Testing CCI-001 for cancer: recurrent and/or metastatic solid tumours

Inclusion

• +Unless otherwise noted, inclusion criteriaInclusion criteriaThe things you must have or be for a study to consider you.Read more → apply to all Parts of the protocolProtocolThe detailed plan a study must follow.Read more →.
• +Subject has provided informed consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more →/assent prior to initiation of any study-specific activities/procedures.
• +For Part 3, only patients of the following tumour types will be permitted to enroll: gynecologic cancers (ovarian, fallopian tube, cervical, endometrial, vulvar), pancreaticobiliary adenocarcinomas and others (lung adenocarcinoma, head and neck adenocarcinomas, transitional cell bladder cancer, and upper GI tumours \[including esophageal, gastroesophageal junction and stomach\]).
• +Patients must have measurable disease by Response Evaluation Criteria in Solid Tumours (RECIST) 1.1 criteria.
• +Age \>18 years.
• +Eastern Cooperative Oncology Group (ECOG) performance status (PS) \<1.
• +Life expectancy of greater than 12 weeks.
• +Patients must have normal organ and marrow function as defined below:
• +absolute neutrophil count ≥ 1.5 x 10˄9/L/L
• +hemoglobin ≥ 90 g/L
• +platelets ≥ 100 x 10˄9/L/L
• +total bilirubin ≤ 1.5 x Upper limit of normal (ULN)
• +AST (SGOT) and ALT(SGPT) ≤ 2.5 x ULN (≤ 5 x ULN for liver metastases)
• +Creatinine (Cr) ≤ 1.5 x ULN
• +All other laboratory assessments must be ≤ Grade 1 per Common Terminology Criteria for Adverse EventsAdverse eventAny medical problem that happens during a study, whether or not the treatment caused it.Read more → (CTCAE) v5.
• +Cardiac ejection fraction by echocardiogram must be \>50% for patients at baselineBaselineYour starting measurements, taken before treatment begins.Read more →. Any structural changes found must be reviewed by the treating investigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more → and deemed acceptable and safe prior to study enrolmentEnrolmentThe number of participants a study plans to include, or has included.Read more →. Any noted cardiac fibrosis will exclude a patient.
• +Baseline ECG with QTc ≤ 470 msec for females and ≤ 450 msec for men.
• +Ability and willingness to adhere to study-required procedures.
• +Agree to use adequate contraception (see Section 8.7) during the study and for 12 months after receiving the final dose of study drug.
• +Patients must have histologically or cytologically confirmed recurrent or metastatic solid tumours. For Part 1 and Part 2, patients must have disease progression on their last treatment, have exhausted available approved lines of therapy or better-characterized therapies that, at the discretion of the Investigator, are felt to be more appropriate therapy, or have malignancies for which there are no approved therapies. For Part 3, patients must have disease progression on their last treatment and have been treated with up to 3 approved lines of chemotherapy.
• +For Part 3, patients' tumours must be deemed to be sensitive to the planned chemotherapy regimens (gemcitabine for pancreaticobiliary adenocarcinomas carboplatin for lung adenocarcinomas and gemcitabine or carboplatin for gynecologic cancers) to be allowed to enroll in the study.
• +Four weeks must have elapsed since prior chemotherapy, hormonal therapy, targeted therapy, or radiation therapy. There is no restriction in the amount of bone marrow previously radiated.
• +Recovery to baseline or Grade 1 for all drug-related toxicities due to prior chemotherapy, radiation, hormonal therapy, or molecular targeted therapy, except for alopecia, nausea, diarrhea and constipation.