NCT04442126 · REGISTRY CONDITION SEARCH

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

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: PHASE1, PHASE2
Status at capture: TERMINATED
Registry last update: 2025-05-23

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v5.0

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outcome · POSTED

Maximum Tolerated Dose (MTD) of NM21-1480

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outcome · POSTED

Determination of Phase 2 Dose of NM21-1480

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outcome · POSTED

To Determine the Anti-tumor Activity (Best Overall Response) of NM21-1480 According to RECIST 1.1

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outcome · POSTED

Assessment of the Maximum Observed Serum Concentration Determined by Direct Inspection of the Concentration Versus Time Data (Cmax)

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outcome · POSTED

Assessment of the the Minimum Observed Serum Concentration Determined by Direct Inspection of the Concentration Versus Time Data (Cmin)

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outcome · POSTED

Assessment of the Time From Dosing at Which Cmax is Apparent Determined by Direct Inspection of the Concentration Versus Time Data (Tmax)

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outcome · POSTED

Assessment of the Terminal Phase (Apparent Elimination) Rate Constant (λz)

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outcome · POSTED

Assessment of the Elimination Half-life (t½)

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outcome · POSTED

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])

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outcome · POSTED

Assessment of the Area Under Serum Concentration-time Curve Over Dosing Interval (AUCtau)

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outcome · POSTED

Assessment of the Clearance (CL)

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outcome · POSTED

Assessment of the Volume of Distribution (Vd)

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outcome · POSTED

Assessment of the Frequency of Specific Anti-drug Antibodies to NM21-1480

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outcome · POSTED

To Determine the Anti-tumor Activity (Duration of Response) of NM21-1480 According to RECIST 1.1

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outcome · POSTED

To Determine the Anti-tumor Activity (Time-to-response) of NM21-1480 According to RECIST 1.1

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outcome · POSTED

To Determine the Anti-tumor Activity (Progression-free Survival) of NM21-1480 According to RECIST 1.1

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

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.
healthy Volunteers: false
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

intervention Names
Biological: NM21-1480
label
NM21-1480 Treatment arm
type
EXPERIMENTAL

interventions

arm Group Labels
NM21-1480 Treatment arm
description
Trispecific anti-PD-L1/anti-4-1BB/anti-Human Serum Albumin (HSA) single-chain Fv fusion protein
name
NM21-1480
type
BIOLOGICAL

Study design

allocation

intervention Model

SEQUENTIAL

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 52
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
Frequency and severity of adverse events
measure
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.
description
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.
measure
Maximum Tolerated Dose (MTD) of NM21-1480
time Frame
Cycle 1 (28 days).
description
To determine the recommended Phase 2 dose of NM21-1480 for Part B of the study
measure
Determination of Phase 2 Dose of NM21-1480
time Frame
From baseline to up to 12 weeks post last dose, up to 48 weeks.
description
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.
measure
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.

secondary Outcomes

measure
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.
measure
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.
measure
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.
measure
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.
measure
Assessment of the Elimination Half-life (t½)
time Frame
From baseline to up to 12 weeks post last dose, up to 48 weeks.
measure
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.
measure
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.
measure
Assessment of the Clearance (CL)
time Frame
From baseline to up to 12 weeks post last dose, up to 48 weeks.
measure
Assessment of the Volume of Distribution (Vd)
time Frame
From baseline to up to 12 weeks post last dose, up to 48 weeks.
measure
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.
measure
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.
measure
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.

Full study description

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.

Source references

references

citation
Johansson MU, Kerschenmeyer A, Carella A, Carnal S, Schmidt Y, de Felice A, Mahler D, Thomas M, Spiga FM, Tietz J, Weinert C, Hess C, Urech D, Warmuth S. Structure-guided design of antibody CDRs to reduce their reactivity to treatment-emergent anti-drug antibodies. MAbs. 2026 Dec;18(1):2604353. doi: 10.1080/19420862.2025.2604353. Epub 2025 Dec 22.
pmid
41424175
type
DERIVED

Source notices and limitations

Discovery and provenance

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ctgov-registry-1336d216cbd1bbff780dac70
edge id
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exact text
NCT04442126
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query cond
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query disease state id
ds-small-intestine-cancer
source file
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source kind
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source string sha256
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source url
https://clinicaltrials.gov/api/v2/studies?query.cond=Small+Intestine+Cancer&filter.advanced=AREA%5BHasResults%5Dtrue&pageSize=1000&format=json&countTotal=true

Preserved source evidence · Not medical advice