A Study of NM21-1480 in Adult Patients With Advanced Solid Tumors

Numab Therapeutics

Status and phase

Terminated

Phase 2

Phase 1

Conditions

Squamous Cell Carcinoma

Non-small Cell Lung Cancer

Advanced Solid Tumor

Ovarian Carcinoma

Fallopian Tube Cancer

Triple Negative Breast Cancer

Peritoneal Carcinoma

Head and Neck Squamous Cell Carcinoma

Colorectal Cancer

Treatments

Biological: NM21-1480

Study type

Interventional

Funder types

Industry

Identifiers

NCT04442126

NB-ND021 (NM21-1480)-101

2020-0355 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

52 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.