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ALPN-202 With PD-1 Inhibition in Advanced Malignancies (NEON-2)

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ClinicalTrials.gov Identifier: NCT04920383
Recruitment Status : Recruiting
First Posted : June 9, 2021
Last Update Posted : November 9, 2021
Sponsor:
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)
Estimated Enrollment : 323 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 : August 2024
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
Varies




Primary Outcome Measures :
  1. Adverse events [ Time Frame: Up to 30 days after last dose of study drug ]
    Type, incidence, and severity of adverse events as assessed by CTCAE


Secondary Outcome Measures :
  1. Objective response [ Time Frame: Up to 30 days after last dose of study drug ]
    Best observed objective responses as assessed by RECIST for solid tumors, or Lugano for lymphoma



Information from the National Library of Medicine

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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
Criteria

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, and hepatic function

Exclusion Criteria:

  • Any history of ≥ Grade 3 immune-related adverse event (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 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. PD-L1 inhibitors: 5 half-lives (e.g., atezolizumab, 135 days; avelumab, 31 days; durvalumab, 85 days)
    2. PD-1 inhibitors: one scheduled standard dosing interval
    3. Other checkpoint inhibitors, including CTLA-4 inhibitors (e.g., ipilimumab, tremelimumab): 4 weeks
    4. Chemotherapy, small molecule anticancer agents (e.g., kinase inhibitors), or radiation: 2 weeks
    5. 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.

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


Contacts
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Contact: Sean Lee +1 905 690 5484 Sean.Lee@iconplc.com

Locations
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United States, Massachusetts
Investigational Site (212) Recruiting
Boston, Massachusetts, United States, 02114
United States, Michigan
Investigational Site (301) Recruiting
Grand Rapids, Michigan, United States, 49546
United States, Tennessee
Investigational Site (203) Recruiting
Nashville, Tennessee, United States, 37203
United States, Texas
Investigational Site (215) Recruiting
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Alpine Immune Sciences, Inc.
Investigators
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Study Director: Stanford Peng, MD, PhD 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, 2021
Last Verified: November 2021

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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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Neoplasms
Pembrolizumab
Antineoplastic Agents, Immunological
Antineoplastic Agents