NC410 for Advanced or Metastatic Solid Tumors

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Advanced or Metastatic Solid Tumors+3 MoreNC410 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

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
  • Stomach Cancer
  • Ovarian Cancer
  • Colorectal Cancer

Treatment Effectiveness

Study Objectives

2 Primary · 4 Secondary · Reporting Duration: 14 months

14 months
Disease Control Rate per RECIST
Duration of Response per RECIST
Objective Response Rate per RECIST
14 weeks
Maximum Plasma Concentration (Cmax) of NC410
28 days
Define a maximum tolerated dose (MTD) or pharmacologically active dose (PAD)
up to 14 months
Number of participants with treatment-emergent adverse events as assessed by CTCAE v5.0

Trial Safety

Trial Design

1 Treatment Group

NC410
1 of 1

Experimental Treatment

128 Total Participants · 1 Treatment Group

Primary Treatment: NC410 · No Placebo Group · Phase 1 & 2

NC410
Drug
Experimental Group · 1 Intervention: NC410 · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 14 months

Who is running the clinical trial?

NextCure, Inc.Lead Sponsor
5 Previous Clinical Trials
551 Total Patients Enrolled
4 Trials studying Advanced or Metastatic Solid Tumors
410 Patients Enrolled for Advanced or Metastatic Solid Tumors
Han Myint, MDStudy DirectorNextCure, Inc.
3 Previous Clinical Trials
410 Total Patients Enrolled
3 Trials studying Advanced or Metastatic Solid Tumors
410 Patients Enrolled for Advanced or Metastatic Solid Tumors

Eligibility Criteria

Age 18+ · All Participants · 8 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have locally advanced or metastatic disease.
You have a performance status of 0 or 1.
Subjects who have disease progression after treatment with available therapies that are known to confer clinical benefit, or who are intolerant to treatment, or who refuse standard treatment
Subjects must be willing to undergo pretreatment and on-treatment tumor biopsies (core or excisional)
Subjects must be of childbearing potential (defined as women who have not undergone surgical sterilization with a hysterectomy and/or bilateral oophorectomy and are not postmenopausal, defined as ≥ 12 months of amenorrhea) must have a negative serum pregnancy test at screening