study to assess the safety and tolerability of repeated doses of an investigational new drug in patients with cancer and cachexia.

Conditions: Cachexia; Non-Small-Cell Lung Cancer; Pancreatic Cancer; Colorectal Cancer

Summary: study to assess the safety and tolerability of repeated doses of an investigational new drug in patients with cancer and cachexia.

this 12-week open-label study will explore how pf-06946860 is tolerated, the effects of the study drug, the best dose for treatment and how participants with non-small cell lung, pancreatic or colorectal cancer and cachexia feel after receiving repeated subcutaneous dosing. during the 12-week treatment period, study drug will be administered subcutaneously every 3 weeks for a total of 5 doses. there is a 12-week follow-up period following the last dose of study drug. additional assessments include: * body weight measurements * blood pressure and heart rate measurements * lumbar skeletal muscle index (lsmi) by ct scan * blood samples: * to evaluate safety, * to measure the amount of the study drug in the blood, * to evaluate if the study drug causes an immune response, * to examine the effects of the study drug on levels of a specific cytokine, * and for exploratory samples for bio banking. * measure the impact of the study drug on appetite, nausea, vomiting, fatigue, physical function, and health-related quality of life with questionnaires. * measure the impact of study drug on physical activity using wearable digital sensors. * to evaluate the effect of study drug on ability to complete anti-tumor treatment and survival in participants with cancer and cachexia. * to evaluate tumor size.

Eligibility criteria:
inclusion criteria: * documented histologic or cytologic diagnosis of advanced metastatic nsclc, advanced/unresectable pancreatic cancer, or metastatic colorectal cancer. * cachexia, defined by bmi \ 2% within 6 months prior to screening or involuntary weight loss of \>5% within 6 months prior to screening irrespective of bmi or if medical record documentation is unavailable, patient's report will suffice to estimate involuntary body weight loss.; * will receive the following for non-small cell lung cancer: * a platinum + pemetrexed ± pembrolizumab or * a platinum + nab paclitaxel or paclitaxel ± pembrolizumab or * pembrolizumab alone * will receive the following for pancreatic cancer: * folfirinox or * nab-paclitaxel + gemcitabine * gemcitabine * will receive the following for colorectal cancer: * folfox +/- biologic (bevacizumab or cetuximab/panitumumab) or * folfiri +/- biologic (bevacizumab or cetuximab/panitumumab) or * folfoxiri +/- biologic (bevacizumab or cetuximab/panitumumab) or * pembrolizumab for msi-h • will be entering the study at the first or second cycle of their current course of anti-cancer treatment/ therapy. * adequate renal and liver function. * signed informed consent. exclusion criteria: * all other forms of cancers not specified above unless currently considered cured (\>5 years without evidence of recurrence). * planned radiation therapy as part of the primary anti-tumor therapy regimen. however, localized radiation therapy for symptomatic relief is permitted * cachexia caused by other reasons: severe copd requiring use of home o2, heart failure or aids. * known symptomatic brain metastases requiring steroids. * active hepatitis b or c virus. * confirmed positive hiv test. * current active reversible causes of decreased food intake. * receiving tube feedings or parenteral nutrition at screening. * elevated blood pressure that cannot be controlled by medications. * women who are pregnant or breast-feeding

Keywords: cachexia, non-small cell lung cancer, pancreatic cancer colorectal cancer, weight loss, anorexia, muscle loss, fatigue