This is an open-label, multicenter, multiple-dose Phase I/IIa clinical study to assess the safety/tolerability, PK characteristics,immunogenicity, and preliminary efficacy of INB301 Injection in patients with cancer cachexia.
The indication to be explored for Phase I is malignant solid tumor with cachexia; Phase IIa will determine the specific study cohort after discussion between the investigator and the sponsor based on the previously obtained clinical trial data and the benefit/risk ratio of the subjects, and preliminarily consider 3 cohorts of tentative 20-30 patients each, including non-small cell lung cancer, pancreatic cancer and colorectal cancer with cachexia.
Subjects who voluntarily participate in the study and voluntarily sign the informed consent form;
Male or female ≥ 18 years of age;
Subjects with histologically or cytologically confirmed malignant solid tumors (including pathologically confirmed non-small cell lung cancer, colorectal cancer, pancreatic cancer, esophageal cancer or breast cancer, etc.) who are receiving or have completed anti-cancer treatment and have no significant cancer progression 28 days before the first dose, and in the investigator's expectation are unlikely to change the anti-cancer regimen due to disease progression or do not require any anti-cancer treatment within the first cycle (21 days) of the study;
Definitely diagnosed as cancer cachexia according to the 2025 Definition and Classification of Cancer Cachexia: An International Consensus" combined with clinical practice: one of the following occurs within 6 months (recognized documentation is required for past weight data): involuntary weight loss > 5%, or weight loss > 2% when BMI < 18.5 kg/m² ;
Other causes that may lead to reduced food intake or seriously affect digestion and absorption during the screening period, as determined by the investigator, including but not limited to: oral mucositis of NCI CTCAE Grade 3 or above, gastrointestinal disease of NCI CTCAE Grade 3 or above (nausea, vomiting, diarrhea and constipation, etc.), gastrointestinal obstruction, and active inflammatory bowel disease;
Radiotherapy is planned as part of the primary anti-cancer treatment regimen (except local radiotherapy for symptom relief);
Known active/symptomatic central nervous system (CNS) metastases and/or carcinomatous meningitis (for subjects with previously treated brain metastases, enrollment may be considered if all of the following criteria are met: the clinical condition has remained stable with no imaging evidence of disease progression within 4 weeks before the first investigational drug treatment, and corticosteroid treatment has not been required within 4 weeks before first dose; asymptomatic subjects with brain metastases (i.e., no neurologic symptoms, no requirement for corticosteroids, and no brain metastatic lesion with a longest diameter > 1.5 cm) may be enrolled, provided that regular imaging examination and assessment for brain metastatic lesions are performed);
Gavage or parenteral nutrition (total or partial) is received during the screening period;