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

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

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.

Study Overview

• Status: Terminated
• Conditions: Lymphoma; Advanced Solid Tumor
• Intervention / Treatment: Drug: ALPN-202

• Study Type: Interventional
• Enrollment (Actual): 62
• Phase: Phase 1

Contacts and Locations

Study Locations

• Australia
  • Nedlands
    • Perth, Nedlands, Australia, 6009
      • Investigational Site (102)
  • Victoria
    • Melbourne, Victoria, Australia, 3004
      • Investigational Site (101)
    • Melbourne, Victoria, Australia, 3004
      • Investigational Site (103)
• United States
  • Arizona
    • Scottsdale, Arizona, United States, 85258
      • Investigational Site (004)
  • Connecticut
    • New Haven, Connecticut, United States, 06520
      • Investigational Site (003)
  • Indiana
    • Lafayette, Indiana, United States, 47905
      • Investigational Site (007)
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • Investigational Site (006)
  • Michigan
    • Grand Rapids, Michigan, United States, 49546
      • Investigational Site (001)
  • Oregon
    • Portland, Oregon, United States, 97213
      • Investigational Site (009)
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15232
      • Investigational Site (008)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 73 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Events	Type, incidence, and severity of adverse events as assessed by CTCAE	Up to 30 days after last dose of study drug

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective response	Best observed objective responses as assessed by RECIST for solid tumors, or Lugano for lymphoma	Up to 30 days after last dose of study drug

Collaborators and Investigators

• Sponsor: Alpine Immune Sciences, Inc.
• Investigators: Study Director: Allison Naumovski, Ph.D., Alpine Immune Sciences, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): June 2, 2020
• Primary Completion (Actual): November 9, 2022
• Study Completion (Actual): February 28, 2023

Study Registration Dates

• First Submitted: November 27, 2019
• First Submitted That Met QC Criteria: December 2, 2019
• First Posted (Actual): December 5, 2019

Study Record Updates

• Last Update Posted (Actual): June 5, 2023
• Last Update Submitted That Met QC Criteria: June 2, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: AIS-B01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No