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

Phase 1

Terminated

• Conditions: Ovarian Carcinoma; Head and Neck Squamous Cell Carcinoma; Triple Negative Breast Cancer; Advanced Solid Tumor; Colorectal Cancer; Fallopian Tube Cancer; Non-small Cell Lung Cancer; Squamous Cell Carcinoma; Peritoneal Carcinoma
• Interventions: Biological: NM21-1480

• Registration Number: NCT04442126
• Lead Sponsor: Numab Therapeutics AG

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-06-18
• Study First Submitted QC: 2020-06-19
• Study First Posted: 2020-06-22
• Study Start: 2020-08-19
• Status Verified: 2024-02
• Primary Completion: 2024-02-06
• Study Completion: 2024-02-06
• Last Update Submitted: 2024-02-26
• Last Update Posted: 2024-02-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 52

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
NM21-1480 Treatment arm	NM21-1480	-

Primary Outcome Measures

Name	Time	Method
Determination of Phase 2 dose of NM21-1480	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	Up to 3 years	Frequency and severity of adverse events
Maximum Tolerated Dose (MTD) of NM21-1480	Up to 3 years	To determine the MTD of NM21-1480
To determine the anti-tumor activity (Best Overall Response) of NM21-1480 according to RECIST 1.1	Up to 3 years
To determine the anti-tumor activity (Overall Response Rate) of NM21-1480 according to RECIST 1.1	Up to 3 years

Secondary Outcome Measures

Name	Time	Method
To determine the anti-tumor activity (Overall Survival) of NM21-1480 according to RECIST 1.1	Up to 3 years
To determine the anti-tumor activity (Disease Control Rate) of NM21-1480 according to RECIST 1.1	Up to 3 years
To determine the anti-tumor activity (Time-to-response) of NM21-1480 according to RECIST 1.1	Up to 3 years
To determine the anti-tumor activity (Progression-free survival) of NM21-1480 according to RECIST 1.1	Up to 3 years
Assessment of the the minimum observed serum concentration determined by direct inspection of the concentration versus time data (Cmin)	Up to 3 years
Assessment of the elimination half-life (t½)	Up to 3 years
Assessment of the frequency of specific anti-drug antibodies to NM21-1480	Up to 3 years
To determine the anti-tumor activity (Duration of Response) of NM21-1480 according to RECIST 1.1	Up to 3 years
Assessment of the time from dosing at which Cmax is apparent determined by direct inspection of the concentration versus time data (Tmax)	Up to 3 years
Assessment of the maximum observed serum concentration determined by direct inspection of the concentration versus time data (Cmax)	Up to 3 years
Assessment of the terminal phase (apparent elimination) rate constant (λz)	Up to 3 years
Assessment of the area under the serum concentration-time curve extrapolated from the last quantifiable concentration to infinity (AUC[0-infinity])	Up to 3 years
Assessment of the area under serum concentration-time curve over dosing interval (AUCtau)	Up to 3 years
Assessment of the volume of distribution (Vd)	Up to 3 years
Assessment of the clearance (CL)	Up to 3 years

Trial Locations

Locations (26)

The University Of Texas MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States

Virginia Cancer Specialists; 🇺🇸 Fairfax, Virginia, United States

Augusta University Medical Center; 🇺🇸 Augusta, Georgia, United States

Tulane University Medical Center; 🇺🇸 New Orleans, Louisiana, United States

Hospital Universitario de A Coruna; 🇪🇸 A Coruña, Spain

Medical University of South Carolina (MUSC); 🇺🇸 Charleston, South Carolina, United States

Dartmouth Cancer Center; 🇺🇸 Lebanon, New Hampshire, United States

UCHealth Poudre Valley Hospital; 🇺🇸 Fort Collins, Colorado, United States

St. Joseph Mercy Hospital; 🇺🇸 Ypsilanti, Michigan, United States

Hospital Universitario Vall dHebron; 🇪🇸 Barcelona, Spain

UPMC Hillman Cancer Center; 🇺🇸 Pittsburgh, Pennsylvania, United States

NYU Langone Medical Center - Perlmutter Cancer Center (NYU Cancer Institute); 🇺🇸 New York, New York, United States

Hospital General Universitario de Elche; 🇪🇸 Elche, Spain

Hospital Universitario Virgen Macarena; 🇪🇸 Sevilla, Spain

Hospital Universitario Son Llatzer; 🇪🇸 Palma De Mallorca, Spain

Centro Integral Oncologico Clara Campal; 🇪🇸 Madrid, Spain

Clinica Universidad de Navarra - Pamplona; 🇪🇸 Pamplona, Spain

Complejo Hospitalario de Jaen; 🇪🇸 Jaén, Spain

Hospital Universitario Virgen de la Victoria; 🇪🇸 Málaga, Spain

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan

Hospital Universitari i Politecnic La Fe; 🇪🇸 Valencia, Spain

Clinica Universidad de Navarra - Madrid; 🇪🇸 Madrid, Spain

Henry Ford Health System; 🇺🇸 Detroit, Michigan, United States

Sarah Cannon Cancer Center; 🇺🇸 Nashville, Tennessee, United States

Montefiore Medical Center; 🇺🇸 Bronx, New York, United States

Thomas Jefferson University; 🇺🇸 Philadelphia, Pennsylvania, United States