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;
Single group
INB301 Injection
Biological/VaccineThe screening will be completed within 28 days before administration. Subjects who pass the screening will receive subcutaneous injection of INB301 until the investigator determines that the risk of continued treatment outweighs the benefit, toxicity becomes intolerable, or other criteria for withdrawal or treatment discontinuation are met, whichever occurs first. The end-of-study/early withdrawal visit will be completed at 28 days (±7 days) after the last dose. Each 1 mL of INB301 Injection contains 100 mg of the drug, and 2 mL of the drug can be injected at each subcutaneous injection site, which is at the left and right abdominal subcutaneous tissue, as well as the left and right arm subcutaneous tissue. The specific dose is determined according to the dose cohort. Dosing every 3 or 4 weeks is proposed.
Adverse Events
Mean change in body weight from baseline during each assessment period within 12 weeks.
Area under the plasma concentration-time curve (AUC)
Half-life (t1/2)
Peak concentration (Cmax)
Time to peak concentration (Tmax)
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