ALPN-202 With PD-1 Inhibition in Advanced Malignancies

Stopped early · Phase 1

Conditions studied: Advanced Solid Tumor, Lymphoma

In brief

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

Key facts

Study ID: NCT04920383
Run by: Alpine Immune Sciences, Inc.
People needed: 29
Starts: 2021-06-22
Expected to finish: 2023-02-28
Last updated by the study team: 2024-03-01

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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 histology:
that is eligible for treatment with a PD-1 or PD-L1 inhibitor, or
that is refractory or resistant to standard therapy, or
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, hepatic and cardiac function

You may not qualify if…

Any history of ≥ Grade 3 immune-related adverse event (irAE) requiring discontinuation from treatment or any history of a cardiovascular 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 other 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:
Checkpoint inhibitors, including PD-(L)1 (e.g., pembrolizumab, nivolumab, cemiplimab, avelumab, durvalumab), CTLA-4 (e.g., ipilimumab, tremelimumab), and Lag-3 (e.g., relatlimab), costimulatory agonists (including but not limited to CD28, CD134 (OX40), CD137 (4-1BB)): 3 months (135 days for atezolizumab)
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, 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.
Any serious or uncontrolled cardiovascular condition, including but not limited to:
Any history of myocarditis of any etiology
History of New York Heart Association Class III or IV congestive heart failure, myocardial infarction, unstable angina, cerebrovascular accident, cardiac hospitalization, or other acute uncontrolled heart disease within 6 months of scheduled C1D1
Left ventricular ejection fraction < 45% on screening echocardiogram
Any clinically significant findings on screening EKG such as atrial or ventricular arrythmia (other than sinus tachycardia) or AV conduction abnormality such as left bundle branch block (such subjects may be enrolled after cardiology clearance and Medical Monitor approval)
Has received prior radiotherapy within 2 weeks of start of study treatment, or have had a history of radiation pneumonitis

Where it is running

Investigational Site (213) — Atlanta, Georgia, United States
Investigational Site (212) — Boston, Massachusetts, United States
Investigational Site (301) — Grand Rapids, Michigan, United States
Investigational Site (203) — Nashville, Tennessee, United States
Investigational Site (215) — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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