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A Safety and Tolerability Study of NC410 in Subjects With Advanced or Metastatic Solid Tumors
Phase 1, PHASE2 trial testing NC410 in Advanced or Metastatic Solid Tumors in 46 participants. Terminated before completion.
| Lead sponsor | NextCure, Inc. |
|---|---|
| Phase | Phase 1, PHASE2 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | sequential |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 46 |
| Start date | 10 June 2020 |
| Primary completion | 6 July 2023 |
| Estimated completion | 6 July 2023 |
| Sites | 5 locations across United States |
NextCure, Inc. — full company profile →
18 and older, any sex, with Advanced or Metastatic Solid Tumors or Ovarian Cancer. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of Participants With Treatment-emergent Adverse Events
| Group | Value | 95% CI |
|---|---|---|
| NC410 3mg | 3 | |
| NC410 6mg | 3 | |
| NC410 15mg | 4 | |
| NC410 30mg | 9 | |
| NC410 60mg | 10 | |
| NC410 100mg | 9 | |
| NC410 200mg | 6 |
To assess antitumor activity/efficacy by evaluating objective response rate (ORR), defined as the percentage of participants who experienced a complete response (CR; disappearance of all target lesions) or a partial response (PR; at least a 30% decrease in the sum of diameters of target lesions) based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
| Group | Value | 95% CI |
|---|---|---|
| NC410 3mg | 0 | |
| NC410 6mg | 0 | |
| NC410 15mg | 0 | |
| NC410 30mg | 0 | |
| NC410 60mg | 0 | |
| NC410 100mg | 0 | |
| NC410 200mg | 0 |
To assess antitumor activity/efficacy by evaluating duration of response (DoR), defined as the time from the first documented complete response or partial response per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or Modified Response Evaluation Criteria in Solid Tumors to the first documented progressive disease or death due to any cause, whichever occurs first. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT or MRI: CompleteResponse (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in t
| Group | Value | 95% CI |
|---|---|---|
| NC410 3mg | NA | NA – NA |
| NC410 6mg | NA | NA – NA |
| NC410 15mg | NA | NA – NA |
| NC410 30mg | NA | NA – NA |
| NC410 60mg | NA | NA – NA |
| NC410 100mg | NA | NA – NA |
| NC410 200mg | NA | NA – NA |
To assess antitumor activity/efficacy by evaluating disease control rate (DCR), defined as the proportion of participants in whom a documented complete response, partial response, or stable disease is observed as the best overall response per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
| Group | Value | 95% CI |
|---|---|---|
| NC410 3mg | 1 | |
| NC410 6mg | 3 | |
| NC410 15mg | 1 | |
| NC410 30mg | 1 | |
| NC410 60mg | 1 | |
| NC410 100mg | 1 | |
| NC410 200mg | 1 |
To evaluate the Maximum Plasma Concentration (Cmax) of NC410
| Group | Value | 95% CI |
|---|---|---|
| NC410 15mg | NA | ± NA |
| NC410 30mg | 754 | ± 295 |
| NC410 60mg | 2801 | ± 1102 |
| NC410 100mg | 5296 | ± 4405 |
| NC410 200mg | 11665 | ± 9821 |
| Group | Value | 95% CI |
|---|---|---|
| NC410 15mg | 443 | ± NA |
| NC410 30mg | 1490 | ± 184 |
| NC410 60mg | 2200 | ± NA |
| NC410 100mg | 2220 | ± NA |
| NC410 200mg | 2880 | ± NA |
To evaluate progression-free survival (PFS), defined as the time from the first dose of NC410 to the first occurrence of documented progressive disease or death due to any cause, whichever occurs first. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), asa 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions .
| Group | Value | 95% CI |
|---|---|---|
| NC410 3mg | 1.7 | 1.6 – NA |
| NC410 6mg | 3.6 | 3.6 – NA |
| NC410 15mg | 1.3 | 0.5 – NA |
| NC410 30mg | 1.7 | 1.0 – 3.5 |
| NC410 60mg | 1.4 | 1.0 – 1.7 |
| NC410 100mg | 1.4 | 1.2 – 1.8 |
| NC410 200mg | 1.8 | 1.2 – NA |
To evaluate overall survival (OS), defined as the time from the first dose of NC410 to death due to any cause.
