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Advanced or Metastatic Solid TumorsPhase 1/2NCT04430933

A Safety and Tolerability Study of NC318 in Combination With Chemotherapy for Subjects With Advanced or Metastatic NSCLC

A Phase 1/2 study testing NC318, Pemetrexed/Carboplatin and Nab paclitaxel/Carboplatin in people with Advanced or Metastatic Solid Tumors and Non-Small Cell Lung Cancer, run by NextCure, Inc..

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

This research study is studying an investigational drug, NC318, as a possible treatment for subjects with advanced or metastatic non-small cell lung cancer in combination with chemotherapy Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
NC318, Pemetrexed/Carboplatin and Nab paclitaxel/Carboplatin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
6 Dec 2021to 30 Oct 2022
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
  • Have a life expectancy of at least 6 months
  • Locally advanced or metastatic disease; locally advanced disease must not be amenable to resection with curative intent.
  • Disease progression after receipt of a prior systemic immunotherapy such as monoclonal antibodies targeting PD-1, PD-L1, CTLA-4 or other immune modulators with or without chemotherapy.
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  • 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 NC318-02 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.

Who cannot join

  • Inability to comprehend or unwilling to sign the Informed Consent Form.
  • Received more than 1 prior line of systemic anti-cancer therapy for Stage IIIB/IIIc/IV or recurrent NSCLC disease (does not include adjuvant or neoadjuvant treatments).
  • Requires concurrent radiation or other anticancer therapy
  • Screening laboratory values of:
  • Absolute neutrophil count < 1.5 × 10^9/L
  • Platelets < 100 × 10^9/L
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  • 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:
  • ≤ 21 days for chemotherapy 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.
  • ≤ 7 days for immune-suppressive-based treatment for any reason. Note: Use of inhaled or topical steroids or corticosteroid use for radiographic procedures is permitted. Note: The use of physiologic corticosteroid replacement therapy may be approved after consultation with the medical monitor.
  • ≤ 28 days or 5 half-lives (whichever is longer) for prior ICI.
  • Has not recovered to ≤ Grade 1 from toxic effects of prior therapy (including prior immunotherapy) and/or complications from prior surgical intervention before starting therapy. Note: Subjects with stable chronic conditions (≤ Grade 2) not expected to resolve (such as neuropathy and alopecia) are exceptions and may enroll. Note: Subjects with a history of any grade immune-related ocular AE (e.g., episcleritis, scleritis, uveitis) will be excluded. Note: Subjects with a history of a Grade 3 or higher immune-related AE from prior immunotherapies are excluded.
  • History of recurrent Grade 2 pneumonitis attributed to prior treatment with immune checkpoint inhibitor therapy
  • Receipt of a live vaccine within 30 days of planned start of study therapy. Note: Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, chicken pox/zoster, yellow fever, rabies, Bacillus Calmette-Guérin, and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., FluMist®) are live attenuated vaccines and are not allowed.
  • Active autoimmune disease that required systemic treatment in the past (i.e., with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs). Subjects who have not required systemic treatment in the past 2 years may be eligible with approval of the medical monitor. Note: Subjects with hyper/ hypothyroidism are eligible to participate. Note: Replacement and symptomatic therapies (e.g., levothyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) are not considered a form of systemic immune suppressive therapy and are allowed.
  • Known active CNS metastases and/or carcinomatous meningitis. Note: Subjects with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least 28 days before the first dose of study drug and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases or CNS edema, and have not required steroids for at least 7 days before the first dose of study drug.
  • 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.
  • History or presence of an abnormal electrocardiogram (ECG) that, in the investigator's opinion, is clinically meaningful.
  • Active infection requiring systemic therapy.
  • Evidence of hepatitis B virus (HBV) or hepatitis C virus (HCV) infection or risk of reactivation. HBV-DNA and HCV-RNA must be undetectable. Subjects cannot be positive for HBV-DNA, HCV-RNA, hepatitis B surface antigen, or anti-hepatitis B core antibody. Note: Subjects with no prior history of hepatitis B infection who have been vaccinated against hepatitis B and who have a positive antibody against hepatitis B surface antigen test as the only evidence of prior exposure may participate in the study.
  • 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 60 days after the last dose of study treatment.

