Galinpepimut-S in Combination With Pembrolizumab in Patients With Selected Advanced Cancers

Inclusion Criteria

• Is willing and able to understand and provide signed informed consent for the study that fulfills IRB guidelines
• Male or female patients >18 years of age on the day of signing informed consent
• Histologically or cytologically-confirmed advanced or metastatic solid tumors who have disease progression after treatment with available therapies for metastatic disease that are known to confer clinical benefit, or are intolerant to treatment, or refuse standard treatment in the context of the particular line of treatment or, specifically for AML, demonstrate as their best response after 4 cycles of HMA therapy the status of "partial response" per European LeukemiaNet (ELN) criteria and meet the additional specified requirements for the cohort of the study they will enroll into.
• All patients in the solid tumor arms will be tested for WT1 expression via IHC in their initial primary tumor OR recent biopsy of metastatic disease at the time of screening for study entry. Specifically for AML, patients will be tested for WT1 expression via IHC in their leukemic blasts either in the BM or PB. Assessment of WT1 expression positivity will be performed via central review prior to study entry.
• Patients may have received a specific maximum allowable number of prior lines of therapy for metastatic disease, as follows: CRC: 2 or 3 lines; OvC: 1 or 2 lines; SCLC: 1 line; TNBC: 1 line; and AML: 1 line (allo-SCT-eligible status not allowed)
• For solid tumor arms: patients must measurable disease based on RECIST v1.1 as determined by the local study team.
• For AML arm, eligibility is defined as:
• Prior frontline (1st line) with HMAs since initial AML diagnosis;
• Prior cytoreductive therapy with hydroxyurea or leukapheresis at the time of initial diagnosis, with subsequent immediate seamless transitioning to HMA therapy
• History of induction early failure after initial therapy with up to 2 cycles of standard chemotherapy ("7+3" or similar regimen), with subsequent immediate seamless transitioning to HMA therapy as long as patients have achieved PR as their best observable response after 4 cycles of HMA therapy; HMA therapy continues throughout the trial period.
• Resolution of toxicity effect(s) from most recent prior chemotherapy to Grade 1 or less (except alopecia). If the patient received major surgery or radiation therapy of > 30 Gy, they must have recovered from the toxicity and/or complications from the intervention.
• (ECOG) performance status of 0 or 1.
• For women of child-bearing potential, agreement to use adequate birth control (abstinence, hysterectomy, bilateral oophorectomy, bilateral tubal ligation, oral contraception, IUD, or use of condoms or diaphragms)
• Male patients of childbearing potential must agree to use an adequate method of contraception, starting with the first dose of study therapy through 4 months following the last study treatment.
• Have adequate organ function as defined:
• Absolute neutrophil count (ANC) ≥1500/µL
• Platelets ≥100,000/µL
• Hemoglobin (Hb) ≥9.0 g/dL or ≥5.6 mmol/L (N.B.: Hb criterion must be met without erythropoietin dependency and without packed red blood cell transfusion within last 2 weeks)
• Creatinine ≤1.5 × upper limit of normal (ULN) OR Measured or calculated creatinine clearance (GFR can also be used in place of creatinine or CrCl) ≥30 mL/min for subjects with creatinine levels >1.5 × institutional ULN
• Total bilirubin ≤1.5 ×ULN OR direct bilirubin ≤ULN for subjects with total bilirubin levels >1.5 × ULN
• AST (SGOT) and ALT (SGPT) ≤2.5 × ULN OR ≤5 × ULN for subjects with liver metastases
• International normalized ratio (INR) OR prothrombin time (PT) and Activated partial thromboplastin time (aPTT) ≤1.5 × ULN, unless subjects are receiving anticoagulant therapy as long as PT or aPTT is within the therapeutic range of intended use of anticoagulants

Additional Inclusion Criteria for Selected Tumor Types:

(i).Colorectal Cancer (third/fourth line)

• Hist