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Trial record 1 of 1 for:    NEON-2
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ALPN-202 With PD-1 Inhibition in Advanced Malignancies (NEON-2)

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. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT04920383
Recruitment Status : Active, not recruiting
First Posted : June 9, 2021
Last Update Posted : November 9, 2022
Information provided by (Responsible Party):
Alpine Immune Sciences, Inc.

Brief Summary:
This is a cohort-based, open-label dose escalation and expansion study in adults with advanced solid tumors or lymphoma.

Condition or disease Intervention/treatment Phase
Advanced Solid Tumor Lymphoma Drug: ALPN-202 Drug: Pembrolizumab Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label Study of ALPN-202 Combined With PD-1 Inhibition in Subjects With Advanced Malignancies (NEON-2)
Actual Study Start Date : June 22, 2021
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2024

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Dose Escalation and Expansion
ALPN-202 + Pembrolizumab
Drug: ALPN-202
Various doses

Drug: Pembrolizumab

Primary Outcome Measures :
  1. Dose-limiting Toxicities (DLTs) [ Time Frame: Up to 6 weeks following study day 1 ]
    Incidence of DLTs

  2. Adverse Events (AEs) [ Time Frame: 30 days after last dose of study drug ]
    Type, incidence, severity, and seriousness of AEs

  3. Laboratory Abnormalities [ Time Frame: Up to 30 days after last dose of study drug ]
    Type, incidence, and severity of laboratory abnormalities

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.

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Adult 18 to 80 years old at screening
  • Pathologically confirmed, locally advanced or metastatic unresectable solid tumor, or Hodgkin or Non-Hodgkin lymphoma (including transformed lymphoma) of an acceptable histology:

    1. that is eligible for treatment with a PD-1 or PD-L1 inhibitor, or
    2. that is refractory or resistant to standard therapy, or
    3. for which standard or curative therapy is not available.
  • Have received ≥ 2 prior systemic anti-cancer therapies (lymphoma subjects only)
  • Protocol-defined measurable disease
  • Available tumor biopsy representative of current disease
  • ECOG performance status grade 0-1
  • Life expectancy of ≥ 3 months
  • Recovery to Grade ≤ 1 for any non-laboratory toxicity resulting from previous anticancer therapy prior to first dose of ALPN-202 (except alopecia, hearing loss, Grade ≤ 2 neuropathy, or endocrinopathy managed with replacement therapy)
  • Adequate baseline hematologic, renal, hepatic and cardiac function

Exclusion Criteria:

  • Any history of ≥ Grade 3 immune-related adverse event (irAE) requiring discontinuation from treatment or any history of a cardiovascular irAE
  • Active or prior pneumonitis or interstitial lung disease
  • Presence of any active central nervous system metastases
  • Prior organ allograft or allogeneic hematopoietic stem cell transplantation
  • Any other serious or uncontrolled health condition, which, in the opinion of the Investigator, would place the subject at undue risk from the study, impair the ability of the subject to receive protocol specified therapy, or interfere with the interpretation of study results.
  • Receipt of any protocol-restricted therapy within the timeframes indicated:

    1. Checkpoint inhibitors, including PD-(L)1 (e.g., pembrolizumab, nivolumab, cemiplimab, avelumab, durvalumab), CTLA-4 (e.g., ipilimumab, tremelimumab), and Lag-3 (e.g., relatlimab), costimulatory agonists (including but not limited to CD28, CD134 (OX40), CD137 (4-1BB)): 3 months (135 days for atezolizumab)
    2. Chemotherapy, small molecule anticancer agents (e.g., kinase inhibitors), or radiation: 2 weeks
    3. Other monoclonal antibodies, antibody-drug conjugates, bispecific antibodies, antibody-like drugs, cytokines, cell therapies, or radioimmunoconjugates: 4 weeks
  • Any active, known, or suspected autoimmune disease
  • Systemic treatment with corticosteroids (> 10 mg/day prednisone) or other immunosuppressive medication
  • Any second malignancy active within the previous 3 years
  • Active infection requiring therapy at the time of the first dose of ALPN-202.
  • Known seropositivity for or active infection by human immunodeficiency virus, hepatitis B or C, or or Severe Acute Respiratory Syndrome Coronavirus 2.
  • Known allergies, hypersensitivity, or intolerance to ALPN-202 or excipients in the drug product formulation.
  • History of Grade 4 infusion-related, anaphylactic or allergic reaction to any previous Fc-based protein therapy.
  • Any serious or uncontrolled cardiovascular condition, including but not limited to:

    1. Any history of myocarditis of any etiology
    2. History of New York Heart Association Class III or IV congestive heart failure, myocardial infarction, unstable angina, cerebrovascular accident, cardiac hospitalization, or other acute uncontrolled heart disease within 6 months of scheduled C1D1
    3. Left ventricular ejection fraction < 45% on screening echocardiogram
    4. Any clinically significant findings on screening EKG such as atrial or ventricular arrythmia (other than sinus tachycardia) or AV conduction abnormality such as left bundle branch block (such subjects may be enrolled after cardiology clearance and Medical Monitor approval)
  • Has received prior radiotherapy within 2 weeks of start of study treatment, or have had a history of radiation pneumonitis

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): NCT04920383

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United States, Georgia
Investigational Site (213)
Atlanta, Georgia, United States, 30322
United States, Massachusetts
Investigational Site (212)
Boston, Massachusetts, United States, 02114
United States, Michigan
Investigational Site (301)
Grand Rapids, Michigan, United States, 49546
United States, Tennessee
Investigational Site (203)
Nashville, Tennessee, United States, 37203
United States, Texas
Investigational Site (215)
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Alpine Immune Sciences, Inc.
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Responsible Party: Alpine Immune Sciences, Inc.
ClinicalTrials.gov Identifier: NCT04920383    
Other Study ID Numbers: AIS-B02
First Posted: June 9, 2021    Key Record Dates
Last Update Posted: November 9, 2022
Last Verified: November 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Antineoplastic Agents, Immunological
Antineoplastic Agents
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action