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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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.

Tracking Information
First Submitted Date  ICMJE November 27, 2019
First Posted Date  ICMJE December 5, 2019
Last Update Posted Date August 27, 2020
Actual Study Start Date  ICMJE June 2, 2020
Estimated Primary Completion Date December 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 2, 2019)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 2, 2019)
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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE An Open-label Study of ALPN-202 in Subjects With Advanced Malignancies
Official Title  ICMJE An Open-label Study of ALPN-202 in Subjects With Advanced Malignancies (NEON-1)
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Advanced Solid Tumor
  • Lymphoma
Intervention  ICMJE Drug: ALPN-202
ALPN-202 0.001 - 20 mg/kg IV
Study Arms  ICMJE Experimental: Dose escalation and expansion
ALPN-202 0.001 - 20 mg/kg IV
Intervention: Drug: ALPN-202
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 2, 2019)
102
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2024
Estimated Primary Completion Date December 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: AIS-B01 Study Manager +1-206-788-4545 almudena.tercero@alpineimmunesciences.com
Listed Location Countries  ICMJE Australia,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04186637
Other Study ID Numbers  ICMJE AIS-B01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Alpine Immune Sciences, Inc.
Study Sponsor  ICMJE Alpine Immune Sciences, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Stanford Peng, MD PhD Alpine Immune Sciences
PRS Account Alpine Immune Sciences, Inc.
Verification Date August 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP