Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Symptoms and General Pathology

Digestive System Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Rare Diseases

Lung Neoplasms

Neoplasm Metastasis

Stomach Neoplasms

Esophageal Neoplasms

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Uterine Cervical Neoplasms

Head and Neck Neoplasms

Microsatellite Instability

Rectal Neoplasms

Endometrial Neoplasms

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Endocrine System Diseases

Gonadal Disorders

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Stomach Diseases

Colorectal Neoplasms

Intestinal Neoplasms

Intestinal Diseases

Rectal Diseases

Uterine Neoplasms

Uterine Cervical Diseases

Uterine Diseases

Esophageal Diseases

Genomic Instability

Stomach Cancer

Esophageal Cancer

Ovarian Cancer

Ovarian Epithelial Cancer

Antineoplastic Agents

All Drugs and Chemicals

Immune Checkpoint Inhibitors

Pembrolizumab

Immunomodulating Agents

Antineoplastic Agents, Immunological

All participants will receive NC410 (IV) and pembrolizumab (IV) according to the treatment schedule until a reason for treatment discontinuation is reached.

NC410 will be given intravenously (IV) every 2 weeks

NC410

Pembrolizumab 400mg will be given IV every 6 weeks.

pembrolizumab

Associate Director Clinical Operations at NextCure, Inc.

Director of Clinical Research

Julie A Klinker

Sudhir Manda, MD

Jennifer R Hege

Sujatha Nallapareddy, MD

Amy Pajik

Douglas Flora, MD

Nicole Perry

Marc Matrana, MD

Research Referral Office

Eric Christenson, MD

Chelsea McCabe

Martin Gutierrez, MD

Kvitka Peczonczyk

Emese Zsiros

Christine Vollmer

Davendra Sohal, MD

Martha Cruz

Syed Kazmi, MD

Jonathan B Huntzinger

Thomas Hutson, DO

Siqing Fu, MD

Epp Goodwin

Daruka Mahadevan, MD

Debora E Lind

Sridhar Beeram, MD

Stephanie Van Bebber, MSc

Raymond C Wadlow, MD

Carrie Friedman

Alexander Spira, MD

Susan Papenfuse, CRC,RN

David P Cosgrove, MD

Han Myint, MD

This is an open-label, non-randomized, Phase 1b/2 study to determine the safety and tolerability of NC410 when combined with a standard dose of pembrolizumab. This study will also assess the clinical benefit of combination therapy in participants with advanced unresectable and/or metastatic ICI refractory solid tumors OR ICI naïve MSS/MSI-low solid tumors

A Safety, Tolerability and Efficacy Study of NC410 Plus Pembrolizumab in Participants With Advanced Unresectable or Metastatic Solid Tumors

A Phase 1b/2, Open-Label, Safety, Tolerability and Efficacy Study of NC410 Plus Pembrolizumab for Participants With Advanced Unresectable and/or Metastatic Immune Checkpoint Inhibitor (ICI) Refractory Solid Tumors or ICI Naïve MSS/MSI-Low Solid Tumors

Frequency, duration, and severity of treatment-emergent adverse events (AEs)

A mTPI design will be utilized to determine the RP2D of NC410

Objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

Duration of Response (DoR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

Disease Control Rate (DCR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

Merck Sharp & Dohme LLC

NextCure, Inc.

Antibodies

Immunoglobulins

3mg of NC410 for IV infusion administered in 14 day dosing cycles

6mg of NC410 for IV infusion administered in 14 day dosing cycles

15mg of NC410 for IV infusion administered in 14 day dosing cycles

30mg of NC410 for IV infusion administered in 14 day dosing cycles

60mg of NC410 for IV infusion administered in 14 day dosing cycles

100mg of NC410 for IV infusion administered in 14 day dosing cycles

200mg of NC410 for IV infusion administered in 14 day dosing cycles

NC410 is an experimental antibody drug that may make the immune response more active against cancer

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

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

A 3 + 3 design will be utilized to determine the MTD of NC410

To assess antitumor activity/efficacy by evaluating objective response rate (ORR), defined as the percentage of participants who experienced a complete response (CR; disappearance of all target lesions) or a partial response (PR; at least a 30% decrease in the sum of diameters of target lesions) based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

To assess antitumor activity/efficacy by evaluating duration of response (DoR), defined as the time from the first documented complete response or partial response per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or Modified Response Evaluation Criteria in Solid Tumors to the first documented progressive disease or death due to any cause, whichever occurs first.

To assess antitumor activity/efficacy by evaluating disease control rate (DCR), defined as the proportion of participants in whom a documented complete response, partial response, or stable disease is observed as the best overall response per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.

To evaluate the Maximum Plasma Concentration (Cmax) of NC410

To evaluate progression-free survival (PFS), defined as the time from the first dose of NC410 to the first occurrence of documented progressive disease or death due to any cause, whichever occurs first.

To evaluate overall survival (OS), defined as the time from the first dose of NC410 to death due to any cause.

To evaluate the Area Under the Curve (AUC) of NC410

To evaluate the half-life (t1/2) of NC410

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Safety, Tolerability and Efficacy Study of NC410 Plus Pembrolizumab in Participants With Advanced Unresectable or Metastatic Solid Tumors	NCT05572684	Advanced or Met... Microsatellite ... Microsatellite ... Microsatellite ... Ovarian Cancer Gastric Cancer Colo-rectal Can... Esophageal Canc... Endometrial Can... Head Neck Cance... Cervical Cancer Lung Cancer	NC410 pembrolizumab	18 Years -	NextCure, Inc.
A Safety and Tolerability Study of NC410 in Subjects With Advanced or Metastatic Solid Tumors	NCT04408599	Advanced or Met... Ovarian Cancer Gastric Cancer Colo-rectal Can...	NC410	18 Years -	NextCure, Inc.

Spots Global Cancer Trial Database for nc410

Every month we try and update this database with for nc410 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for nc410

Every month we try and update this database with for nc410 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for nc410 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.