KXZY-GB18-101(1B) is an extension of KXZY-GB18-101, a first-in-human, dose-escalation trial in healthy adult participants to evaluate the safety, tolerability, PK, PD, and immunogenicity of GB18.
As a humanized GDF15 monoclonal antibody, GB18 is expected to improve anorexia and weight loss caused by metabolic disorders driven by overactivation of the GDF15-GFRAL-RET signaling pathways. With favorable readouts of KXZY-GB18-101, this study aims to evaluate the effects of GB18 in patients with tumor cachexia. This open-label, multiple-ascending-dosing study will enroll 18-36 participants into 3 dosing-level cohorts (B1-B3, each with 6-12 participants).
Voluntarily serve as a participant and sign the informed consent form;
Age ≥ 18 years;
Histologically or cytologically confirmed, non-resectable, locally advanced, recurrent, or metastatic solid tumors with failed standard treatment or have no standard treatment options. This includes, but is not limited to, colorectal cancer, pancreatic cancer, gastric cancer, esophageal cancer, biliary tract cancer, non-small cell lung cancer, prostate cancer, breast cancer, or ovarian cancer.
Diagnosed with cancer cachexia: BMI < 18.5 kg/m², and no unintentional weight loss > 2% within 6 months before screening, or no unintentional weight loss > 5% within 6 months before screening regardless of BMI.
Known active/symptomatic central nervous system metastases and/or carcinomatous meningitis.
Plan to receive radiotherapy as a component of the primary antitumor treatment regimen.
BMI > 26 kg/m².
Presence of reversible causes for reduced food intake, including but not limited to NCI CTCAE grade 3 or 4 oral mucositis; NCI CTCAE grade 3 or 4 nausea, vomiting, diarrhea, or constipation; mechanical obstruction preventing oral intake.
Sequential
GB18
DrugGB18 will be administered via subcutaneous injection with different doses.
Incidence of adverse events
The number and severity of adverse events (e.g., abnormalities in laboratory tests, vital signs, physical examinations, and 12-lead ECGs, as assessed by CTCAE v6.0) will be recorded and analyzed.
Change of the third lumbar vertebra skeletal muscle index (LSMI) from the baseline
The change of the third lumbar vertebra skeletal muscle index (LSMI) from the baseline evaluated by computed tomography scan
Change of body weight compared to baseline
The change of body weight compared to baseline
Changes from baseline in Functional Assessment of Anorexia/Cachexia Therapy (FAACT) score and its subscales
The changes from baseline in the total score of the Functional Assessment of Anorexia/Cachexia Therapy (FAACT) and its subscales
Changes in physical activity and sleep compared to the baseline
Changes in physical activity and sleep will be evaluated by acceleration measurement method via wearable devices
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