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CompletedLast updated: 7 February 2024

NEON-1: This Phase I trial is evaluating a targeted therapy (ALPN-202) in people with advanced solid cancers, or refractory lymphoma.An Open-label Study of ALPN-202 in Subjects With Advanced Malignancies (NEON-1)

Clinical summary

Summary

This is an open-label dose escalation and expansion study in adults with advanced solid tumours or lymphoma, refractory or resistant to standard therapy, or without available standard or curative therapy. All participants will receive ALPN-202. Multiple dose levels and dose regimens will be administered.

Conditions

This trial is treating patients with advanced solid cancers and refractory lymphoma.

Cancer

Multi-Cancer Multi-Cancer

Age

People18 - 75

Phase

I

Trial Acronym

NEON-1

More information

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

Trial sponsor

Alpine Immune Sciences, Inc.

Scientific Title

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

Eligibility

Inclusion

  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

Exclusion

  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.

Inclusion

  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • Your cancer has not spread to other parts of the body.
  • Your cancer has spread to other parts of the body.

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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