Master Protocol for the Study of Rilogrotug for the Treatment of Weight Loss and Anorexia in Patients With Cancer Cachexia and mCRC or mNSCLC

Criteria the registry did not label

• Phase 2 (A), Phase 3 (B) \& (C) Inclusion Criteria (IC):
• Documented histological or cytological confirmation of either mNSCLC or mCRC
• For patients with mNSCLC, receiving first line (1L) systemic anticancer standard of care (SOC) treatment with standard approved regimens: the 1L systemic anticancer SOC treatments are a platinum-based doublet chemotherapy regimen, and an anti-PD-(L)1 immunotherapy
• For patients with mCRC, receiving 1L systemic anticancer SOC treatment with standard approved regimens: fluorouracil-based regimens including oxaliplatin or irinotecan with or without biologics)
• Documentation of informed consent by the patient or the patient's legally acceptable representative, indicating that the patient has been informed of and comprehended all pertinent aspects of the trial
• Is willing and able to comply with the protocol tests and procedures
• Age ≥18 years
• Cachexia as defined by Fearon criteria for body weight and body mass index (BMI) (Fearon 2011)
• Life expectancy ≥4months
• Eastern Cooperative Oncology Group performance status 0 to 2
  • Phase 2 (A), Phase 3 (B) \& (C) Exclusion Criteria (EC):
• Anorexia or cachexia caused by reasons other than cancer (for example, severe chronic obstructive pulmonary disease \[COPD\] with home oxygen support)
• Reversible causes of reduced food intake, as determined by the Investigator.
• Dysphagia, calorie-restricted diet within 6 months prior to first dose, or poor food digestion and absorption
• Currently receiving tube feedings or parenteral nutrition (either total or partial)
• Have received medications and/or herbal supplements to enhance appetite and/or intended to treat unintentional weight loss
• Patients with uncontrolled or significant cardiovascular disease
• Clinically significant recurrent ascites, pleural effusion, pericardial effusion and or significant edema
• Creatinine clearance ≤30 mL/min (measured or calculated by Cockcroft and Gault equation)
• Aspartate aminotransferase or alanine aminotransferase \>5 × the upper limit of normal (ULN) OR total bilirubin \>2 × ULN
• Alkaline phosphatase (ALP) \>3 x ULN (ALP \>5× ULN if there is liver involvement by the tumor and/or in case of bone metastases)
  • OLE (D) IC:
• The patient completed double-blind treatment period
• The patient expressed interest in participating in the optional OLE sub-study and provided a signed informed consent form specific to the OLE.
• In the opinion of the Investigator, the patient continues to derive clinical benefit from study treatment, has not experienced any intolerable treatment-related toxicity of National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 6.0 Grade ≥ 2
  • OLE (D) EC:
• None