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

Sponsor
Alpine Immune Sciences, Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04186637
Collaborator
(none)
102
Enrollment
10
Locations
1
Arm
54
Anticipated Duration (Months)
10.2
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

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
Phase 1

Study Design

Study Type:
Interventional
Anticipated 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 :
Jun 2, 2020
Anticipated Primary Completion Date :
Dec 1, 2024
Anticipated Study Completion Date :
Dec 1, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Adverse events [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 [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

Criteria

Ages Eligible for Study:
18 Years to 75 Years
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, 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:

  7. PD-L1 inhibitors: 5 half-lives (e.g., atezolizumab, 135 days; avelumab, 31 days; durvalumab, 85 days)

  8. Chemotherapy, small molecule anticancer agents (e.g., kinase inhibitors), or radiation: 2 weeks

  9. Other monoclonal antibodies, antibody-drug conjugates, bispecific antibodies, antibody like drugs, cytokines, cell therapies, or radioimmunoconjugates: 4 weeks

  10. Any active, known, or suspected autoimmune disease

  11. Systemic treatment with corticosteroids (> 10 mg/day prednisone) or other immunosuppressive medication

  12. Any second malignancy active within the previous 3 years

  13. Active infection requiring therapy at the time of the first dose of ALPN-202.

  14. Known seropositivity for or active infection by human immunodeficiency virus, hepatitis B or C.

  15. Known allergies, hypersensitivity, or intolerance to ALPN-202 or excipients in the drug product formulation.

  16. History of Grade 4 infusion-related, anaphylactic or allergic reaction to any previous Fc-based protein therapy.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Honor Health Scottsdale Arizona United States 85258
2 Smilow Cancer Hospital at Yale New Haven New Haven Connecticut United States 06520
3 Horizon Oncology Lafayette Indiana United States 47905
4 Norton Cancer Institute Louisville Kentucky United States 40202
5 START Midwest Grand Rapids Michigan United States 49546
6 Providence Cancer Institute Franz Clinic Portland Oregon United States 97213
7 UPMC Hillman Cancer Center Pittsburgh Pennsylvania United States 15232
8 Linear Research Perth Nedlands Australia 6009
9 Nucleus Network Pty Ltd Melbourne Victoria Australia 3004
10 The Alfred Melbourne Victoria Australia 3004

Sponsors and Collaborators

  • Alpine Immune Sciences, Inc.

Investigators

  • Study Director: Stanford Peng, MD, PhD, Alpine Immune Sciences, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Alpine Immune Sciences, Inc.
ClinicalTrials.gov Identifier:
NCT04186637
Other Study ID Numbers:
  • AIS-B01
First Posted:
Dec 5, 2019
Last Update Posted:
Oct 28, 2021
Last Verified:
Oct 1, 2021
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Neoplasms

Study Results

No Results Posted as of Oct 28, 2021