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

Study Overview
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Brief Summary
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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.

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

Conditions
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Advanced Solid Tumor, Lymphoma

Intervention / Treatment
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* Drug: ALPN-202


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: Adult 18 to 75 years old at screening Pathologically-confirmed, locally advanced or metastatic unresectable solid tumor of an acceptable histology Part A (Dose Escalation) that is refractory or resistant to standard therapy, including checkpoint inhibitor(s) if approved or for which standard or curative therapy is not available Part B (Dose Expansion) metastatic cutaneous melanoma PD-L1-positive cancers (other than cutaneous melanoma or renal cell carcinoma) metastatic renal cell carcinoma Protocol-defined measurable disease Available tumor biopsy representative of current disease ECOG performance status grade 0-2 Life expectancy of ≥ 3 months 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) Adequate baseline hematologic, renal, and hepatic function Key Exclusion Criteria: History of ≥ Grade 3 immune-related adverse event leading to treatment discontinuation Active or prior pneumonitis or interstitial lung disease Presence of any active central nervous system metastases Prior organ allograft or allogeneic hematopoietic stem cell transplantation 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. Receipt of any protocol-restricted therapy within the timeframes indicated: PD-L1 inhibitors: 5 half-lives (e.g., atezolizumab, 135 days; avelumab, 31 days; durvalumab, 85 days) Chemotherapy, small molecule anticancer agents (e.g., kinase inhibitors), or radiation: 2 weeks Other monoclonal antibodies, antibody-drug conjugates, bispecific antibodies, antibody like drugs, cytokines, cell therapies, or radioimmunoconjugates: 4 weeks Any active, known, or suspected autoimmune disease Systemic treatment with corticosteroids (> 10 mg/day prednisone) or other immunosuppressive medication Any second malignancy active within the previous 3 years Active infection requiring therapy at the time of the first dose of ALPN-202. Known seropositivity for or active infection by human immunodeficiency virus, hepatitis B or C. Known allergies, hypersensitivity, or intolerance to ALPN-202 or excipients in the drug product formulation. History of Grade 4 infusion-related, anaphylactic or allergic reaction to any previous Fc-based protein therapy.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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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 |