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A Safety and Tolerability Study of NC410 in Subjects With Advanced or Metastatic Solid Tumors | Clinical Trials | Clareo Health

TERMINATEDPHASE1/PHASE2

A Safety and Tolerability Study of NC410 in Subjects With Advanced or Metastatic Solid Tumors

A Phase 1/2, Open-Label, Dose-Escalation, Safety and Tolerability Study of NC410 in Subjects With Advanced or Metastatic Solid Tumors

NCT04408599•NextCure, Inc.

View on ClinicalTrials.gov

Summary

This research study is studying a new drug, NC410, as a possible treatment for advanced or metastatic solid tumors.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Men and women aged 18 or older.
•Willingness to provide written informed consent for the study.
•Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1.
•Locally advanced or metastatic disease; locally advanced disease must not be amenable to resection with curative intent.
•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. Note: There is no limit to the number of prior treatment regimens.
•Presence of measurable disease based on RECIST v1.1. Tumor lesions situated in a previously irradiated area, or in an area subjected to other locoregional therapy, are not considered measurable unless there has been demonstrated progression in the lesion.
•After dose escalation, subject must be willing to undergo pretreatment and on-treatment tumor biopsies (core or excisional). Note: A baseline biopsy obtained for other purposes (i.e., not an NC410-01 study procedure) before signing consent may be utilized if the subject has not had any intervening systemic therapy from the time of the biopsy to the start of treatment with the medical monitor's approval.
•Female subjects 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. All female and male subjects of childbearing potential must agree to take appropriate precautions to avoid pregnancy or fathering children (with at least 99% certainty) from screening through 60 days after the last dose of study drug.

Exclusion Criteria

•Inability to comprehend or unwilling to sign the Informed Consent Form.
•Screening laboratory values of:
•1. Absolute neutrophil count \< 1.5 × 10\^9/L
•2. Platelets \< 100 × 10\^9/L
•3. Hemoglobin \< 9 g/dL or \< 5.6 mmol/L
•4. Serum creatinine \> 1.5 × institutional upper limit of normal (ULN)
•5. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≥ 2.5 × ULN
•6. Total bilirubin ≥ 1.5 × ULN unless conjugated bilirubin ≤ ULN (conjugated bilirubin only needs to be tested if total bilirubin exceeds ULN). If there is no institutional ULN, then direct bilirubin must be \< 40% of total bilirubin.
•7. International normalized ratio (INR) or prothrombin time (PT) \> 1.5 × ULN
•8. Activated partial thromboplastin time (aPTT) \> 1.5 × ULN
+19 more criteria

Locations (5)

NIH National Cancer Institute (NCI)

Bethesda, Maryland, United States

John Theurer Cancer Center at Hackensack University Medical Center

Hackensack, New Jersey, United States

NYU Langone Health

New York, New York, United States

UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania, United States

UT MD Anderson Cancer Center

Houston, Texas, United States

Key Dates

Start Date

June 10, 2020

Primary Completion Date

July 6, 2023

Completion Date

July 6, 2023

Last Updated

July 25, 2024

Enrollment

ACTUAL participants

Conditions

Advanced or Metastatic Solid TumorsOvarian CancerGastric CancerColo-rectal Cancer

Interventions

NC410

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 25, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

A Safety and Tolerability Study of NC410 in Subjects With Advanced or Metastatic Solid Tumors

Inclusion Criteria

Exclusion Criteria

Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations

Testing the Combination of Two Anti-cancer Drugs, DS-8201a and AZD6738, for The Treatment of Advanced Solid Tumors Expressing the HER2 Protein or Gene, The DASH Trial

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Study of Dato-DXd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03)

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