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

Lymphoma Clinical Trial

— NEON-1  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04186637
• Other study ID #: AIS-B01
• Status: Terminated
• Phase: Phase 1
• Start date: June 2, 2020
• Est. completion date: February 28, 2023

Study information

• Verified date: June 2023
• Source: Alpine Immune Sciences, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 62
• Est. completion date: February 28, 2023
• Est. primary completion date: November 9, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Advanced Solid Tumor
• Lymphoma
• Neoplasms

Intervention

Drug:
• ALPN-202
Multiple dose levels and dose regimens of ALPN-202 will be administered

Locations

Country	Name	City	State
Australia	Investigational Site (101)	Melbourne	Victoria
Australia	Investigational Site (103)	Melbourne	Victoria
Australia	Investigational Site (102)	Perth	Nedlands
United States	Investigational Site (001)	Grand Rapids	Michigan
United States	Investigational Site (007)	Lafayette	Indiana
United States	Investigational Site (006)	Louisville	Kentucky
United States	Investigational Site (003)	New Haven	Connecticut
United States	Investigational Site (008)	Pittsburgh	Pennsylvania
United States	Investigational Site (009)	Portland	Oregon
United States	Investigational Site (004)	Scottsdale	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Alpine Immune Sciences, Inc.

Countries where clinical trial is conducted

United States,  Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse Events	Type, incidence, and severity of adverse events as assessed by CTCAE	Up to 30 days after last dose of study drug
Secondary	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