An Open-label Study of ALPN-202 in Subjects With Advanced Malignancies (NEON-1)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT04186637 |
Recruitment Status :
Recruiting
First Posted : December 5, 2019
Last Update Posted : October 28, 2021
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Advanced Solid Tumor Lymphoma | Drug: ALPN-202 | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 102 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | An Open-label Study of ALPN-202 in Subjects With Advanced Malignancies (NEON-1) |
Actual Study Start Date : | June 2, 2020 |
Estimated Primary Completion Date : | December 2024 |
Estimated Study Completion Date : | December 2024 |

Arm | Intervention/treatment |
---|---|
Experimental: Dose escalation and expansion
ALPN-202
|
Drug: ALPN-202
Multiple dose levels and dose regimens of ALPN-202 will be administered |
- Adverse events [ Time Frame: Up to 30 days after last dose of study drug ]Type, incidence, and severity of adverse events as assessed by CTCAE
- Objective response [ Time Frame: Up to 30 days after last dose of study drug ]Best observed objective responses as assessed by RECIST for solid tumors, or Lugano for lymphoma

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Key Inclusion Criteria:
- Adult 18 to 75 years old at screening
- 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
- 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 0-2
- 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:
- 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:
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04186637
Contact: Joan Ignosci | (973) 574-6159 | IgnosciJoan@prahs.com |
United States, Arizona | |
Honor Health | Recruiting |
Scottsdale, Arizona, United States, 85258 | |
United States, Connecticut | |
Smilow Cancer Hospital at Yale New Haven | Recruiting |
New Haven, Connecticut, United States, 06520 | |
United States, Indiana | |
Horizon Oncology | Recruiting |
Lafayette, Indiana, United States, 47905 | |
United States, Kentucky | |
Norton Cancer Institute | Recruiting |
Louisville, Kentucky, United States, 40202 | |
United States, Michigan | |
START Midwest | Recruiting |
Grand Rapids, Michigan, United States, 49546 | |
United States, Oregon | |
Providence Cancer Institute Franz Clinic | Recruiting |
Portland, Oregon, United States, 97213 | |
United States, Pennsylvania | |
UPMC Hillman Cancer Center | Recruiting |
Pittsburgh, Pennsylvania, United States, 15232 | |
Australia, Nedlands | |
Linear Research | Recruiting |
Perth, Nedlands, Australia, 6009 | |
Australia, Victoria | |
Nucleus Network Pty Ltd | Active, not recruiting |
Melbourne, Victoria, Australia, 3004 | |
The Alfred | Recruiting |
Melbourne, Victoria, Australia, 3004 |
Study Director: | Stanford Peng, MD, PhD | Alpine Immune Sciences, Inc. |
Responsible Party: | Alpine Immune Sciences, Inc. |
ClinicalTrials.gov Identifier: | NCT04186637 |
Other Study ID Numbers: |
AIS-B01 |
First Posted: | December 5, 2019 Key Record Dates |
Last Update Posted: | October 28, 2021 |
Last Verified: | October 2021 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Neoplasms |