A Dose Escalation Study of AV-380 in Metastatic Cancer Patients With Cachexia
Cachexia
About this trial
This is an interventional treatment trial for Cachexia
Eligibility Criteria
Inclusion Criteria: Patient must be ≥ 18 years of age at the time of signing the informed consent. Patients with histologically confirmed metastatic CRC or pancreatic cancer, who are actively receiving SoC chemotherapy in the first line setting for metastatic disease; eligible patients must have completed at least 2 Cycles of chemotherapy to eligible: CRC patients who are receiving FOLFOX/FOLFOXIRI ± bevacizumab Pancreatic cancer patients who are receiving FOLFOX/FOLFIRINOX Patients with cachexia as defined by Fearon criteria: Weight loss > 5% over past 6 months (in absence of simple starvation), or BMI < 20 kg/m2 and any degree of weight loss > 2%, or Sarcopenia and any degree of weight loss > 2% Patients with life expectancy ≥ 3 months Exclusion Criteria: Significant clinical manifestation of any allergic, dermatological, hepatic, renal, hematological, pulmonary, metabolic, cardiovascular, gastrointestinal, neurological, or psychiatric disorders (e.g., anorexia nervosa). Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and/or surgery (including radiosurgery) and stable for at least 2 weeks before first dose of study treatment. Significant cardiovascular disease, including myocardial infarction within 3 months prior to start of protocol therapy. Corrected QT interval calculated by the Fridericia formula (QTcF) > 460 ms within the Screening period prior to the first dose of study treatment.
Sites / Locations
- Piedmont Cancer InstituteRecruiting
- New York Cancer and Blood SpecialistsRecruiting
- New York Cancer and Blood SpecialistsRecruiting
- New York Cancer and Blood SpecialistsRecruiting
- University Hospitals Cleveland Medical CenterRecruiting
- Summit Cancer CentersRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Experimental
Experimental
Experimental
Experimental
Experimental
Cohort 1
Cohort 2
Cohort 3
Cohort 4
Cohort 5
IV infusion of AV-380. 7 doses will be given -- the 2nd dose will be 28 days after the first dose, the remaining 5 doses will be given every 2 weeks.
IV infusion AV-380. This cohort will proceed at a new dose level with approval of the Dose Escalation Committee, after evaluation of data from the previous cohort. IV infusion AV-380. 7 doses will be given -- the 2nd dose will be 28 days after the first dose, the remaining 5 doses will be given every 2 weeks.
IV infusion AV-380. This cohort will proceed at a new dose level with approval of the Dose Escalation Committee, after evaluation of data from the previous cohort. IV infusion AV-380. 7 doses will be given -- the 2nd dose will be 28 days after the first dose, the remaining 5 doses will be given every 2 weeks.
IV infusion AV-380. This cohort will proceed at a new dose level with approval of the Dose Escalation Committee, after evaluation of data from the previous cohort. IV infusion AV-380. 7 doses will be given -- the 2nd dose will be 28 days after the first dose, the remaining 5 doses will be given every 2 weeks.
IV infusion AV-380. This cohort will proceed at a new dose level with approval of the Dose Escalation Committee, after evaluation of data from the previous cohort. IV infusion AV-380. 7 doses will be given -- the 2nd dose will be 28 days after the first dose, the remaining 5 doses will be given every 2 weeks.