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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

Study Summary

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

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

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants With Treatment-emergent Adverse Events as Assessed by CTCAE v5.0
Secondary outcome measures
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
25%
Constipation
25%
Diarrhoea
25%
Pyrexia
25%
Anaemia
25%
Blood alkaline phosphatase increased
25%
Vomiting
25%
Nausea
17%
Infusion related reaction
17%
Pneumonia
17%
Abdominal distension
17%
Lymphocyte count decreased
17%
Dehydration
17%
Hypercalcaemia
17%
Aspartate aminotransferase increased
17%
Abdominal pain
17%
Fatigue
17%
Hypoalbuminaemia
17%
Blood bilirubin increased
17%
Hyponatraemia
17%
Pleural effusion
8%
Hypertension
8%
Weight increased
8%
Chromaturia
8%
Atrial fibrillation
8%
Extraocular muscle paresis
8%
Haemorrhoids
8%
Chills
8%
Non-cardiac chest pain
8%
Oedema peripheral
8%
Bile duct obstruction
8%
Bronchitis
8%
Amylase increased
8%
Blood creatinine increased
8%
Hypophosphataemia
8%
Headache
8%
Peripheral sensory neuropathy
8%
Tremor
8%
Confusional state
8%
Dysuria
8%
Cough
8%
Hyperhidrosis
8%
Rash maculo-papular
8%
Flushing
8%
Pericardial effusion
8%
Failure to thrive
8%
Back pain
8%
Respiratory failure
8%
Proctalgia
8%
Pathological fracture
8%
Acute respiratory failure
8%
Haemoptysis
8%
Oesophageal stenosis
8%
Diplopia
8%
Sinus tachycardia
8%
Influenza like illness
8%
Ascites
8%
Fall
8%
Alanine aminotransferase increased
8%
Hypocalcaemia
8%
Urinary tract infection
8%
Decreased appetite
8%
Transaminases increased
8%
Activated partial thromboplastin time prolonged
8%
Musculoskeletal pain
8%
Muscle spasms
8%
Oropharyngeal pain
8%
Productive cough
8%
Dizziness
8%
Hot flush
8%
Atelectasis
8%
Dyspnoea
100%
80%
60%
40%
20%
0%
Study treatment Arm
NC318 240mg
NC318 400mg
Dose Expansion: 400mg Q2W
NC318 24mg
NC318 8mg
NC318 80mg
NC318 800mg
NC318 1600mg
Dose Expansion: 800mg QW

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
439 Total Patients Enrolled
Han Myint, MDStudy DirectorNextCure, Inc.
4 Previous Clinical Trials
280 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are any additional participants being sought to participate in this experiment?

"Affirmative. According to the information on clinicaltrials.gov, this medical research is currently recruiting participants; it was posted originally on September 28th 2018 and modified most recently on August 17th 2022. A total of 187 patients are required between 9 locations for the trial to proceed."

Answered by AI

Are there any Canadian locations involved in the implementation of this trial?

"There are 9 trial sites that have opened enrollment for this study, including Luminis Health Anne Arundel Medical Center in Annapolis, Pennsylvania Cancer Specialists and Research Institute in Gettysburg, and University of Colorado's Aurora location."

Answered by AI

What are the desired outcomes of this research endeavor?

"The primary purpose of this 14-month medical trial is to identify a tolerable maximum dose (MTD) or therapeutically effective amount (PAD). Secondary objectives include examining patients' responses as categorized by RECIST 1.1 and mRECIST, gauging the Area Under the Curve of NC318, and calculating Maximum Plasma Concentration levels for NC318."

Answered by AI

What is the total population participating in this medical experiment?

"Affirmative. Clinicaltrials.gov's records demonstrate that this medical research is in the midst of recruiting participants, which began on September 28th 2018 and was recently updated on August 17th 2022. Currently, 187 patients are being accepted for study at 9 different sites."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Safety and Tolerability Study of NC318 in Subjects With Advanced or Metastatic Solid Tumors
2018. "A Safety and Tolerability Study of NC318 in Subjects With Advanced or Metastatic Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03665285.
~17 spots leftby Apr 2025
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