Clinical Trials /

ALPN-202 With PD-1 Inhibition in Advanced Malignancies



This is a cohort-based, open-label dose escalation and expansion study in adults with advanced solid tumors or lymphoma.

Related Conditions:
  • Hodgkin Lymphoma
  • Malignant Solid Tumor
  • Non-Hodgkin Lymphoma
Recruiting Status:



Phase 1

Trial Eligibility



  • Brief Title: ALPN-202 With PD-1 Inhibition in Advanced Malignancies
  • Official Title: An Open-label Study of ALPN-202 Combined With PD-1 Inhibition in Subjects With Advanced Malignancies (NEON-2)

Clinical Trial IDs

  • NCT ID: NCT04920383


  • Advanced Solid Tumor
  • Lymphoma


ALPN-202Dose Escalation and Expansion
PembrolizumabDose Escalation and Expansion


This is a cohort-based, open-label dose escalation and expansion study in adults with advanced solid tumors or lymphoma.

Trial Arms

Dose Escalation and ExpansionExperimentalALPN-202 + Pembrolizumab
  • ALPN-202
  • Pembrolizumab

Eligibility Criteria

        Inclusion Criteria:

          -  Adult 18 to 80 years old at screening

          -  Pathologically confirmed, locally advanced or metastatic unresectable solid tumor, or
             Hodgkin or Non-Hodgkin lymphoma (including transformed lymphoma) of an acceptable

               1. that is eligible for treatment with a PD-1 or PD-L1 inhibitor, or

               2. that is refractory or resistant to standard therapy, or

               3. for which standard or curative therapy is not available.

          -  Have received ≥ 2 prior systemic anti-cancer therapies (lymphoma subjects only)

          -  Protocol-defined measurable disease

          -  Available tumor biopsy representative of current disease

          -  ECOG performance status grade 0-1

          -  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

        Exclusion Criteria:

          -  Any history of ≥ Grade 3 immune-related adverse event (irAE)

          -  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:

               1. PD-L1 inhibitors: 5 half-lives (e.g., atezolizumab, 135 days; avelumab, 31 days;
                  durvalumab, 85 days)

               2. PD-1 inhibitors: one scheduled standard dosing interval

               3. Other checkpoint inhibitors, including CTLA-4 inhibitors (e.g., ipilimumab,
                  tremelimumab): 4 weeks

               4. Chemotherapy, small molecule anticancer agents (e.g., kinase inhibitors), or
                  radiation: 2 weeks

               5. 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, or or Severe Acute Respiratory Syndrome Coronavirus 2.

          -  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.
Maximum Eligible Age:80 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


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

Last Updated

July 28, 2021