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

NCT04408599 | Terminated Phase 1 Results FDA Drug

• 1 other identifier: NC410-01
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 5

Brief Summary

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

Conditions

Advanced or Metastatic Solid Tumors; Ovarian Cancer; Gastric Cancer; Colo-rectal Cancer

Keywords

Advanced Cancer; Metastatic Cancer; NC410; Solid Tumor; Immunotherapy; PK; Ovarian Cancer; Gastric Cancer; Colo-rectal Cancer

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Treatment-emergent Adverse Events as Assessed by CTCAE v5.0

  Number of Participants With Treatment-emergent Adverse Events

  From enrollment through up to 90 days after end of treatment, an average of 1 year

Secondary Outcomes (8)

• Objective Response Rate Per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

  Approximately 1 year

• Duration of Response Per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and Modified Response Evaluation Criteria in Solid Tumors

  Approximately 1 year

• Disease Control Rate Per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

  Approximately 1 year

• Maximum Plasma Concentration (Cmax) of NC410

  Days 1, 2, 3 and 8 of Cycles 1 and 5. Each cycle is 14 days in duration.

• Progression-free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and Modified Response Evaluation Criteria in Solid Tumors

  Approximately 1 year

Study Arms (7)

NC410 3mg

EXPERIMENTAL

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

Drug: NC410

NC410 6mg

EXPERIMENTAL

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

Drug: NC410

NC410 15mg

EXPERIMENTAL

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

Drug: NC410

NC410 30mg

EXPERIMENTAL

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

Drug: NC410

NC410 60mg

EXPERIMENTAL

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

Drug: NC410

NC410 100mg

EXPERIMENTAL

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

Drug: NC410

NC410 200mg

EXPERIMENTAL

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

Drug: NC410

Interventions

NC410 DRUG

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

NC410 100mg; NC410 15mg; NC410 200mg; NC410 30mg; NC410 3mg; NC410 60mg; NC410 6mg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Inability to comprehend or unwilling to sign the Informed Consent Form.
• Screening laboratory values of:
• Absolute neutrophil count \< 1.5 × 10\^9/L
• Platelets \< 100 × 10\^9/L
• Hemoglobin \< 9 g/dL or \< 5.6 mmol/L
• Serum creatinine \> 1.5 × institutional upper limit of normal (ULN)
• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≥ 2.5 × ULN
• 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.
• International normalized ratio (INR) or prothrombin time (PT) \> 1.5 × ULN
• 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 14 days before the first administration of study drug.
• Receipt of anticancer medications or investigational drugs within the following intervals before the first administration of study drug:
• ≤ 14 days for chemotherapy, targeted small molecule therapy, or radiation therapy. Subjects must also not require chronic use of corticosteroids and must not have had radiation pneumonitis because of a treatment. A 1-week washout is permitted for palliative radiation to non-central nervous system (CNS) disease with medical monitor approval. Note: Bisphosphonates and denosumab are permitted medications.
• ≤ 28 days for prior immunotherapy or persistence of active cellular therapy (e.g., chimeric antigen receptor T cell therapy; other cellular therapies must be discussed with the medical monitor to determine eligibility).
• ≤ 28 days for a prior monoclonal antibody used for anticancer therapy except for denosumab.

Sponsors & Collaborators

• NextCure, Inc.: lead

Study Sites (5)

NIH National Cancer Institute (NCI)

Bethesda, Maryland, 20892, United States

Location

John Theurer Cancer Center at Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

Location

NYU Langone Health

New York, New York, 10016, United States

Location

UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania, 15232, United States

Location

UT MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Ovarian Neoplasms; Stomach Neoplasms; Colonic Neoplasms; Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Colonic Diseases; Intestinal Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Chief Medical Officer
• Organization: NextCure, Inc

NCClin@nextcure.com

(240) 399-4900

Study Officials

• Han Myint, MD

  NextCure, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2020
• First Posted: May 29, 2020
• Study Start: June 10, 2020
• Primary Completion: July 6, 2023
• Study Completion: July 6, 2023
• Last Updated: July 25, 2024
• Results First Posted: July 25, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)