About this study

Official title: A Phase 1/2 Study of NC318 in Combination With Chemotherapy for Subjects With Advanced or Metastatic Non-Small Cell Lung Cancer

This research study is studying an investigational drug, NC318, as a possible treatment for subjects with advanced or metastatic non-small cell lung cancer in combination with chemotherapy

Being tested
NC318, Pemetrexed/Carboplatin, Nab paclitaxel/Carboplatin, Docetaxel
Keywords
Advanced Cancer, NC318, Metastatic Cancer, Non-Small Cell Lung Cancer, NSCLC, Immunotherapy
Medical subject headings
Carcinoma, Non-Small-Cell Lung, Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NC318Drug

    NC318 is an experimental antibody drug that will be administered by IV infusion on the first day of each 21 day cycle

  • Pemetrexed/CarboplatinDrug

    Pemetrexed/Carboplatin will be administered per the approved respective product label following the infusion of NC318 on the first day of each 21 day cycle

  • Nab paclitaxel/CarboplatinDrug

    Nab-paclitaxel/Carboplatin will be administered per the approved respective product label following the infusion of NC318 on the first day of each 21 day cycle

  • DocetaxelDrug

    Docetaxel will be administered per the approved product label following the infusion of NC318 on the first day of each 21 day cycle

Study groups in NCT04430933
Study groupRoleWhat they receive
NC318 + Pemetrexed/CarboplatinExperimentalNC318 at various dose strengths administered on the first day of each 21 day cycle in combination with pemetrexed/carboplatin
Receives: Drug: NC318; Drug: Pemetrexed/Carboplatin
NC318 + Nab-paclitaxel/carboplatinExperimentalNC318 at various dose strengths administered on the first day of each 21 day cycle in combination with Nab-paclitaxel/carboplatin
Receives: Drug: NC318; Drug: Nab paclitaxel/Carboplatin
NC318 + DocetaxelExperimentalNC318 at various dose strengths administered on the first day of each 21 day cycle in combination with Docetaxel
Receives: Drug: NC318; Drug: Docetaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: 14 months

Secondary outcomes (6)

  1. Objective Response Rate per RECIST

    Objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and modified RECIST (mRECIST) v1.1

    Measured: 14 months

  2. Duration of Response per RECIST

    Duration of Response (DoR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and modified RECIST (mRECIST) v1.1

    Measured: 14 months

  3. Disease Control Rate per RECIST

    Disease Control Rate (DCR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and modified RECIST (mRECIST) v1.1

    Measured: 14 months

  4. Progression-Free Survival per RECIST

    Progression-Free Survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and modified RECIST (mRECIST) v1.1

    Measured: 14 months

  5. Overall Survival per RECIST

    Overall Survival (OS) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and modified RECIST (mRECIST) v1.1

    Measured: 14 months

  6. Maximum Plasma Concentration (Cmax) of NC318

    To evaluate the Maximum Plasma Concentration (Cmax) of NC410

    Measured: 14 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jun 2020
  2. Study start6 Dec 2021 (estimated)
  3. Primary completion30 Jun 2022 (estimated)
  4. Study completion30 Oct 2022 (estimated)

Why it stopped: Upon reviewing current available combo studies, the sponsor decided to prioritize different combo study.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04430933
Sponsor's protocol ID
NC318-02
Status last verified
Aug 2021
First submitted
11 Jun 2020
Last updated
18 Aug 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing NC318, Pemetrexed/Carboplatin and Nab paclitaxel/Carboplatin in people with Advanced or Metastatic Solid Tumors and Non-Small Cell Lung Cancer, run by NextCure, Inc..

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 18 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants with treatment-emergent adverse events as assessed by CTCAE v5.0 (time frame: 14 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04430933.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2021.

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