-Has one of the following tumor types: melanoma, non-small cell lung cancer, or triple negative breast cancer

-Agrees to undergo a pre-treatment biopsy and another biopsy while on treatment

Expansion Inclusion Criteria specific to Melanoma:

-Histologically confirmed, unresectable Stage III or Stage IV melanoma, as specified in the American Joint Committee on Cancer staging system.

-Participants with ocular or uveal melanoma are ineligible.

-Must have documented progressive or recurrent disease on or after discontinuation of anti-PD-(L)1 therapy

Additional Inclusion Criteria for Phase 2 (Advanced Melanoma Patients)

-Participants who received anti-PD-(L)1 in the advanced/metastatic setting, must have documented progressive or recurrent disease on or within 3 months of discontinuation of anti-PD-(L)1 therapy

-Participants who received anti-PD-(L)1 in the adjuvant setting must have documented progressive or recurrent disease on or within 6 months of discontinuation of anti-PD-(L)1 therapy

-Disease progression was confirmed at least 4 weeks after the initial diagnosis of disease progression while receiving an anti PD-1 antibody.

-Participants with ocular or uveal melanoma are ineligible.

-Confirmation of radiographic progression on prior anti-PD-(L)1 therapy is required

-Prior treatment with rhIL2 or any recombinant long acting drug containing an IL2 moiety.

-Concurrent anticancer treatment (with the exception of palliative bone directed radiotherapy), immune therapy, or cytokine therapy (except for erythropoietin), major surgery (excluding prior diagnostic biopsy), concurrent systemic therapy with steroids or other immunosuppressive agents, or use of any investigational drug within 28 days before the start of study treatment.

-Previous malignant disease other than the current target malignancy within the last 3 years, with the exception of basal or squamous cell carcinoma of the skin, localized prostate cancer or cervical carcinoma in situ.

-Rapidly progressive disease.

-Any Grade 2 and higher neurological or pulmonary toxicity during a treatment with an anti-PD-1 or PD-L1 agent administered as a monotherapy.

-Active or history of central nervous system (CNS) metastases.

-Receipt of any organ transplantation, autologous or allogeneic stem-cell transplantation.

-Significant acute or chronic infections, or active or latent hepatitis B or active hepatitis C.

-Preexisting autoimmune disease needing treatment with systemic immunosuppressive agents for more than 28 days within the last 3 years, clinically relevant immunodeficiencies, or fever within 7 days of Day 1.

-Known severe hypersensitivity reactions to monoclonal antibodies and any history of anaphylaxis, or uncontrolled asthma

-Serious cardiac illness or medical conditions.

History of life-threatening toxicity related to prior immune therapy except those that are unlikely to re-occur with standard countermeasures.

Contacts and Locations