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A Safety and Tolerability Study of NC318 in Subjects With Advanced or Metastatic Solid Tumors | Clinical Trials | Clareo Health

COMPLETEDPHASE1/PHASE2

A Safety and Tolerability Study of NC318 in Subjects With Advanced or Metastatic Solid Tumors

A Phase 1/2, Open-Label, Dose-Escalation, Safety and Tolerability Study of NC318 in Subjects With Advanced or Metastatic Solid Tumors

NCT03665285•NextCure, Inc.

View on ClinicalTrials.gov

Summary

This research study is studying a new drug, NC318, 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.
•Subjects with advanced unresectable and/or metastatic solid tumors.
•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.
•Able to provide pretreatment tumor tissue sample at Screening.
•Subjects of childbearing potential (defined as female subjects who have not undergone surgical sterilization with a hysterectomy and/or bilateral oophorectomy and are not postmenopausal, defined as ≥ 12 months of amenorrhea not caused by reversible conditions, diseases, or medications) and non-sterilized male subjects must agree to take appropriate precautions to avoid pregnancy or fathering children (with at least 99% certainty) from screening through 90 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.
•7. International normalized ratio (INR) or prothrombin time (PT) \> 1.5 × ULN or activated partial thromboplastin time (aPTT) \> 1.5 × ULN
•Transfusion of blood products (including platelets or red blood cells) or administration of colony-stimulating factors (including granulocyte colony-stimulating factor, granulocyte macrophage colony-stimulating factor, or recombinant erythropoietin) within 7 days before the first administration of study drug.
+21 more criteria

Locations (6)

The Angeles Clinic and Research Institute

Los Angeles, California, United States

Yale University Cancer Center

New Haven, Connecticut, United States

John Theurer Cancer Center at Hackensack University Medical Center

Hackensack, New Jersey, United States

Laura and Isaac Perlmutter Cancer Center

New York, New York, United States

Pennsylvania Cancer Specialists and Research Institute

Gettysburg, Pennsylvania, United States

NEXT Oncology

San Antonio, Texas, United States

Key Dates

Start Date

October 1, 2018

Primary Completion Date

April 11, 2023

Completion Date

April 11, 2023

Last Updated

March 8, 2024

Enrollment

109

ACTUAL participants

Conditions

Advanced or Metastatic Solid TumorsLung CancerBreast CancerHead and Neck Squamous Cell CarcinomaEndometrial CancerMelanomaCRCUrothelial CarcinomaCholangiocarcinoma

Interventions

NC318

DRUG

Immunotherapy After Surgery for People Who Have No Remaining Cancer Cells After Standard Treatment for Early-Stage Non-Small Cell Lung Cancer, INSIGHT Trial

NCT06498635

Lung Non-Small Cell CarcinomaStage II Lung Cancer AJCC v8+2 more

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RECRUITINGPHASE2

Andamertinib With or Without Platinum-doublet Chemotherapy Versus Platinum-doublet Chemotherapy in Patients With NSCLC Harboring Atypical EGFR Mutations

NCT07336732

Non-Small-Cell Lung Cancer

View study

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: March 8, 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.

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A Safety and Tolerability Study of NC318 in Subjects With Advanced or Metastatic Solid Tumors

Inclusion Criteria

Exclusion Criteria

Immunotherapy After Surgery for People Who Have No Remaining Cancer Cells After Standard Treatment for Early-Stage Non-Small Cell Lung Cancer, INSIGHT Trial

Andamertinib With or Without Platinum-doublet Chemotherapy Versus Platinum-doublet Chemotherapy in Patients With NSCLC Harboring Atypical EGFR Mutations

Safety and Feasibility of Robotic SP Nipple Sparing Mastectomy

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Testing the Addition of an Anti-cancer Drug, ASTX727 (Cedazuridine, Decitabine), to Chemotherapy (Paclitaxel) and Immunotherapy (Pembrolizumab) for Metastatic Triple-Negative Breast Cancer