| Group | Value | 95% CI |
|---|---|---|
| NC410 3mg | NA | 7.6 – NA |
| NC410 6mg | 5.3 | 4.1 – NA |
| NC410 15mg | NA | NA – NA |
| NC410 30mg | NA | 1.4 – NA |
| NC410 60mg | 4.8 | 1.0 – NA |
| NC410 100mg | NA | 1.3 – NA |
| NC410 200mg | NA | 1.2 – NA |
To evaluate the Area Under the Curve (AUC) of NC410.
| Group | Value | 95% CI |
|---|---|---|
| NC410 30mg | 13528 | ± 15259 |
| NC410 60mg | 64530 | ± 38613 |
| NC410 100mg | 107591 | ± 52432 |
| NC410 200mg | 263894 | ± 121831 |
| Group | Value | 95% CI |
|---|---|---|
| NC410 15mg | 1056 | ± NA |
| NC410 30mg | 47324 | ± 3674 |
| NC410 60mg | 41448 | ± NA |
| NC410 100mg | 205493 | ± NA |
| NC410 200mg | 260199 | ± NA |
To evaluate the half-life (t1/2) of NC410
| Group | Value | 95% CI |
|---|---|---|
| NC410 30mg | 75.7 | ± 74.7 |
| NC410 60mg | 126 | ± 52.0 |
| NC410 100mg | 173 | ± 43.6 |
| NC410 200mg | 111 | ± 53.8 |
| Group | Value | 95% CI |
|---|---|---|
| NC410 30mg | 138 | ± 7.23 |
| NC410 60mg | 41.1 | ± NA |
| NC410 100mg | 156 | ± NA |
| NC410 200mg | 194 | ± NA |
Time frame: From enrollment through up to 90 days after end of treatment, an average of 1 year.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | NC410 3mg | NC410 6mg | NC410 15mg | NC410 30mg | NC410 60mg | NC410 100mg | NC410 200mg |
|---|---|---|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | — | — | — | — | — | — | — |
| Cardiac arrest | Cardiac disorders | — | — | — | — | — | — | — |
| Abdominal pain | Gastrointestinal disorders | — | — | — | — | — | — | — |
| Abdominal pain upper | Gastrointestinal disorders | — | — | — | — | — | — | — |
| Ascites | Gastrointestinal disorders | — | — | — | — | — | — | — |
| Pancreatitis | Gastrointestinal disorders | — | — | — | — | — | — | — |
| Small intestinal obstruction | Gastrointestinal disorders | — | — | — | — | — | — | — |
| Disease Progression | General disorders | — | — | — | — | — | — | — |
| Non-cardiac chest pain | General disorders | — | — | — | — | — | — | — |
| Biliary obstruction | Hepatobiliary disorders | — | — | — | — | — | — | — |
| Cholangitis acute | Hepatobiliary disorders | — | — | — | — | — | — | — |
| Cholecystitis acute | Hepatobiliary disorders | — | — | — | — | — | — | — |
| Hepatic Haemorrhage | Hepatobiliary disorders | — | — | — | — | — | — | — |
| Infusion Related Hypersensitivity reaction | Immune system disorders | — | — | — | — | — | — | — |
| Sepsis | Infections and infestations | — | — | — | — | — | — | — |
| Urinary tract infection | Infections and infestations | — | — | — | — | — | — | — |
| Fall | Injury, poisoning and procedural complications | — | — | — | — | — | — | — |
| Hip Fracture | Injury, poisoning and procedural complications | — | — | — | — | — | — | — |
| Failure to Thrive | Metabolism and nutrition disorders | — | — | — | — | — | — | — |
| Arthralgia | Musculoskeletal and connective tissue disorders | — | — | — | — | — | — | — |
| Colorectal Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — | — | — | — | — | — | — |
| Cerebral Ischaemia | Nervous system disorders | — | — | — | — | — | — | — |
| Encephalopathy | Nervous system disorders | — | — | — | — | — | — | — |
| Acute Kidney Injury | Renal and urinary disorders | — | — | — | — | — | — | — |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | — | — | — | — | — | — | — |
| Reaction | System | NC410 3mg | NC410 6mg | NC410 15mg | NC410 30mg | NC410 60mg | NC410 100mg | NC410 200mg |
|---|---|---|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | — | — | — | — | — | — | — |
| Constipation | Gastrointestinal disorders | — | — | — | — | — | — | — |
