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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

Find a Location

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

Frequently Asked Questions

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

Are there various venues engaging in this experiment within the municipality?

"The National Cancer Institute (NCI) in Bethesda, Maryland, the UPMC Hillman Cancer Center in Pittsburgh, Pennsylvania, and the UT MD Anderson Cancer Center in Houston are all recruiting patients for this trial. In addition to these locations there are 5 other sites participating."

Answered by AI

What outcomes is this clinical trial aiming to obtain?

"The primary goal of this 28 day trial is to determine the number of participants with treatment-emergent adverse events through CTCAE v5.0 assessment. Secondary objectives include establishing a Disease Control Rate (DCR) per RECIST/mRECIST, Maximum Plasma Concentration (Cmax) for NC410 and Duration of Response (DoR) based on RECIST/mRECIST criteria."

Answered by AI

Is enrollment in this experiment still open to participants?

"As per clinicaltrials.gov, this medical experiment is currently open for recruitment. This trial was initially published on June 10th 2020 and then revised on May 25th 2022."

Answered by AI

What is the current cohort size for this clinical experiment?

"Affirmative. According to the clinicaltrials.gov repository, this medical trial is currently seeking out participants with 128 total enrollees needed from 5 distinct sites. The study was initially published on June 10th 2020 and its data was updated most recently on May 25th 2022."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Safety and Tolerability Study of NC410 in Subjects With Advanced or Metastatic Solid Tumors
2020. "A Safety and Tolerability Study of NC410 in Subjects With Advanced or Metastatic Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04408599.
~10 spots leftby Apr 2025
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