Langone Medical Center - Perlmutter Cancer Center (NYU Cancer Institute)
New York, New York, 10016, United States
Montefiore Medical Center
The Bronx, New York, 10461-2374, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107, United States
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232, United States
Medical University of South Carolina (MUSC)
Charleston, South Carolina, 29425, United States
Sarah Cannon Cancer Center
Nashville, Tennessee, 37203, United States
The University Of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
Virginia Cancer Specialists
Fairfax, Virginia, 22031, United States
Hospital Universitario de A Coruna
A Coruña, Spain
Hospital Universitario Vall dHebron
Barcelona, Spain
Hospital General Universitario de Elche
Elche, Spain
Complejo Hospitalario de Jaen
Jaén, Spain
Centro Integral Oncologico Clara Campal
Madrid, Spain
Clinica Universidad de Navarra - Madrid
Madrid, Spain
Hospital Universitario Virgen de la Victoria
Málaga, Spain
Hospital Universitario Son Llatzer
Palma de Mallorca, Spain
Clinica Universidad de Navarra - Pamplona
Pamplona, Spain
Hospital Universitario Virgen Macarena
Seville, Spain
Hospital Universitari i Politecnic La Fe
Valencia, Spain
National Taiwan University Hospital
Taipei, Taiwan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Josephine Adams
- Organization
- Numab Therapeutics AG
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 18, 2020
First Posted
June 22, 2020
Study Start
August 19, 2020
Primary Completion
February 6, 2024
Study Completion
February 6, 2024
Last Updated
May 23, 2025
Results First Posted
May 23, 2025
Record last verified: 2025-05