| Nausea | Gastrointestinal disorders | — | — | — | — | — | — | — |
| Hypokalaemia | Metabolism and nutrition disorders | — | — | — | — | — | — | — |
| Dizziness | Nervous system disorders | — | — | — | — | — | — | — |
| Leukocytosis | Blood and lymphatic system disorders | — | — | — | — | — | — | — |
| Abdominal pain | Gastrointestinal disorders | — | — | — | — | — | — | — |
| Vomiting | Gastrointestinal disorders | — | — | — | — | — | — | — |
| Urinary tract infection | Infections and infestations | — | — | — | — | — | — | — |
| Alanine aminotransferase increased | Investigations | — | — | — | — | — | — | — |
| Aspartate aminotransferase increased | Investigations | — | — | — | — | — | — | — |
| Hyponatraemia | Metabolism and nutrition disorders | — | — | — | — | — | — | — |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | — | — | — | — | — | — | — |
| Ascites | Gastrointestinal disorders | — | — | — | — | — | — | — |
| Fatigue | General disorders | — | — | — | — | — | — | — |
| Non-cardiac chest pain | General disorders | — | — | — | — | — | — | — |
| Pyrexia | General disorders | — | — | — | — | — | — | — |
| Chills | General disorders | — | — | — | — | — | — | — |
| Infusion related reaction | Injury, poisoning and procedural complications | — | — | — | — | — | — | — |
| Blood creatinine increased | Investigations | — | — | — | — | — | — | — |
| Lipase increased | Investigations | — | — | — | — | — | — | — |
| Blood alkaline phosphatase increased | Investigations | — | — | — | — | — | — | — |
| Weight decreased | Investigations | — | — | — | — | — | — | — |
| White blood cell count decreased | Investigations | — | — | — | — | — | — | — |
| Electrocardiogram QT prolonged | Investigations | — | — | — | — | — | — | — |
| Hyperuricaemia | Metabolism and nutrition disorders | — | — | — | — | — | — | — |
| Hypomagnesaemia | Metabolism and nutrition disorders | — | — | — | — | — | — | — |
| Dehydration | Metabolism and nutrition disorders | — | — | — | — | — | — | — |
| Back pain | Musculoskeletal and connective tissue disorders | — | — | — | — | — | — | — |
| Pain in extremity | Musculoskeletal and connective tissue disorders | — | — | — | — | — | — | — |
| Headache | Nervous system disorders | — | — | — | — | — | — | — |
| Haematuria | Renal and urinary disorders | — | — | — | — | — | — | — |
| Cough | Respiratory, thoracic and mediastinal disorders | — | — | — | — | — | — | — |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | — | — | — | — | — | — | — |
| Hypotension | Vascular disorders | — | — | — | — | — | — | — |
| Thrombocytopenia | Blood and lymphatic system disorders | — | — | — | — | — | — | — |
| Lymphopenia | Blood and lymphatic system disorders | — | — | — | — | — | — | — |
| Cardiac arrest | Cardiac disorders | — | — | — | — | — | — | — |
| Conduction disorder | Cardiac disorders | — | — | — | — | — | — | — |
| Sinus bradycardia | Cardiac disorders | — | — | — | — | — | — | — |
Most-reported serious reactions: Anaemia, Cardiac arrest, Abdominal pain, Abdominal pain upper, Ascites, Pancreatitis, Small intestinal obstruction, Disease Progression.
Data from ClinicalTrials.gov NCT04408599 adverse events section.
This research study is studying a new drug, NC410, as a possible treatment for advanced or metastatic solid tumors.
8 peer-reviewed publications reference this trial (live from Europe PMC):
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Currently open trials in the same condition.
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Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04408599.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing