Clinical Trials /

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

NCT04186637

Description:

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.

Related Conditions:
  • Lymphoma
  • Malignant Solid Tumor
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

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

Clinical Trial IDs

  • ORG STUDY ID: AIS-B01
  • NCT ID: NCT04186637

Conditions

  • Advanced Solid Tumor
  • Lymphoma

Interventions

DrugSynonymsArms
ALPN-202Dose escalation and expansion

Purpose

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 Arms

NameTypeDescriptionInterventions
Dose escalation and expansionExperimentalALPN-202 0.001 - 20 mg/kg IV
  • ALPN-202

Eligibility Criteria

        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:

               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.
      
Maximum Eligible Age:75 Years
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Adverse events
Time Frame:Up to 30 days after last dose of study drug
Safety Issue:
Description:Type, incidence, and severity of adverse events as assessed by CTCAE

Secondary Outcome Measures

Measure:Objective response
Time Frame:Up to 30 days after last dose of study drug
Safety Issue:
Description:Best observed objective responses as assessed by RECIST for solid tumors, or Lugano for lymphoma

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Alpine Immune Sciences, Inc.

Last Updated

August 25, 2020