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Advanced Solid TumorPhase 1NEON-2NCT04920383

ALPN-202 With PD-1 Inhibition in Advanced Malignancies

A Phase 1 study testing ALPN-202 and pembrolizumab KEYTRUDA® in people with Advanced Solid Tumor and Lymphoma, run by Alpine Immune Sciences, Inc. at 5 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

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

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Advanced Solid Tumor, Lymphoma
What is being tested?
ALPN-202 and pembrolizumab KEYTRUDA®
Could I receive a placebo?
No, everyone receives an active treatment
How many people
29 participants
Where
5 sitesUnited States
Study dates
22 Jun 2021to 28 Feb 2023
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
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  • 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

Who cannot join

  • 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:
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  • 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

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

United States5 sites

  • Investigational Site (213)

    Atlanta, Georgia, 30322

  • Investigational Site (212)

    Boston, Massachusetts, 02114

  • Investigational Site (301)

    Grand Rapids, Michigan, 49546

  • Investigational Site (203)

    Nashville, Tennessee, 37203

  • Investigational Site (215)

    San Antonio, Texas, 78229

Other trials in United States

About this study

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

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

Being tested
ALPN-202, pembrolizumab KEYTRUDA®
Medical subject headings
Lymphoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ALPN-202Drug

    Various doses

  • pembrolizumab KEYTRUDA®Drug

    Varies

Study groups in NCT04920383
Study groupRoleWhat they receive
Dose Escalation and ExpansionExperimentalALPN-202 + pembrolizumab KEYTRUDA®
Receives: Drug: ALPN-202; Drug: pembrolizumab KEYTRUDA®

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Dose-limiting Toxicities (DLTs)

    Incidence of DLTs

    Measured: Up to 6 weeks following study day 1

  2. Adverse Events (AEs)

    Type, incidence, severity, and seriousness of AEs

    Measured: 30 days after last dose of study drug

  3. Laboratory Abnormalities

    Type, incidence, and severity of laboratory abnormalities

    Measured: Up to 30 days after last dose of study drug

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jun 2021
  2. Study start22 Jun 2021
  3. Primary completion8 Nov 2022
  4. Study completion28 Feb 2023

Why it stopped: Sponsor decision

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
29 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04920383
Sponsor's protocol ID
AIS-B02
Other IDs
MK-3475-D05/KEYNOTE-D05
Acronym
NEON-2
Status last verified
Feb 2024
First submitted
3 Jun 2021
Last updated
1 Mar 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Cavalcante L, Chandana S, Lakhani N, Enstrom A, LeBlanc H, Schmalz J, Lengyel K, Schneider F, Thomas H, Chisamore MJ, Peng SL, Naumovski A, Davar D. Case report of fatal immune-mediated myocarditis following treatment with davoceticept (ALPN-202), a PD-L1-dependent CD28 costimulator and dual PD-L1/CTLA-4 checkpoint inhibitor, in combination with pembrolizumab. J Immunother Cancer. 2024 Aug 13;12(8):e009475. doi: 10.1136/jitc-2024-009475.

    PubMed 39142718

  • Davar D, Cavalcante L, Lakhani N, Moser J, Millward M, McKean M, Voskoboynik M, Sanborn RE, Grewal JS, Narayan A, Patnaik A, Gainor JF, Sznol M, Enstrom A, Blanchfield L, LeBlanc H, Thomas H, Chisamore MJ, Peng SL, Naumovski A. Phase I studies of davoceticept (ALPN-202), a PD-L1-dependent CD28 co-stimulator and dual PD-L1/CTLA-4 inhibitor, as monotherapy and in combination with pembrolizumab in advanced solid tumors (NEON-1 and NEON-2). J Immunother Cancer. 2024 Aug 3;12(8):e009474. doi: 10.1136/jitc-2024-009474.

    PubMed 39097413

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing ALPN-202 and pembrolizumab KEYTRUDA® in people with Advanced Solid Tumor and Lymphoma, run by Alpine Immune Sciences, Inc. at 5 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 1 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Sponsor decision). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose-limiting Toxicities (DLTs) (time frame: Up to 6 weeks following study day 1). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04920383, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2024.

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