STIL101 for Injection for the Treatment of Locally Advanced, Metastatic or Unresectable Pancreatic Cancer, Colorectal Cancer, Renal Cell Cancer, Cervical Cancer and Melanoma

Inclusion Criteria

• •Documented informed consent of the participant and/or legally authorized representative.
• •* Assent, when appropriate, will be obtained per institutional guidelines
• •Agree to research biopsies while on-study
• •* Note: For research participants who do not speak English, a short form consent may be used with a City of Hope (COH) certified interpreter/translator to proceed with screening, while the request for a translated full consent is processed
• •Age: ≥ 18 years
• •Eastern Cooperative Oncology Group (ECOG) ≤ 1
• •Anticipated life expectancy of \> 6 months at the time of enrollment
• •Participants with pancreatic ductal adenocarcinoma (PDAC), colorectal cancer (CC), renal cell carcinoma (RCC), cervical cancer (CC) and melanoma, meeting the following criteria will be eligible:
• •* Cytologically or histologically confirmed locally advanced, unresectable, or metastatic PDAC, CRC, RCC, CC, melanoma
• •* Patients must have received at least 1 line of standard therapy prior to receiving STIL101 for injection. Note: Patients may be enrolled prior to starting treatment to harvest tumor and blood samples for tumor infiltrating lymphocyte (TIL) generation
• •* For pancreatic cancer patients:
• •* Patients on first line treatment will need to receive at least 4 months of standard chemotherapy before receiving STIL101 for injection
• •* In the second line setting, these patients may opt to receive STIL101 for injection at any time
• •* For melanoma cancer patients: Patients need to have received prior PD1 therapy and BRAF inhibitor treatment in patients with a V600E mutation
• •* For RCC, CRC, CC patients: Patients need to have failed at least 1 line of prior therapy
• •Measurable disease by RECIST 1.1
• •At least one lesion (or aggregate of lesions resected) that can be safety biopsied (excisional) and yield a volume (target of \> 1cm\^3) to generate STIL101 for injection (principal investigator \[PI\] discretion)
• •Absolute neutrophil count (ANC) ≥ 1,000/mm\^3
• •* NOTE: Growth factor is not permitted within 14 days of screening ANC assessment
• •Platelets ≥ 100,000/mm\^3
• •* NOTE: Platelet transfusions are not permitted within 14 days of screening platelet assessment
• •Hemoglobin ≥ 8 g/dL
• •* NOTE: Red blood cell transfusions are not permitted within 14 days of screening platelet assessment
• •Total bilirubin ≤ 2 x upper limit of normal (ULN) (unless participant has Gilbert's disease which allows total bilirubin ≤ 3 x ULN)
• •Aspartate aminotransferase (AST) ≤ 3 x ULN; ≤ 5.0 x ULN if hepatic metastases are present
• •Alanine transaminase (ALT) ≤ 3 x ULN; ≤ 5.0 x ULN if hepatic metastases are present
• •Creatinine clearance (CRCl) of ≥ 40 mL/min per 24-hour urine test or the Cockcroft-Gault formula
• •Oxygen (O2) saturation \> 92% on room air not requiring oxygen supplementation
• •* Note: To be performed within 28 days prior to start of protocol therapy
• •Left ventricular ejection fraction (LVEF) ≥ 50%
• •* Note: To be performed within 8 weeks prior to start of protocol therapy
• •If not receiving anticoagulants: International normalized ratio (INR) or prothrombin (PT) ≤ 1.5 x ULN. If on anticoagulant therapy: PT must be within therapeutic range of intended use of anticoagulants
• •If not receiving anticoagulants: Activated partial thromboplastin time (aPTT) ≤ 1.5 x ULN. If on anticoagulant therapy: aPTT must be within therapeutic range of intended use of anticoagulants
• •Seronegative for HIV antigen (Ag)/antibody (Ab) combo, hepatitis C virus (HCV), hepatitis B virus (HBV) (surface antigen negative), and syphilis (RPR)
• •* If seropositive for HCV or HBV, nucleic acid quantitation must be performed. Viral load must be undetected
• •QuantiFERON-TB Gold or equivalent
• •* Results do not impact patient eligibility; however, the test must be initiated prior to enrollment
• •Women of childbearing potential (WOCBP): negative urine or serum pregnancy test
• •* If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
• •Agreement by females and males of childbearing potential to use an effective method of birth control or abstain from heterosexual activity for the course of the study through at least 6 months after the last dose of protocol therapy
• •* Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for \> 1 year (women only)