We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04875806
Recruitment Status : Recruiting
First Posted : May 6, 2021
Last Update Posted : June 23, 2022
Sponsor:
Information provided by (Responsible Party):
NextCure, Inc.

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 170 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
Actual Study Start Date : June 30, 2021
Estimated Primary Completion Date : October 2024
Estimated Study Completion Date : October 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: NC762
NC762 for IV infusion 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


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

  5. Downregulation of B7-H4 expression and changes in tumor infiltrating lymphocytes [ Time Frame: Up to 15 months ]
    To evaluate downregulation of B7-H4 expression and changes in tumor infiltrating lymphocytes after NC762 treatment.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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) 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.

Exclusion Criteria:

  • Inability to comprehend or unwilling to sign the ICF.

  • Laboratory and medical history parameters not within the protocol-defined range.

    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 < 50 mL/min for subjects with creatinine levels > 1.5 × institutional ULN.
    5. 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.
    6. Total bilirubin ≥ 1.5 × ULN.
    7. 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:

    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. ≤ 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.
  • Uncontrolled systemic fungal, bacterial, viral, or other infection despite appropriate anti-infection treatment.
  • 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.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Layout table for location contacts
Contact: Associate Director of Clinical Operations at NextCure, Inc. (240) 399-4900 NCClin@nextcure.com
Contact: Director of Clinical Research NelsonM@NextCure.com

Locations
Layout table for location information
United States, Connecticut
Yale Cancer Center Recruiting
New Haven, Connecticut, United States, 06519
Contact: Ingrid Palma, MHS    203-833-1034    ingrid.palma@yale.edu   
Principal Investigator: Patricia LoRusso, MD         
United States, Illinois
The University of Chicago Medicine and Biological Sciences Recruiting
Chicago, Illinois, United States, 60637
Contact: Adekunle Odunsi, MD    855-702-8222    cancerclinicaltrials@bsd.uchicago.edu   
Principal Investigator: Adekunle Odunsi, MD         
United States, New Jersey
John Theurer Cancer Center at Hackensack University Medical Center Recruiting
Hackensack, New Jersey, United States, 07601
Contact: Chelsea McCabe    551-996-5863    Chelsea.McCabe@hackensackmeridian.org   
Principal Investigator: Martin Gutierrez         
United States, New York
Roswell Park Cancer Institute Recruiting
Buffalo, New York, United States, 14263
Contact: Emese Zsiros, MD    716-845-8337    Emses.zsiros@roswellpark.org   
Principal Investigator: Emese Zsiros, MD         
United States, North Carolina
Carolina BioOncology Institute Recruiting
Huntsville, North Carolina, United States, 28078
Contact: Ashley McClain Wallace    980-441-1021    amcclain@carolinabiooncology.org   
Principal Investigator: John Powderly, MD         
United States, Pennsylvania
Gettysburg Cancer Center Recruiting
Gettysburg, Pennsylvania, United States, 17325
Contact: Vanessa Warner    717-334-4033 ext 141    vwarner@gettysburgoncology.com   
Contact: Terry Burke    717-334-4033 ext 131    terry@gettysburgoncology.com   
Principal Investigator: Satish Shah, MD         
UPMC Hillman Cancer Center Recruiting
Pittsburgh, Pennsylvania, United States, 15232
Contact: Sarah Behr    412-623-6028    behrse@upmc.edu   
Principal Investigator: Leisha Emens, MD         
Sponsors and Collaborators
NextCure, Inc.
Investigators
Layout table for investigator information
Study Director: Han Myint, MD NextCure, Inc.
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
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: June 23, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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:
Layout table for MeSH terms
Ovarian Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Ovarian Diseases
 Adnexal Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders