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An Open-label Study of ALPN-202 in Subjects With Advanced Malignancies | Clinical Trials | Clareo Health

TERMINATEDPHASE1

An Open-label Study of ALPN-202 in Subjects With Advanced Malignancies

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

NCT04186637•Alpine Immune Sciences, Inc.

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.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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
+5 more criteria

Exclusion Criteria

•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
+6 more criteria

Locations (10)

Investigational Site (004)

Scottsdale, Arizona, United States

Investigational Site (003)

New Haven, Connecticut, United States

Investigational Site (007)

Lafayette, Indiana, United States

Investigational Site (006)

Louisville, Kentucky, United States

Investigational Site (001)

Grand Rapids, Michigan, United States

Investigational Site (009)

Portland, Oregon, United States

Investigational Site (008)

Pittsburgh, Pennsylvania, United States

Investigational Site (102)

Perth, Nedlands, Australia

Investigational Site (101)

Melbourne, Victoria, Australia

Investigational Site (103)

Melbourne, Victoria, Australia

Key Dates

Start Date

June 2, 2020

Primary Completion Date

November 9, 2022

Completion Date

February 28, 2023

Last Updated

June 5, 2023

Enrollment

ACTUAL participants

Conditions

Advanced Solid TumorLymphoma

Interventions

ALPN-202

DRUG

Comparing Rituximab and Mosunetuzumab Drug Treatments for People With Low Tumor Burden Follicular Lymphoma

NCT06337318

Classic Follicular LymphomaFollicular Lymphoma With Unusual Cytological Features

View study

RECRUITINGPHASE1

A Study of PYX-201 in Advanced Solid Tumors

NCT05720117

Solid TumorAdvanced Solid Tumor

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 5, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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An Open-label Study of ALPN-202 in Subjects With Advanced Malignancies

Inclusion Criteria

Exclusion Criteria

Comparing Rituximab and Mosunetuzumab Drug Treatments for People With Low Tumor Burden Follicular Lymphoma

A Study of PYX-201 in Advanced Solid Tumors

A Study of Zilovertamab Vedotin (MK-2140) in Combination With Standard of Care in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (rrDLBCL) (MK-2140-003)

Phase II Study of Pirtobrutinib, Rituximab (PR) in Previously Untreated Low and Intermediate Risk MCL (Mantle Cell Lymphoma) Patients

Phase II Study of Pirtobrutinib With Venetoclax In Relapsed-Refractory MCL (Mantle Cell Lymphoma) Patients

A Study to Assess the Safety, Tolerability, and Efficacy of NDI-219216 in Patients With Advanced Solid Tumors.