A Study of NM21-1480 in Adult Patients With Advanced Solid Tumors
Megadott ok: A business decision was made to discontinue further enrollment. There were no safety concerns that contributed to this decision.
Key facts
- Where
- Augusta, Charleston, Detroit, Fairfax, Fort Collins, Houston, Lebanon, Nashville, New Orleans, New York, Philadelphia, Pittsburgh, The Bronx és Ypsilanti, Egyesült ÁllamokSee the 14 sites
- Phase
- 1/2. fázis
Where in Egyesült Államok
- Augusta University Medical CenterAugusta, Egyesült ÁllamokNo longer taking part
- Medical University of South Carolina (MUSC)Charleston, Egyesült ÁllamokNo longer taking part
- Henry Ford Health SystemDetroit, Egyesült ÁllamokNo longer taking part
- Virginia Cancer SpecialistsFairfax, Egyesült ÁllamokNo longer taking part
- UCHealth Poudre Valley HospitalFort Collins, Egyesült ÁllamokNo longer taking part
- The University of Texas MD Anderson Cancer CenterHouston, Egyesült ÁllamokNo longer taking part
- Dartmouth Cancer CenterLebanon, Egyesült ÁllamokNo longer taking part
- Sarah Cannon Cancer CenterNashville, Egyesült ÁllamokNo longer taking part
- Tulane University Medical CenterNew Orleans, Egyesült ÁllamokNo longer taking part
- NYU Langone Medical Center - Perlmutter Cancer Center (NYU Cancer Institute)New York, Egyesült ÁllamokNo longer taking part
- Thomas Jefferson UniversityPhiladelphia, Egyesült ÁllamokNo longer taking part
- UPMC Hillman Cancer CenterPittsburgh, Egyesült ÁllamokNo longer taking part
- Montefiore Medical CenterThe Bronx, Egyesült ÁllamokNo longer taking part
- St. Joseph Mercy HospitalYpsilanti, Egyesült ÁllamokNo longer taking part
Trial details
- Who runs it
- Numab Therapeutics AG
- Trial code
- NCT04442126
- Record updated
- 2025. május 23.
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: 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.
Exclusion: Patient previously had known immediate or delayed hypersensitivity reaction or idiosyncrasy to the excipients; 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; 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.