Nab-Paclitaxel/STI-3031 Complex (AP160-Complex) for the Treatment of Advanced or Metastatic Solid Tumors

This phase I trial tests the safety, side effects, and best dose of a new drug called nab-paclitaxel/STI-3031 complex (AP160-complex) in treating patients with solid tumors that may have spread from where they first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) or that have spread from where they first started (primary site) to other distant parts of the body (metastatic). AP160-complex is a combination of the chemotherapy drug nab-paclitaxel, and the immunotherapy drug STI-3031. Nab-paclitaxel is in a class of medications called antimicrotubule agents. It works by stopping the growth and spread of tumor cells. Immunotherapy with monoclonal antibodies, such as STI-3031, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. AP160-complex may work better than standard therapies in treating advanced or metastatic solid tumors.

Inclusion Criteria:Provide written informed consentPRE-REGISTRATIONAge >= 18 yearsWillingness to provide mandatory pre-registration tissue specimen for researchAt least one prior systemic therapy in the metastatic setting (adjuvant or neoadjuvant therapy not included).NOTE: There is no upper limit to the number of prior treatment regimensDose Escalation Cohort OnlyPatients with histologically or cytologically confirmed advanced or metastatic non-neurological solid tumors, who have no curative or life prolonging therapeutic optionsMelanoma Dose Expansion Cohort OnlyHistologic proof of surgically unresectable stage IV malignant melanomaDisease progression on or after anti-PD1/PDL1 antibody-based therapy in the metastatic setting (adjuvant or neoadjuvant therapy with anti-PD1/PDL1 antibody do not count)REGISTRATIONTissue submitted for testing at pre-registration shows minimal level of tumor staining for PDL1 (clinical test using 22c3 immunohistochemistry) demonstrating tumor staining in >= 1% of tumor cellsEastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0, 1 or 2Hemoglobin >= 9.0 g/dL (patients may be transfused to meet hemoglobin [Hgb] requirement) (obtained =< 14 days prior to registration)Absolute neutrophil count (ANC) >= 1500/mm^3 (obtained =< 14 days prior to registration)Platelet count >= 100,000/mm^3 (obtained =< 14 days prior to registration)Total bilirubin =< 1.5 x upper limit of normal (ULN) or direct bilirubin =< 0.4 mg/dL (obtained =< 14 days prior to registration)Serum glutamic-oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) =< 2.5 x ULN or =< 5 x ULN in case of liver metastases (obtained =< 14 days prior to registration)Alkaline phosphatase =< 2.5 x ULN or =< 5 x ULN in case of liver metastases (obtained =< 14 days prior to registration)Calculated creatinine =< 1.5 x ULN or calculated creatinine clearance >= 45 ml/min using the Cockcroft-Gault formula for subjects with creatinine > 1.5 ULN (obtained =< 14 days prior to registration)Negative serum pregnancy test done =< 7 days prior to registration, for women of childbearing potential onlyNo motor peripheral neuropathySensory peripheral neuropathy =< Grade 1 (per Common Terminology Criteria for Adverse Events [CTCAE] 5.0)Immune-related adverse events (irAEs) from prior treatment have returned to baseline or =< Grade 1For persons of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use a contraceptive method with a failure rate of < 1% per year during the treatment period and for 6 months after the last dose of study treatmentFor person able to father a child: agreement to remain abstinent (refrain from heterosexual intercourse with a person of childbearing potential) or use contraceptive measures, and agreement to refrain from donating sperm during the treatment period and for 6 months after the last dose of study treatmentWillingness to provide mandatory blood specimens for correlative researchWillingness to provide mandatory tissue specimens for correlative researchWilling to return to enrolling institution for follow-up 2-4 weeks after treatment discontinuationLife expectancy >= 90 days (3 months)Dose Expansion Cohorts OnlyNOTE: Melanoma Dose Expansion cohort only planned for now. Availability to add other disease-specific dose expansion cohorts possible in future protocol amendments.Measurable disease defined as at least one lesion whose longest diameter can be accurately measured as >= 1.0cm with computed tomography (CT) scan or magnetic resonance imaging (MRI) scan; or CT component of a positron emission tomography (PET)/CT.NOTE: Disease