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Monoclonal Antibodies

NC318 for Solid Tumors

Phase 1 & 2
Waitlist Available
Research Sponsored by NextCure, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 1 year
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new drug, NC318, to see if it can shrink solid tumors.

Eligible Conditions
  • Advanced or Metastatic Solid Tumors
  • Breast Cancer
  • Colorectal Cancer
  • Bile Duct Cancer
  • Bladder Cancer
  • Endometrial Cancer
  • Cholangiocarcinoma
  • Lung Cancer
  • Head and Neck Squamous Cell Carcinoma
  • Melanoma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of Participants With Treatment-emergent Adverse Events as Assessed by CTCAE v5.0
Secondary study objectives
Area Under the Curve (AUC) of NC318
Disease Control Rate (DCR) as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Duration of Response (DoR) as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
+5 more

Side effects data

From 2023 Phase 1 & 2 trial • 109 Patients • NCT03665285
31%
Anaemia
31%
Vomiting
23%
Nausea
23%
Hyponatraemia
15%
Fatigue
15%
Back pain
15%
Lipase increased
15%
Blood bilirubin increased
15%
Amylase increased
15%
Blood alkaline phosphatase increased
15%
Decreased appetite
15%
Constipation
15%
Aspartate aminotransferase increased
15%
Blood creatinine increased
8%
Blood calcium increased
8%
Dizziness
8%
Tumour Pain
8%
Haemoptysis
8%
Productive cough
8%
Extremity necrosis
8%
Bacteraemia
8%
Diarrhoea
8%
Insomnia
8%
Platelet count decreased
8%
Abdominal distension
8%
Abdominal pain UPPER
8%
Hypokalaemia
8%
Peripheral embolism
8%
Chills
8%
Oedema peripheral
8%
Abdominal pain lower
8%
Supraclavicular fossa pain
8%
Wound infection
8%
Infusion related reaction
8%
Alanine aminotransferase increased
8%
Acidosis
8%
Dyspnoea
8%
Hypercalcaemia
8%
Hyperphosphataemia
8%
Hyperkalaemia
8%
Myocardial infarction
8%
Hyperglycaemia
8%
Seizure
8%
Acute respiratory distress syndrome
8%
Hypothyroidism
8%
Abdominal pain
8%
Chest pain
8%
Pain
8%
Pyrexia
8%
Contusion
8%
Hypomagnesaemia
8%
Pain in extremity
8%
Peripheral sensory neuropathy
8%
Confusional state
8%
Hypoxia
8%
Dry skin
8%
Pruritus
8%
Rash
100%
80%
60%
40%
20%
0%
Study treatment Arm
Dose Expansion: 800mg QW
NC318 8mg
NC318 24mg
NC318 80mg
NC318 240mg
NC318 400mg
NC318 800mg
NC318 1600mg
Dose Expansion: 400mg Q2W

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

9Treatment groups
Experimental Treatment
Group I: NC318 8mgExperimental Treatment1 Intervention
Phase 1 Dose Escalation (Cohort -1): Subjects received NC318 IV at 8mg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first).
Group II: NC318 80mgExperimental Treatment1 Intervention
Phase 1 Dose Escalation/Safety Expansion (Cohort 2): Subjects received NC318 IV at 80mg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first).
Group III: NC318 800mgExperimental Treatment1 Intervention
Phase 1 Dose Escalation (Cohort 5): Subjects received NC318 IV at 800mg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first).
Group IV: NC318 400mgExperimental Treatment1 Intervention
Phase 1 Dose Escalation/Safety Expansion (Cohort 4): Subjects received NC318 IV at 400mg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first).
Group V: NC318 24mgExperimental Treatment1 Intervention
Phase 1 Dose Escalation (Cohort 1): Subjects received NC318 IV at 24mg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first).
Group VI: NC318 240mgExperimental Treatment1 Intervention
Phase 1 Dose Escalation/Safety Expansion (Cohort 3): Subjects received NC318 IV at 240mg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first).
Group VII: NC318 1600mgExperimental Treatment1 Intervention
Phase 1 Dose Escalation (Cohort 6): Subjects received NC318 IV at 1600mg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first).
Group VIII: Dose Expansion: 800mg QWExperimental Treatment1 Intervention
Phase 2 Dose Expansion (800mg): Subjects received NC318 IV at 800mg QW for 8 weeks, then Q2W thereafter until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first).
Group IX: Dose Expansion: 400mg Q2WExperimental Treatment1 Intervention
Phase 2 Dose Expansion (400mg): Subjects received NC318 IV at 400mg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
NC318
2018
Completed Phase 2
~110

Find a Location

Who is running the clinical trial?

NextCure, Inc.Lead Sponsor
6 Previous Clinical Trials
517 Total Patients Enrolled
Han Myint, MDStudy DirectorNextCure, Inc.
4 Previous Clinical Trials
358 Total Patients Enrolled
~15 spots leftby Nov 2025
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