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

May 7, 2025 updated by: Numab Therapeutics AG

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
52

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Spain
      • A Coruña, Spain
        • Hospital Universitario de A Coruña
      • Barcelona, Spain
        • Hospital Universitario Vall Dhebron
      • Elche, Spain
        • Hospital General Universitario de Elche
      • Jaén, Spain
        • Complejo Hospitalario de Jaén
      • Madrid, Spain
        • Centro Integral Oncologico Clara Campal
      • Madrid, Spain
        • Clinica Universidad de Navarra - Madrid
      • Málaga, Spain
        • Hospital Universitario Virgen de la Victoria
      • Palma De Mallorca, Spain
        • Hospital Universitario Son Llàtzer
      • Pamplona, Spain
        • Clinica Universidad de Navarra - Pamplona
      • Sevilla, Spain
        • Hospital Universitario Virgen Macarena
      • Valencia, Spain
        • Hospital Universitari i Politecnic La Fe
  • Taiwan
      • Taipei, Taiwan
        • National Taiwan University Hospital
  • United States
    • Colorado
      • Fort Collins, Colorado, United States, 80524
        • UCHealth Poudre Valley Hospital
    • Georgia
      • Augusta, Georgia, United States, 30912
        • Augusta University Medical Center
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • Tulane University Medical Center
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Health System
      • Ypsilanti, Michigan, United States, 48197
        • St. Joseph Mercy Hospital
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03766
        • Dartmouth Cancer Center
    • New York
      • Bronx, New York, United States, 10461-2374
        • Montefiore Medical Center
      • New York, New York, United States, 10016
        • NYU Langone Medical Center - Perlmutter Cancer Center (NYU Cancer Institute)
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson University
      • Pittsburgh, Pennsylvania, United States, 15232
        • UPMC Hillman Cancer Center
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina (MUSC)
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Sarah Cannon Cancer Center
    • Texas
      • Houston, Texas, United States, 77030
        • The University of Texas MD Anderson Cancer Center
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Virginia Cancer Specialists

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: NM21-1480 Treatment arm
Biological: NM21-1480
Trispecific anti-PD-L1/anti-4-1BB/anti-Human Serum Albumin (HSA) single-chain Fv fusion protein

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v5.0
Time Frame: From baseline to up to 12 weeks post last dose, up to 48 weeks.
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
Time Frame: Cycle 1 (28 days).
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
Time Frame: From baseline to up to 12 weeks post last dose, up to 48 weeks.
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
Time Frame: From baseline to up to 12 weeks post last dose, up to 48 weeks.
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Assessment of the Maximum Observed Serum Concentration Determined by Direct Inspection of the Concentration Versus Time Data (Cmax)
Time Frame: From baseline to up to 12 weeks post last dose, up to 48 weeks.
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)
Time Frame: From baseline to up to 12 weeks post last dose, up to 48 weeks.
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)
Time Frame: From baseline to up to 12 weeks post last dose, up to 48 weeks.
From baseline to up to 12 weeks post last dose, up to 48 weeks.
Assessment of the Terminal Phase (Apparent Elimination) Rate Constant (λz)
Time Frame: From baseline to up to 12 weeks post last dose, up to 48 weeks.
From baseline to up to 12 weeks post last dose, up to 48 weeks.
Assessment of the Elimination Half-life (t½)
Time Frame: From baseline to up to 12 weeks post last dose, up to 48 weeks.
From baseline to up to 12 weeks post last dose, up to 48 weeks.
Assessment of the Area Under the Serum Concentration-time Curve Extrapolated From the Last Quantifiable Concentration to Infinity Quantifiable Concentration to Infinity (AUC[0-infinity])
Time Frame: From baseline to up to 12 weeks post last dose, up to 48 weeks.
From baseline to up to 12 weeks post last dose, up to 48 weeks.
Assessment of the Area Under Serum Concentration-time Curve Over Dosing Interval (AUCtau)
Time Frame: From baseline to up to 12 weeks post last dose, up to 48 weeks.
From baseline to up to 12 weeks post last dose, up to 48 weeks.
Assessment of the Clearance (CL)
Time Frame: From baseline to up to 12 weeks post last dose, up to 48 weeks.
From baseline to up to 12 weeks post last dose, up to 48 weeks.
Assessment of the Volume of Distribution (Vd)
Time Frame: From baseline to up to 12 weeks post last dose, up to 48 weeks.
From baseline to up to 12 weeks post last dose, up to 48 weeks.
Assessment of the Frequency of Specific Anti-drug Antibodies to NM21-1480
Time Frame: From baseline to up to 12 weeks post last dose, up to 48 weeks.
From baseline to up to 12 weeks post last dose, up to 48 weeks.
To Determine the Anti-tumor Activity (Duration of Response) of NM21-1480 According to RECIST 1.1
Time Frame: From baseline to up to 12 weeks post last dose, up to 48 weeks.
From baseline to up to 12 weeks post last dose, up to 48 weeks.
To Determine the Anti-tumor Activity (Time-to-response) of NM21-1480 According to RECIST 1.1
Time Frame: From baseline to up to 12 weeks post last dose, up to 48 weeks.
From baseline to up to 12 weeks post last dose, up to 48 weeks.
To Determine the Anti-tumor Activity (Progression-free Survival) of NM21-1480 According to RECIST 1.1
Time Frame: From baseline to up to 12 weeks post last dose, up to 48 weeks.
From baseline to up to 12 weeks post last dose, up to 48 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Numab Therapeutics AG

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 19, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 6, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 6, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 18, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 19, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 22, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 23, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 7, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NB-ND021 (NM21-1480)-101
  • 2020-0355 (Other Identifier: MDACC Protocol ID)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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