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

Stopped early · Phase 1/Phase 2

Conditions studied: Advanced or Metastatic Solid Tumors, Ovarian Cancer, Non-small Cell Lung Cancer, Breast Cancer

In brief

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

Key facts

Study ID

NCT04875806

Run by

NextCure, Inc.

People needed

40

Starts

2021-06-30

Expected to finish

2024-01-30

Last updated by the study team

2025-04-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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.
• ≤ 28 days or 5 half-lives, t½, (whichever is longer) before the first dose for all other investigational study drugs or devices. For investigational agents with long half-lives (e.g., > 5 days), enrollment before the fifth t½ requires medical monitor approval.
• ≤ 14 days for a COVID-19 vaccine. Note: For 2-dose vaccines, subjects must wait at least 14 days after administration of the 2nd dose of the vaccine prior to receiving the first dose of the study drug.
• Has not recovered to ≤ Grade 1 from toxic effects of prior therapy (including prior immunotherapy and radiation therapy) and/or complications from prior surgical intervention before starting therapy.
• Receipt of a live vaccine within 30 days of planned start of study therapy.
• Active autoimmune disease that required systemic treatment in the past (i.e., with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs).
• Known active CNS metastases and/or carcinomatous meningitis.
• Known concurrent malignancy that is progressing or requires active treatment, or history of other malignancy within 2 years of study entry.
• Evidence of active, noninfectious pneumonitis or history of interstitial lung disease.
• Documented known activating or driver mutations (i.e. EGFR mutations/amplification, BRAF mutations, ALK alterations, etc.) which have not been previously treated with a standard of care targeted therapy.
• Subjects with screening QTc interval > 470 milliseconds (corrected by Fridericia) are excluded.

Where it is running

• Yale Cancer Center — New Haven, Connecticut, United States
• The University of Chicago Medicine and Biological Sciences — Chicago, Illinois, United States
• John Theurer Cancer Center at Hackensack University Medical Center — Hackensack, New Jersey, United States
• Roswell Park Cancer Institute — Buffalo, New York, United States
• Carolina BioOncology Institute — Huntersville, North Carolina, United States
• Gettysburg Cancer Center — Gettysburg, Pennsylvania, United States
• UPMC Hillman Cancer Center — Pittsburgh, Pennsylvania, United States
• Inova Schar Cancer Institute — Fairfax, Virginia, United States

Full record on ClinicalTrials.gov

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