TriangleNCT04442126 · STUDY IN CONTEXT
A Study of NM21-1480 in Adult Patients With Advanced Solid Tumors
Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
Read the full study record and all posted results →
Linked outcomes
Frequency and severity of adverse events
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.
To determine the recommended Phase 2 dose of NM21-1480 for Part B of the study
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.
Assessment of the Maximum Observed Serum Concentration Determined by Direct Inspection of the Concentration Versus Time Data (Cmax)
Assessment of the the Minimum Observed Serum Concentration Determined by Direct Inspection of the Concentration Versus Time Data (Cmin)
Reported safety
Quality of life and patient-reported measures
No linked quality-of-life measure is recorded for this setting and study.
Full draft applicability and source-link record
- trial
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-peritoneal-neoplasm
- nct id
- NCT04442126
- trial label
- A Study of NM21-1480 in Adult Patients With Advanced Solid Tumors
- applicability
- narrower
- applicability note
- Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- provenance class
- registry-condition-search
- discovery note
- Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
- outcome Count
- 6
- harms Count
- 9
- qol Count
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-peritoneal-neoplasm
- nct id
- NCT04442126
- outcome key
- om-0000
- source section id
- NCT04442126-om-0000
- source outcome index
- 0
- endpoint
- Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v5.0
- endpoint definition
- Frequency and severity of adverse events
- time origin
- From baseline to up to 12 weeks post last dose, up to 48 weeks.
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Participant with any TREA
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-peritoneal-neoplasm
- nct id
- NCT04442126
- outcome key
- om-0001
- source section id
- NCT04442126-om-0001
- source outcome index
- 1
- endpoint
- Maximum Tolerated Dose (MTD) of NM21-1480
- endpoint definition
- 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.
- time origin
- Cycle 1 (28 days).
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- MTD of NM21-1480 based on Part A and part A2. 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.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-peritoneal-neoplasm
- nct id
- NCT04442126
- outcome key
- om-0002
- source section id
- NCT04442126-om-0002
- source outcome index
- 2
- endpoint
- Determination of Phase 2 Dose of NM21-1480
- endpoint definition
- To determine the recommended Phase 2 dose of NM21-1480 for Part B of the study
- time origin
- From baseline to up to 12 weeks post last dose, up to 48 weeks.
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-peritoneal-neoplasm
- nct id
- NCT04442126
- outcome key
- om-0003
- source section id
- NCT04442126-om-0003
- source outcome index
- 3
- endpoint
- To Determine the Anti-tumor Activity (Best Overall Response) of NM21-1480 According to RECIST 1.1
- endpoint definition
- 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.
- time origin
- From baseline to up to 12 weeks post last dose, up to 48 weeks.
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- The ORR for each given group (dose level, cohort, or arm) in the EAS are summarized according to RECIST 1.1 (and according to iRECIST), accompanied by a 2-sided exact 95% Clopper-Pearson confidence interval (CI).
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-peritoneal-neoplasm
- nct id
- NCT04442126
- outcome key
- om-0004
- source section id
- NCT04442126-om-0004
- source outcome index
- 4
- endpoint
- Assessment of the Maximum Observed Serum Concentration Determined by Direct Inspection of the Concentration Versus Time Data (Cmax)
- endpoint definition
- Assessment of the Maximum Observed Serum Concentration Determined by Direct Inspection of the Concentration Versus Time Data (Cmax)
- time origin
- From baseline to up to 12 weeks post last dose, up to 48 weeks.
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Cmax determined at C1 for all dose levels with the exception of Part A Dose Level 1 which has been noted as NA ,for which was BLQ. Lower limit of quantification (LLOQ) of NM21-1480 = 5 ng/mL.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-peritoneal-neoplasm
- nct id
- NCT04442126
- outcome key
- om-0005
- source section id
- NCT04442126-om-0005
- source outcome index
- 5
- endpoint
- Assessment of the the Minimum Observed Serum Concentration Determined by Direct Inspection of the Concentration Versus Time Data (Cmin)
- endpoint definition
- Assessment of the the Minimum Observed Serum Concentration Determined by Direct Inspection of the Concentration Versus Time Data (Cmin)
- time origin
- From baseline to up to 12 weeks post last dose, up to 48 weeks.
