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.
Title
- Brief Title: A Study of NM21-1480 in Adult Patients With Advanced Solid Tumors
- Official Title: 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
Clinical Trial IDs
- ORG STUDY ID:
NB-ND021 (NM21-1480)-101
- SECONDARY ID:
2020-0355
- NCT ID:
NCT04442126
Conditions
- Advanced Solid Tumor
- Non-small Cell Lung Cancer
Interventions
Drug | Synonyms | Arms |
---|
NM21-1480 | | NM21-1480 Treatment arm |
Purpose
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 Arms
Name | Type | Description | Interventions |
---|
NM21-1480 Treatment arm | Experimental | | |
Eligibility 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) 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 Criteria:
- 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.
Maximum Eligible Age: | 75 Years |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 |
Time Frame: | Up to 3 years |
Safety Issue: | |
Description: | Frequency and severity of adverse events |
Details
Phase: | Phase 1/Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Numab Therapeutics AG |
Trial Keywords
Last Updated
May 20, 2021