Advanced Solid TumorPhase 1NEON-1NCT04186637
An Open-label Study of ALPN-202 in Subjects With Advanced Malignancies
A Phase 1 study testing ALPN-202 in people with Advanced Solid Tumor and Lymphoma, run by Alpine Immune Sciences, Inc. at 10 sites in 2 countries.
Trial summary
This is a cohort-based, open-label dose escalation and expansion study in adults with advanced solid tumors or lymphoma, refractory or resistant to standard therapy, or without available standard or curative therapy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Solid Tumor, Lymphoma
- What is being tested?
- ALPN-202
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 10 sitesin 2 countries
- Study dates
- 2 Jun 2020to 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult 18 to 75 years old at screening
- Pathologically-confirmed, locally advanced or metastatic unresectable solid tumor of an acceptable histology
- Part A (Dose Escalation)
- that is refractory or resistant to standard therapy, including checkpoint inhibitor(s) if approved
- or for which standard or curative therapy is not available
- Part B (Dose Expansion)
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- metastatic cutaneous melanoma
- PD-L1-positive cancers (other than cutaneous melanoma or renal cell carcinoma)
- metastatic renal cell carcinoma
- 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
Who cannot join
- History of ≥ Grade 3 immune-related adverse event leading to treatment discontinuation
- 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:
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- 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.
Trial locations and contacts
10 sites in 2 countries.
10 sites in 2 countries
United States7 sites
Investigational Site (001)
Grand Rapids, Michigan, 49546
Investigational Site (007)
Lafayette, Indiana, 47905
Investigational Site (006)
Louisville, Kentucky, 40202
Investigational Site (003)
New Haven, Connecticut, 06520
Investigational Site (008)
Pittsburgh, Pennsylvania, 15232
Investigational Site (009)
Portland, Oregon, 97213
Investigational Site (004)
Scottsdale, Arizona, 85258
Australia3 sites
Investigational Site (101)
Melbourne, Victoria, 3004
Investigational Site (103)
Melbourne, Victoria, 3004
Investigational Site (102)
Perth, Nedlands, 6009
About this study
Official title: An Open-label Study of ALPN-202 in Subjects With Advanced Malignancies (NEON-1)
This is a cohort-based, open-label dose escalation and expansion study in adults with advanced solid tumors or lymphoma, refractory or resistant to standard therapy, or without available standard or curative therapy.
- Conditions
- Advanced Solid Tumor, Lymphoma
- Being tested
- ALPN-202
- 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
Multiple dose levels and dose regimens of ALPN-202 will be administered
| Study group | Role | What they receive |
|---|---|---|
| Dose escalation and expansion | Experimental | ALPN-202 Receives: Drug: ALPN-202 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events
Type, incidence, and severity of adverse events as assessed by CTCAE
Measured: Up to 30 days after last dose of study drug
Secondary outcomes (1)
Objective response
Best observed objective responses as assessed by RECIST for solid tumors, or Lugano for lymphoma
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.
- First posted5 Dec 2019
- Study start2 Jun 2020
- Primary completion9 Nov 2022
- Study completion28 Feb 2023
Why it stopped: Sponsor decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Advanced Solid TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alpine Immune Sciences, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Allison Naumovski, Ph.D., Study director, Alpine Immune Sciences, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04186637
- Sponsor's protocol ID
- AIS-B01
- Acronym
- NEON-1
- Status last verified
- Jun 2023
- First submitted
- 27 Nov 2019
- Last updated
- 5 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
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
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label Study of ALPN-202 in Subjects With Advanced Malignancies (NEON-1)
- ClinicalTrials.gov ID
- NCT04186637
- Acronym / sponsor ID
- NEON-1 / AIS-B01
- Conditions
- Advanced Solid Tumor, Lymphoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor decision
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Alpine Immune Sciences, Inc.Industry (pharma, biotech, devices)
- Study start
- 2 Jun 2020 (actual)
- Primary completion
- 9 Nov 2022 (actual)
- Study completion
- 28 Feb 2023 (actual)
- First posted
- 5 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a cohort-based, open-label dose escalation and expansion study in adults with advanced solid tumors or lymphoma, refractory or resistant to standard therapy, or without available standard or curative therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dose escalation and expansion | Experimental | Drug: ALPN-202ALPN-202 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Adult 18 to 75 years old at screening
- Pathologically-confirmed, locally advanced or metastatic unresectable solid tumor of an acceptable histology
- Part A (Dose Escalation)
- Part B (Dose Expansion)
- Protocol-defined measurable disease
Key exclusion criteria (16 listed)
- History of ≥ Grade 3 immune-related adverse event leading to treatment discontinuation
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ALPN-202Multiple dose levels and dose regimens of ALPN-202 will be administered | Drug | Dose escalation and expansion |
Primary outcome
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
1 secondary outcome
Objective response
Time frame: Up to 30 days after last dose of study drug
Results and safety
The study was stopped early (reason given: Sponsor decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2023.
- Derived from this study: PubMed 39097413Davar 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Allison Naumovski, Ph.D. study director
Alpine Immune Sciences, Inc.
10 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ALPN-202 in people with Advanced Solid Tumor and Lymphoma, run by Alpine Immune Sciences, Inc. at 10 sites in 2 countries.
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 15 inclusion and 16 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 5 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States, Australia. 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?
Adverse Events (time frame: Up to 30 days after last dose of study drug). 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 NCT04186637, which also lists 1 linked publication.
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 5 Jun 2023.