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An Open-label Study of ALPN-202 in Subjects With Advanced Malignancies (NEON-1)

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ClinicalTrials.gov Identifier: NCT04186637
Recruitment Status : Recruiting
First Posted : December 5, 2019
Last Update Posted : August 27, 2020
Sponsor:
Information provided by (Responsible Party):
Alpine Immune Sciences, Inc.

Study Description
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Brief Summary:
This is a cohort-based, open-label dose escalation and expansion study in adults with advanced solid tumors or lymphoma, refractory or resistant to standard therapy, or without available standard or curative therapy.

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 102 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 in Subjects With Advanced Malignancies (NEON-1)
Actual Study Start Date : June 2, 2020
Estimated Primary Completion Date : December 2024
Estimated Study Completion Date : December 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Dose escalation and expansion
ALPN-202 0.001 - 20 mg/kg IV
 Drug: ALPN-202
ALPN-202 0.001 - 20 mg/kg IV


Outcome Measures
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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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  1. Adult 18 to 75 years old at screening
  2. Pathologically-confirmed, locally advanced or metastatic unresectable solid tumor, or lymphoma that is refractory or resistant to standard therapy, or for which standard or curative therapy is not available
  3. Have received ≥ 2 prior systemic anti-cancer therapies (lymphoma subjects only)
  4. Protocol-defined measurable disease
  5. Available tumor biopsy representative of current disease
  6. ECOG performance status grade 0-2
  7. Life expectancy of ≥ 3 months
  8. 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)
  9. Adequate baseline hematologic, renal, and hepatic function

Key Exclusion Criteria:

  1. Any history of ≥ Grade 3 immune-related adverse event (irAE)
  2. Active or prior pneumonitis or interstitial lung disease
  3. Presence of any active central nervous system metastases
  4. Prior organ allograft or allogeneic hematopoietic stem cell transplantation
  5. 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.

  6. 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. 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
  7. Any active, known, or suspected autoimmune disease
  8. Systemic treatment with corticosteroids (> 10 mg/day prednisone) or other immunosuppressive medication
  9. Any second malignancy active within the previous 3 years
  10. Active infection requiring therapy at the time of the first dose of ALPN-202.
  11. Known seropositivity for or active infection by human immunodeficiency virus, hepatitis B or C.
  12. Known allergies, hypersensitivity, or intolerance to ALPN-202 or excipients in the drug product formulation.
  13. History of Grade 4 infusion-related, anaphylactic or allergic reaction to any previous Fc-based protein therapy.
Contacts and Locations
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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): NCT04186637


Contacts
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Contact: AIS-B01 Study Manager +1-206-788-4545 almudena.tercero@alpineimmunesciences.com

Locations
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United States, Arizona
Honor Health Recruiting
Scottsdale, Arizona, United States, 85258
United States, Indiana
Horizon Oncology Not yet recruiting
Lafayette, Indiana, United States, 47905
United States, Michigan
START Midwest Recruiting
Grand Rapids, Michigan, United States, 49546
Australia, Nedlands
Linear Research Recruiting
Perth, Nedlands, Australia, 6009
Australia, Victoria
Nucleus Network Pty Ltd Recruiting
Melbourne, Victoria, Australia, 3004
Sponsors and Collaborators
Alpine Immune Sciences, Inc.
Investigators
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Study Director: Stanford Peng, MD PhD Alpine Immune Sciences
More Information
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Responsible Party: Alpine Immune Sciences, Inc.
ClinicalTrials.gov Identifier: NCT04186637    
Other Study ID Numbers: AIS-B01
First Posted: December 5, 2019    Key Record Dates
Last Update Posted: August 27, 2020
Last Verified: August 2020

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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