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Cmin determined at C1 for all dose levels with the exception of Part A Dose Level 1 which has been noted as NA ,for which was BLQ. Note: Lower limit of quantification (LLOQ) of NM21-1480 = 5 ng/mL.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- arms
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-peritoneal-neoplasm
- nct id
- NCT04442126
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Part A Dose Level 1 NM21-1490-Q2W 0.15mg
- regimen
- Part A Dose Level 1 NM21-1490-Q2W 0.15mg
- analyzed count
- 1
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT04442126-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-peritoneal-neoplasm
- nct id
- NCT04442126
- outcome key
- om-0000
- arm key
- OG001
- arm label
- Part A Dose Level 2 NM21-1490-Q2W 1.5mg
- regimen
- Part A Dose Level 2 NM21-1490-Q2W 1.5mg
- analyzed count
- 1
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT04442126-om-0000#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-peritoneal-neoplasm
- nct id
- NCT04442126
- outcome key
- om-0000
- arm key
- OG002
- arm label
- Part A Dose Level 3 NM21-1490-Q2W 8mg
- regimen
- Part A Dose Level 3 NM21-1490-Q2W 8mg
- analyzed count
- 3
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT04442126-om-0000#groups/OG002
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-peritoneal-neoplasm
- nct id
- NCT04442126
- outcome key
- om-0000
- arm key
- OG003
- arm label
- Part A Dose Level 4 NM21-1490-Q2W 24mg
- regimen
- Part A Dose Level 4 NM21-1490-Q2W 24mg
- analyzed count
- 3
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT04442126-om-0000#groups/OG003
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-peritoneal-neoplasm
- nct id
- NCT04442126
- outcome key
- om-0000
- arm key
- OG004
- arm label
- Part A Dose Level 5 NM21-1490-Q2W 80mg
- regimen
- Part A Dose Level 5 NM21-1490-Q2W 80mg
- analyzed count
- 6
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT04442126-om-0000#groups/OG004
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-peritoneal-neoplasm
- nct id
- NCT04442126
- outcome key
- om-0000
- arm key
- OG005
- arm label
- Part A Dose Level 6 NM21-1490-Q2W 240mg
- regimen
- Part A Dose Level 6 NM21-1490-Q2W 240mg
- analyzed count
- 3
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT04442126-om-0000#groups/OG005
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-peritoneal-neoplasm
- nct id
- NCT04442126
- outcome key
- om-0000
- arm key
- OG006
- arm label
- Part A Dose Level 7 NM21-1490-Q2W 800mg
- regimen
- Part A Dose Level 7 NM21-1490-Q2W 800mg
- analyzed count
- 9
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT04442126-om-0000#groups/OG006
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-peritoneal-neoplasm
- nct id
- NCT04442126
- outcome key
- om-0000
- arm key
- OG007
- arm label
- Part A2 NM32-1480-Q2W
- regimen
- Part A2 NM32-1480-Q2W 1400mg
- analyzed count
- 5
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT04442126-om-0000#groups/OG007
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-peritoneal-neoplasm
- nct id
- NCT04442126
- outcome key
- om-0000
- arm key
- OG008
- arm label
- Part B NM32-1480-Q2W
- regimen
- Part B NM32-1480-Q2W 800mg
- analyzed count
- 21
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT04442126-om-0000#groups/OG008
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-peritoneal-neoplasm
- nct id
- NCT04442126
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Part A Dose Level 1 NM21-1480-Q2W 0.15mg
- regimen
- Part A Dose Level 1 NM21-1480-Q2W 0.15mg
- analyzed count
- 0
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT04442126-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-peritoneal-neoplasm
- nct id
- NCT04442126
- outcome key
- om-0001
- arm key
- OG001
- arm label
- Part A Dose Level 2 NM21-1480-Q2W 1.5mg
- regimen
- Part A Dose Level 2 NM21-1480-Q2W 1.5mg
- analyzed count
- 0
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT04442126-om-0001#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-peritoneal-neoplasm
- nct id
- NCT04442126
- outcome key
- om-0001
- arm key
- OG002
- arm label
- Part A Dose Level 3 NM21-1480-Q2W 8mg
- regimen
- Part A Dose Level 3 NM21-1480-Q2W 8mg
- analyzed count
- 0
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT04442126-om-0001#groups/OG002
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-peritoneal-neoplasm
- nct id
- NCT04442126
- harm key
- EG000
- source section id
- NCT04442126-ae
- event group key
- EG000
- event group label
- Part A Dose Level 1 NM21-1480-Q2W 0.15mg
- serious affected
- 0
- serious at risk
- 1
- other affected
- 1
- other at risk
- 1
- frequency threshold
- 5
- collection period
- Up to 3 years.
