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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT04186637




Registration number
NCT04186637
Ethics application status
Date submitted
27/11/2019
Date registered
5/12/2019
Date last updated
27/08/2020

Titles & IDs
Public title
An Open-label Study of ALPN-202 in Subjects With Advanced Malignancies
Scientific title
An Open-label Study of ALPN-202 in Subjects With Advanced Malignancies (NEON-1)
Secondary ID [1] 0 0
AIS-B01
Universal Trial Number (UTN)
Trial acronym
NEON-1
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced Solid Tumor 0 0
Lymphoma 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - ALPN-202

Experimental: Dose escalation and expansion - ALPN-202 0.001 - 20 mg/kg IV


Treatment: Drugs: ALPN-202
ALPN-202 0.001 - 20 mg/kg IV

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Adverse events - Type, incidence, and severity of adverse events as assessed by CTCAE
Timepoint [1] 0 0
Up to 30 days after last dose of study drug
Secondary outcome [1] 0 0
Objective response - Best observed objective responses as assessed by RECIST for solid tumors, or Lugano for lymphoma
Timepoint [1] 0 0
Up to 30 days after last dose of study drug

Eligibility
Key inclusion criteria
Key

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
Minimum age
18 Years
Maximum age
75 Years
Gender
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NedlandsVIC
Recruitment hospital [1] 0 0
Linear Research - Perth
Recruitment hospital [2] 0 0
Nucleus Network Pty Ltd - Melbourne
Recruitment postcode(s) [1] 0 0
6009 - Perth
Recruitment postcode(s) [2] 0 0
3004 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
Indiana
Country [3] 0 0
United States of America
State/province [3] 0 0
Michigan

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Alpine Immune Sciences, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT04186637
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Stanford Peng, MD PhD
Address 0 0
Alpine Immune Sciences
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
AIS-B01 Study Manager
Address 0 0
Country 0 0
Phone 0 0
+1-206-788-4545
Fax 0 0
Email 0 0
almudena.tercero@alpineimmunesciences.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT04186637