Neoplasms

Digestive System Diseases

All Conditions

Symptoms and General Pathology

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Rare Diseases

Stomach Neoplasms

Neoplasm Metastasis

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Rectal 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

Ovarian Cancer

Stomach Cancer

Ovarian Epithelial Cancer

All Drugs and Chemicals

Antibodies

Immunomodulating Agents

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

NC410

Han Myint, MD

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

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

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

Spots Global Cancer Trial Database for A Safety and Tolerability Study of NC410 in Subjects With Advanced or Metastatic Solid Tumors

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial