Trial purpose
Cancer treatment
Tumor type
Multi-Cancer
Age
18 - 75
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 people with advanced solid cancers and refractory lymphoma
Eligibility
Inclusion
- 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)
- 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
Exclusion
- 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:
- 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.
Inclusion
- Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).
- Your cancer has not spread to other parts of the body (localised).
- You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
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.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:
Trial sponsor
Alpine Immune Sciences, Inc.
Scientific Title
An Open-label Study of ALPN-202 in Subjects With Advanced Malignancies (NEON-1)
Get Support
You might find it helpful to speak to someone who has 'been there before'. Our Peer Connect program can provide one-on-one phone support from someone who understands what you're going through and has clinical trials experience.
Know more about Peer Connect
If you need cancer information and practical support for yourself, a carer, family or friend, contact Cancer Council to speak with an experienced health professional on 13 11 20.
Get support
Learn more about clinical trials through this collection of resources in languages other than English.
View information