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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT04186637
Other study ID # AIS-B01
Secondary ID
Status Terminated
Phase Phase 1
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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