- event definition
- The safety population included all participants enrolled in the study who received at least one dose of study treatment.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-peritoneal-neoplasm
- nct id
- NCT04442126
- harm key
- EG001
- source section id
- NCT04442126-ae
- event group key
- EG001
- event group label
- Part A Dose Level 2 NM21-1480-Q2W 1.5mg
- serious affected
- 1
- serious at risk
- 1
- other affected
- 1
- other at risk
- 1
- frequency threshold
- 5
- collection period
- Up to 3 years.
- event definition
- The safety population included all participants enrolled in the study who received at least one dose of study treatment.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-peritoneal-neoplasm
- nct id
- NCT04442126
- harm key
- EG002
- source section id
- NCT04442126-ae
- event group key
- EG002
- event group label
- Part A Dose Level 3 NM21-1480-Q2W 8mg
- serious affected
- 1
- serious at risk
- 3
- other affected
- 3
- other at risk
- 3
- frequency threshold
- 5
- collection period
- Up to 3 years.
- event definition
- The safety population included all participants enrolled in the study who received at least one dose of study treatment.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-peritoneal-neoplasm
- nct id
- NCT04442126
- harm key
- EG003
- source section id
- NCT04442126-ae
- event group key
- EG003
- event group label
- Part A Dose Level 4 NM21-1480-Q2W 24mg
- serious affected
- 1
- serious at risk
- 3
- other affected
- 3
- other at risk
- 3
- frequency threshold
- 5
- collection period
- Up to 3 years.
- event definition
- The safety population included all participants enrolled in the study who received at least one dose of study treatment.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-peritoneal-neoplasm
- nct id
- NCT04442126
- harm key
- EG004
- source section id
- NCT04442126-ae
- event group key
- EG004
- event group label
- Part A Dose Level 5 NM21-1480-Q2W 80mg
- serious affected
- 2
- serious at risk
- 6
- other affected
- 5
- other at risk
- 6
- frequency threshold
- 5
- collection period
- Up to 3 years.
- event definition
- The safety population included all participants enrolled in the study who received at least one dose of study treatment.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-peritoneal-neoplasm
- nct id
- NCT04442126
- harm key
- EG005
- source section id
- NCT04442126-ae
- event group key
- EG005
- event group label
- Part A Dose Level 6 NM21-1480-Q2W 240mg
- serious affected
- 1
- serious at risk
- 3
- other affected
- 3
- other at risk
- 3
- frequency threshold
- 5
- collection period
- Up to 3 years.
- event definition
- The safety population included all participants enrolled in the study who received at least one dose of study treatment.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-peritoneal-neoplasm
- nct id
- NCT04442126
- harm key
- EG006
- source section id
- NCT04442126-ae
- event group key
- EG006
- event group label
- Part A Dose Level 7 NM21-1480-Q2W 800mg
- serious affected
- 4
- serious at risk
- 9
- other affected
- 9
- other at risk
- 9
- frequency threshold
- 5
- collection period
- Up to 3 years.
- event definition
- The safety population included all participants enrolled in the study who received at least one dose of study treatment.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-peritoneal-neoplasm
- nct id
- NCT04442126
- harm key
- EG007
- source section id
- NCT04442126-ae
- event group key
- EG007
- event group label
- Part A2 NM21-1480-Q2W
- serious affected
- 3
- serious at risk
- 5
- other affected
- 5
- other at risk
- 5
- frequency threshold
- 5
- collection period
- Up to 3 years.
- event definition
- The safety population included all participants enrolled in the study who received at least one dose of study treatment.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-peritoneal-neoplasm
- nct id
- NCT04442126
- harm key
- EG008
- source section id
- NCT04442126-ae
- event group key
- EG008
- event group label
- Part B NM21-1480-Q2W
- serious affected
- 6
- serious at risk
- 21
- other affected
- 16
- other at risk
- 21
- frequency threshold
- 5
- collection period
- Up to 3 years.
- event definition
- The safety population included all participants enrolled in the study who received at least one dose of study treatment.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- quality of life
- setting source links
Preserved source evidence · Not medical advice