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Trial record 1 of 1 for:    NC762-01
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A Safety and Tolerability Study of NC762 in Subjects With Advanced or Metastatic Solid Tumors

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ClinicalTrials.gov Identifier: NCT04875806
Recruitment Status : Not yet recruiting
First Posted : May 6, 2021
Last Update Posted : May 6, 2021
Sponsor:
Information provided by (Responsible Party):
NextCure, Inc.

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

Condition or disease Intervention/treatment Phase
Advanced or Metastatic Solid Tumors Ovarian Cancer Non-small Cell Lung Cancer Breast Cancer Drug: NC762 Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 176 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1/2, Open-Label, Dose-Escalation, Safety and Tolerability Study of NC762 in Subjects With Advanced or Metastatic Solid Tumors
Estimated Study Start Date : June 2021
Estimated Primary Completion Date : October 2024
Estimated Study Completion Date : October 2024


Arm Intervention/treatment
Experimental: NC762
NC762 for injections of various dose strengths administered in 14 day dosing cycles
Drug: NC762
NC762 is an experimental antibody drug that may make the immune response more active against cancer




Primary Outcome Measures :
  1. Number of participants with treatment-emergent adverse events as assessed by CTCAE v5.0 [ Time Frame: Up to 15 months ]
    Frequency, duration, and severity of treatment-emergent adverse events (AEs)

  2. Define a maximum tolerated dose (MTD) or pharmacologically active dose (PAD) [ Time Frame: 28 days ]
    A 3 + 3 design will be utilized to determine the MTD of NC762


Secondary Outcome Measures :
  1. Objective Response Rate per RECIST [ Time Frame: Up to 15 months ]
    Objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and modified RECIST(mRECIST) v1.1

  2. Duration of Response per RECIST [ Time Frame: Up to 15 months ]
    Duration of Response (DoR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and modified RECIST (mRECIST) v1.1

  3. Disease Control Rate per RECIST [ Time Frame: Up to 15 months ]
    Disease Control Rate (DCR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and modified RECIST (mRECIST) v1.1

  4. Maximum Plasma Concentration (Cmax) of NC762 [ Time Frame: Up to 15 months ]
    To evaluate the Maximum Plasma Concentration (Cmax) of NC762



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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) 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 90 days after the last dose of study drug.

Exclusion Criteria:

  • Inability to comprehend or unwilling to sign the ICF.
  • Laboratory and medical history parameters not within the protocol-defined range. If the screening laboratory tests below were conducted > 7 days before treatment initiation, then the tests must be repeated, and eligibility confirmed before study drug administration on Cycle 1 Day 1.

    1. Absolute neutrophil count < 1.5 × 10^9/L.
    2. Platelets < 100 × 10^9/L.
    3. Hemoglobin < 9 g/dL or < 5.6 mmol/L.
    4. Serum creatinine > 1.5 × institutional upper limit of normal (ULN) and measured or calculated creatinine clearance (glomerular filtration rate can also be used in place of creatinine or creatinine clearance) < 50 mL/min for subjects with creatinine levels > 1.5 × institutional ULN.
    5. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≥ 2.5 × ULN. Note: Subjects with 1) bone metastases may enroll if the Alkaline phosphatase ≥ 1.5 ULN, provided there is no co-existing liver disease OR 2) hepatic parenchymal metastases on screening radiographic examinations may enroll if the ALT or AST is ≤ 5 × ULN only with medical monitor approval.
    6. 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.
    7. International normalized ratio (INR) or prothrombin time (PT) > 1.5 × ULN; Activated partial thromboplastin time (aPTT) > 1.5 × ULN only for subjects who are not on anticoagulation therapy; subjects who are on anticoagulation treatments should be on a stable dose.
  • 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:

    1. ≤ 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.
    2. ≤ 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).
    3. ≤ 28 days for a prior mAb used for anticancer therapy except for denosumab.
    4. ≤ 7 days for immune-suppressive-based treatment for any reason.
    5. ≤ 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.
    6. ≤ 28 days for a COVID-19 vaccine. Note: Potential subjects who have previously been administered a COVID-19 vaccine should wait at least approximately 1 month after the administration of the first dose OR 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 apart from cured basal cell or squamous cell carcinoma of the skin, superficial bladder cancer, prostate intraepithelial neoplasm, carcinoma in situ of the cervix, or other noninvasive or indolent malignancy, or cancers from which the subject has been disease-free for > 1 year, after treatment with curative intent.
  • 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.
  • Active infection requiring systemic therapy.
  • Evidence of hepatitis B virus (HBV) or hepatitis C virus (HCV), unless the hepatitis is considered to be cured.
  • Known history of HIV (HIV 1 or HIV 2 antibodies).
  • Known allergy or reaction to any component of study drug or formulation components.
  • Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 90 days after the last dose of study treatment.
  • Any condition that would, in the investigator's judgment, interfere with full participation in the study, including administration of study drug and attending required study visits; pose a significant risk to the subject; or interfere with interpretation of study data.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04875806


Contacts
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Contact: Associate Director of Clinical Operations at NextCure, Inc. (240) 763-0535 NCClin@nextcure.com
Contact: Director of Clinical Research (407) 432-1521 NelsonM@NextCure.com

Sponsors and Collaborators
NextCure, Inc.
Investigators
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Study Director: Han Myint, MD NextCure, Inc.
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Responsible Party: NextCure, Inc.
ClinicalTrials.gov Identifier: NCT04875806    
Other Study ID Numbers: NC762-01
First Posted: May 6, 2021    Key Record Dates
Last Update Posted: May 6, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by NextCure, Inc.:
Advanced Cancer
Metastatic Cancer
NC762
Solid Tumor
Immunotherapy
PK
Ovarian Cancer
Lung Cancer
Breast Cancer
Additional relevant MeSH terms:
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Ovarian Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders