FID-007 in Treating Participants With Advanced Solid Tumors

Inclusion Criteria

• •Patients must have histopathologically /cytologically confirmed advanced solid tumor which is refractory to standard therapeutic options, or for which there are no standard therapeutic options, or for whom paclitaxel is an appropriate palliative treatment option (patients for whom paclitaxel or nab-paclitaxel are established treatment options with a proven survival benefit in first line will be excluded)
• •Patients must have Eastern Cooperative Oncology Group (ECOG) performance status ? 2
• •Patient must have recovered from any toxic effects of previous chemotherapy, targeted therapy or radiotherapy as judged by the investigator to ? grade 1
• •Previous chemotherapy/radiotherapy/targeted therapy should have been completed at least 4 weeks prior to start of FID-007 administration
• •Patients must have an estimated life expectancy of at least 3 months
• •Female patients of child bearing potential must have negative serum pregnancy test at screening
• •Sexually active women, unless surgically sterile (at least 6 months prior to study drug administration) or postmenopausal for at least 12 consecutive months, must use an effective method of avoiding pregnancy (including oral, transdermal, or implanted contraceptives \[any hormonal method in conjunction with a secondary method\], intrauterine device, female condom with spermicide, diaphragm with spermicide, absolute sexual abstinence, use of condom with spermicide by sexual partner or sterile \[at least 6 months prior to study drug administration\] sexual partner) for at least 4 weeks prior to study drug administration, during study and up to 30 days or till next chemotherapy cycle; cessation of birth control after this point should be discussed with a responsible physician; investigator will discuss with patient on the above points and the patient agreement will be documented in the source document; the investigator should ensure that the patient is using an effective method of avoiding pregnancy as per protocol; in case of male patients: either patient partners or patients themselves must use an effective method of avoiding pregnancy for at least 4 weeks prior to study drug administration, during study and up to 30 days or till next chemotherapy cycle
• •Patients must agree, as part of the informed consent, to provide blood for pharmacokinetics analysis
• •Absolute neutrophil count (ANC) ? 1500/mm\^3
• •Platelet count ? 100,000/mm\^3
• •Hemoglobin ? 8 g/dL
• •Serum creatinine ? 1.5 X upper limit of normal (ULN) OR calculated clearance ? 50 mL/min/1.73 m\^2; if using creatinine clearance, actual body weight should be used for calculating creatinine clearance (e.g., using the Cockcroft-Gault formula); for subjects with a body mass index (BMI) \> 30 kg/m\^2, lean body weight should be used instead
• •Total bilirubin ? 1 X ULN (subjects with Gilbert?s disease can have bilirubin of up to 1.5 X ULN)
• •Aspartate aminotransferase (AST) / alanine aminotransferase (ALT) \< 3 X ULN
• •Patients in the dose escalation phase of the study must have measurable or evaluable disease according to RECIST 1.1 criteria