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NC410 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, NC410, as a potential treatment for cancer that has spread or returned.

Eligible Conditions
  • Advanced or Metastatic Solid Tumors
  • Colorectal Cancer
  • Ovarian Cancer
  • Stomach 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
Define a maximum tolerated dose (MTD) or pharmacologically active dose (PAD)
Number of participants with treatment-emergent adverse events as assessed by CTCAE v5.0
Secondary outcome measures
Area Under the Curve (AUC) of NC410
Disease Control Rate per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Duration of Response per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and Modified Response Evaluation Criteria in Solid Tumors
+5 more

Trial Design

7Treatment groups
Experimental Treatment
Group I: NC410 6mgExperimental Treatment1 Intervention
6mg of NC410 for IV infusion administered in 14 day dosing cycles
Group II: NC410 60mgExperimental Treatment1 Intervention
60mg of NC410 for IV infusion administered in 14 day dosing cycles
Group III: NC410 3mgExperimental Treatment1 Intervention
3mg of NC410 for IV infusion administered in 14 day dosing cycles
Group IV: NC410 30mgExperimental Treatment1 Intervention
30mg of NC410 for IV infusion administered in 14 day dosing cycles
Group V: NC410 200mgExperimental Treatment1 Intervention
200mg of NC410 for IV infusion administered in 14 day dosing cycles
Group VI: NC410 15mgExperimental Treatment1 Intervention
15mg of NC410 for IV infusion administered in 14 day dosing cycles
Group VII: NC410 100mgExperimental Treatment1 Intervention
100mg of NC410 for IV infusion administered in 14 day dosing cycles

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Who is running the clinical trial?

NextCure, Inc.Lead Sponsor
6 Previous Clinical Trials
502 Total Patients Enrolled
Han Myint, MDStudy DirectorNextCure, Inc.
4 Previous Clinical Trials
343 Total Patients Enrolled
~9 spots leftby Jun 2025
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