A Safety and Tolerability Study of NC762 in Subjects With Advanced or Metastatic Solid Tumors

NCT04875806 | Terminated Phase 1 Results FDA Drug

• 1 other identifier: NC762-01
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 8

Brief Summary

This research study is studying a new drug, NC762, as a possible treatment for advanced or metastatic solid tumors.

Conditions

Advanced or Metastatic Solid Tumors; Ovarian Cancer; Non-small Cell Lung Cancer; Breast Cancer

Keywords

Advanced Cancer; Metastatic Cancer; NC762; Solid Tumor; Immunotherapy; PK; Ovarian Cancer; Lung Cancer; Breast Cancer

Outcome Measures

Primary Outcomes (1)

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

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

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

Secondary Outcomes (8)

• Objective Response Rate (ORR) as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

  Approximately 1 year

• Duration of Response (DoR) as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

  Approximately 1 year

• Disease Control Rate (DCR) as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

  Approximately 1 year

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

  Approximately 1 year

• Overall Survival (OS)

  Approximately 1 year

Study Arms (5)

0.5mg/kg NC762

EXPERIMENTAL

Subjects received NC762 IV at 0.5mg/kg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first).

Drug: NC762

1.5mg/kg NC762

EXPERIMENTAL

Subjects received NC762 IV at 1.5mg/kg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first).

Drug: NC762

5mg/kg NC762

EXPERIMENTAL

Subjects received NC762 IV at 5mg/kg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first).

Drug: NC762

10mg/kg NC762

EXPERIMENTAL

Subjects received NC762 IV at 10mg/kg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first).

Drug: NC762

20mg/kg NC762

EXPERIMENTAL

Subjects received NC762 IV at 20mg/kg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first).

Drug: NC762

Interventions

NC762 DRUG

NC762 is an experimental antibody drug that may make the immune response more active against cancer

0.5mg/kg NC762; 1.5mg/kg NC762; 10mg/kg NC762; 20mg/kg NC762; 5mg/kg NC762

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.
• 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.
• Phase 1a Dose Escalation (optional), Phase 1b Safety Expansion, and Phase 2 (mandatory): Willingness to undergo pretreatment and on-treatment tumor biopsies (core or excisional).
• 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) and non-sterilized 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 90 days after the last dose of study drug. Females of child-bearing potential must have a negative serum pregnancy test at screening.

You may not qualify if:

• Inability to comprehend or unwilling to sign the ICF.
• Laboratory and medical history parameters not within the protocol-defined range.
• 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) and measured or calculated creatinine clearance \< 50 mL/min for subjects with creatinine levels \> 1.5 × institutional ULN.
• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≥ 2.5 × ULN. With the following exceptions: subjects with documented liver metastases AST and/or ALT ≤ 5 × ULN. Patients with documented liver or bone metastases: alkaline phosphatase ≤ 5 ×ULN.
• Total bilirubin ≥ 1.5 × ULN.
• International normalized ratio (INR) or prothrombin time (PT) \> 1.5 × ULN; Activated partial thromboplastin time (aPTT) \> 1.5 × ULN, except for subjects on anticoagulation.
• 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.
• 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, hormonal therapy or radiation therapy. Subjects 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.
• ≤ 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 mAb used for anticancer therapy except for denosumab.
• ≤ 7 days for immune-suppressive-based treatment for any reason.

Sponsors & Collaborators

• NextCure, Inc.: lead

Study Sites (8)

Yale Cancer Center

New Haven, Connecticut, 06519, United States

Location

The University of Chicago Medicine and Biological Sciences

Chicago, Illinois, 60637, United States

Location

John Theurer Cancer Center at Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

Location

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

Location

Carolina BioOncology Institute

Huntersville, North Carolina, 28078, United States

Location

Gettysburg Cancer Center

Gettysburg, Pennsylvania, 17325, United States

Location

UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania, 15232, United States

Location

Inova Schar Cancer Institute

Fairfax, Virginia, 22031, United States

Location

MeSH Terms

Conditions

Ovarian Neoplasms; Carcinoma, Non-Small-Cell Lung; Breast Neoplasms; Neoplasm Metastasis; Lung Neoplasms

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; Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Senior VP, Clinical and Translational Development
• 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

Model Details: Phase 1 will utilize a 3 + 3 design to explore escalating dose levels. Phase 2 Dose Expansion will further evaluate the safety, tolerability, preliminary efficacy, and PK/PD activity of NC762 at the RP2D utilizing a Simon 2-stage design.

Study Record Dates

• First Submitted: May 3, 2021
• First Posted: May 6, 2021
• Study Start: June 30, 2021
• Primary Completion: January 30, 2024
• Study Completion: January 30, 2024
• Last Updated: April 22, 2025
• Results First Posted: April 22, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (8)