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

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: NCT04186637
Recruitment Status : Active, not recruiting
First Posted : December 5, 2019
Last Update Posted : November 14, 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, 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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 62 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 2022
Estimated Study Completion Date : December 2024

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Dose escalation and expansion
Drug: ALPN-202
Multiple dose levels and dose regimens of ALPN-202 will be administered

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 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Key Inclusion Criteria:

  1. Adult 18 to 75 years old at screening
  2. Pathologically-confirmed, locally advanced or metastatic unresectable solid tumor of an acceptable histology

    Part A (Dose Escalation)

    1. that is refractory or resistant to standard therapy, including checkpoint inhibitor(s) if approved
    2. or for which standard or curative therapy is not available

    Part B (Dose Expansion)

    1. metastatic cutaneous melanoma
    2. PD-L1-positive cancers (other than cutaneous melanoma or renal cell carcinoma)
    3. metastatic renal cell carcinoma
  3. Protocol-defined measurable disease
  4. Available tumor biopsy representative of current disease
  5. ECOG performance status grade 0-2
  6. Life expectancy of ≥ 3 months
  7. 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)
  8. Adequate baseline hematologic, renal, and hepatic function

Key Exclusion Criteria:

  1. History of ≥ Grade 3 immune-related adverse event leading to treatment discontinuation
  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.

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

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United States, Arizona
Investigational Site (004)
Scottsdale, Arizona, United States, 85258
United States, Connecticut
Investigational Site (003)
New Haven, Connecticut, United States, 06520
United States, Indiana
Investigational Site (007)
Lafayette, Indiana, United States, 47905
United States, Kentucky
Investigational Site (006)
Louisville, Kentucky, United States, 40202
United States, Michigan
Investigational Site (001)
Grand Rapids, Michigan, United States, 49546
United States, Oregon
Investigational Site (009)
Portland, Oregon, United States, 97213
United States, Pennsylvania
Investigational Site (008)
Pittsburgh, Pennsylvania, United States, 15232
Australia, Nedlands
Investigational Site (102)
Perth, Nedlands, Australia, 6009
Australia, Victoria
Investigational Site (101)
Melbourne, Victoria, Australia, 3004
Investigational Site (103)
Melbourne, Victoria, Australia, 3004
Sponsors and Collaborators
Alpine Immune Sciences, Inc.
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Study Director: Allison Naumovski, Ph.D. Alpine Immune Sciences, Inc.
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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: November 14, 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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