BXQ-350 in Newly Diagnosed Metastatic Colorectal Carcinoma

Inclusion Criteria

• •Participants who meet the following criteria will be considered eligible to participate in the clinical study:
• •1. Age ≥ 18 years of age at the time of signing the informed consent.
• •2. Participants have newly diagnosed Stage IV metastatic adenocarcinoma of the colon / rectum.
• •3. Have measurable disease at baseline based on RECIST 1.1 as determined by the local site Investigator / radiology assessment.
• •4. Have a life expectancy \> 3 months.
• •5. Have ECOG Performance Status of 0 or 1.
• •* Participants unable to walk because of paralysis, but who can sit without assistance/restraint and control a wheelchair, will be considered ambulatory for the purpose of assessing the performance score.
• •6. Have acceptable liver function defined as:
• •* Total serum bilirubin ≤ 1.5 x upper limit of normal (ULN) for the study site; in participants with known Gilbert Syndrome, total bilirubin ≤ 3 x ULN, with direct bilirubin ≤ 1.5 x ULN).
• •* Aspartate transaminase (AST), serum glutamic oxaloacetic transaminase (SGOT), alanine transaminase (ALT), serum glutamic pyruvic transaminase (SGPT) ≤ 3 x ULN (if liver metastases are present, then ≤ 5 x ULN is allowed).
• •* Serum albumin ≥ 3 g/ dL.
• •7. Have acceptable renal function defined as:
• •* Creatinine clearance ≥ 50 mL/minute calculated using the Cockcroft-Gault formula (Cockcroft 1976): CCr = {((140 - age) x weight kg) / (72 x SCr)} x 0.85 (if female).
• •* Urine dipstick protein \< 1 + (30 - 70 mg/dL), urine protein/creatinine ratio of \< 1, OR 24 hour urine protein \< 1g/24 hours.
• •8. Have acceptable bone marrow function defined as:
• •* Absolute neutrophil count ≥ 1,500 cells / mm3.
• •* Platelet count ≥ 100,000 cells / mm3 (unsupported, no transfusion within 7 days of enrollment).
• •* Hemoglobin \> 9.0 g/dL (unsupported, no transfusion within 7 days of enrollment).
• •9. Have acceptable coagulation parameters (anti-coagulation allowed) defined as:
• •* International normalized ratio ≤ 2 x ULN unless on anticoagulation or prothrombin time within normal limits.
• •* Activated partial thromboplastin time within normal limits.
• •10. Have a negative serum pregnancy test result at screening (females of childbearing potential \[FCBP\] only). Not applicable to participants who are surgically sterile (i.e., bilateral salpingectomy, bilateral oophorectomy, or complete hysterectomy) or who are post-menopausal. Women will be considered post-menopausal if they have been amenorrheic for 12 months without an alternative medical cause.
• •11. Contraceptive use by men and women must be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. FCBP whose partner(s) are non-sterilized males and non-sterilized male participants whose sexual partner(s) are FCBP must abstain from heterosexual activity or agree to use an acceptable method of contraception according to the following guidelines:
• •* The reliability of sexual abstinence for male and/or female enrollment eligibility needs to be evaluated in relation to the duration of the entire period of risk associated with study interventions and the preferred and usual lifestyle of the participant. Total sexual abstinence is an acceptable method provided it is the usual lifestyle of the participant. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or post ovulation methods), the rhythm method, and withdrawal are not acceptable methods of contraception.
• •* Non-sterilized Male Participants:
• •* Must use an acceptable method of contraception such as male condom plus spermicide during the entire period of risk associated with study interventions which includes the total duration of the study and the drug washout period (6 months after the last dose of study intervention) and refrain from sperm donation or banking throughout this period.
• •* Vasectomized males are considered fertile and should still use a male condom plus spermicide as indicated above.
• •* Even if the female partner is pregnant, male participants should still use a condom plus spermicide, as indicated above..
• •* Female partners (of childbearing potential) of male participants must also use a highly effective method of contraception during the entire period of risk associated with study interventions as described above.
• •* FCBP
• •* Must use a highly effective method of contraception and avoid breastfeeding during the entire period of risk associated with study interventions which includes the total duration of the study and the drug washout period (9 months after the last dose of study intervention) and refrain from egg donation or banking throughout this period.
• •* Non-sterilized male partners must also use a male condom plus spermicide during the entire period of risk associated with study interventions as described above.
• •* A highly effective method of contraception is defined as one that results in a low failure rate (less than 1% per year) when used consistently and correctly. Note that some contraception methods are not considered highly effective. The participants chosen method(s) must be confirmed as highly effective prior to study entry.
• •12. Participant is capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.