that is measurable by physical examination only is not eligibleExclusion Criteria:Any of the following because this study involves an investigational agent whose genotoxic, mutagenic, and teratogenic effects on the developing fetus and newborn are unknown:Pregnant personsNursing personsPersons of childbearing potential {and persons able to father a child} who are unwilling to employ adequate contraceptionKnown standard therapy for the patient's disease that is potentially curative or definitely capable of extending life expectancyAny anti-cancer therapy or investigational agents =< 4 weeks prior to registrationFailure to recover from prior surgeryFailure to fully recover from acute, reversible effect of prior chemotherapy regardless of interval since last treatmentAnti-PD(L)1 antibody =< 4 weeks prior to registrationPrevious grade 4 irAEs from immune checkpoint inhibitor antibody therapyCo-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimensImmunocompromised patients and patients known to be human immunodeficiency virus (HIV) positive and currently receiving antiretroviral therapyNOTE: Patients known to be HIV positive, but without clinical evidence of an immunocompromised state, are eligible for this trialUncontrolled intercurrent illness including, but not limited to:ongoing or active infectionsymptomatic congestive heart failureunstable angina pectoriscardiac arrhythmiaor psychiatric illness/social situations that would limit compliance with study requirementsOther medical conditions including be not limited to:History of liver disease such as cirrhosis, chronic active hepatitis, chronic persistent hepatitis or hepatitis B or C.Active infection requiring parenteral antibioticsActive tuberculosis or active, non-infectious pneumonitisEvidence of interstitial lung diseaseNew York Heart Association class II-IV congestive heart failure (Serious cardiac arrhythmia requiring medication)Myocardial infarction or unstable angina =< 6 months prior to registrationCongestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmiasActive autoimmune disease such as Crohn's disease, rheumatoid arthritis, Sjogren's disease, systemic lupus erythematosus, or similar conditions requiring systemic therapy within the past 2 years with the use of disease modifying agents, corticosteroids, or immunosuppressants or a documented history of clinically severe autoimmune disease/syndrome difficult to control in the pastEXCEPTIONS (the following are allowed):Vitiligo or resolved childhood asthma/atopyIntermittent use of bronchodilators or local steroid injectionsNon-immunosuppressive maintenance treatments in the setting of clinically asymptomatic disease (e.g., sulfasalazine for ulcerative colitis)Hypothyroidism or hypoadrenalism, stable on hormone replacement,Diabetes stable with current managementHistory of positive Coombs's test but no evidence of hemolysisPsoriasis not requiring systemic treatmentConditions not expected to recur in the absence of an external triggerSecondary adrenal insufficiency from previous hypophysitis, currently on physiologic replacement steroid dosing onlyReceiving any other investigational agent which would be considered as a treatment for the primary neoplasmOther active malignancy =< 3 years prior to registration. Patients must not be receiving chemotherapy or immunotherapy for another cancer. Patients must not have another active malignancy requiring active treatmentEXCEPTIONS: Non-melanotic skin cancer or carcinoma-in-situ of the cervixNOTE: If there is a history of prior malignancy, they must not be receiving other specific treatmentNOTE: Early-stage cancer (stage 1/2, treated) should be allowedHistory of myocardial infarction =< 6 months, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmiasActive central nervous system (CNS) metastasisNOTE: Patients with prior brain metastases that are asymptomatic without corticosteroid use and stable or improved >= 30 days after treatment with surgery or radiation are not excludedCorticosteroid use =< 14 days prior to registration. NOTE: Patients must be off systemic corticosteroids for at least 2 weeks prior to registration. This includes oral or IV route of administration. Patients on chronic corticosteroids for adrenal insufficiency or other reasons may enroll if they receive less than 10 mg/day of prednisone (or equivalent). Patients receiving inhaled or intranasal or intraarticular steroids are not excludedEXCEPTIONS: Patients requiring steroid premedication for radiology contrast allergy are not excluded