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Tests treatment safety and results for Cachexia; Cancer
Official title A Phase I Clinical Study to Evaluate the Efficacy and Safety of GB18 Injection in Patients With Tumor Cachexia
ClinicalTrials.gov ID: NCT07519564
What this study is testing
What is GB18?
GB18 is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for cachexia; cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Diagnosed with cancer cachexia: BMI \ 2% within 6 months before screening, or no unintentional weight loss \> 5% within 6 months before screening...
- A serum GDF15 concentration ≥ 1.5 ng/mL.
You likely can't join if
- 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...
- Comorbid conditions unrelated to tumor cachexia that cause difficulty in eating or malabsorption.
- Cachexia due to other investigator-determined or clearly defined causes. History within the past 6 months of any of the following: myocardial...
See the full eligibility criteria
- 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...
- Diagnosed with cancer cachexia: BMI \ 2% within 6 months before screening, or no unintentional weight loss \> 5% within 6 months before screening regardless of BMI.
- A serum GDF15 concentration ≥ 1.5 ng/mL.
- Laboratory Test Requirements:
- Absolute neutrophil count ≥ 1.0 × 10⁹/L, platelet count ≥ 75 × 10⁹/L, hemoglobin ≥ 80 g/L.
- Serum creatinine ≤ 1.5 × ULN (Upper Limit of Normal).
- Total bilirubin ≤ 1.5 × ULN, AST and ALT ≤ 3 × ULN (or ≤ 5 × ULN for patients with liver metastasis).
- Activated partial thromboplastin time ≤ 1.5 × ULN, International Normalized Ratio ≤ 1.5.
- Left Ventricular Ejection Fraction \> 50% as assessed by echocardiogram.
- Eastern Cooperative Oncology Group (ECOG) performance status score: 0-2 points
- Expected survival period ≥ 4 months. Key
- 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...
- Comorbid conditions unrelated to tumor cachexia that cause difficulty in eating or malabsorption.
- Cachexia due to other investigator-determined or clearly defined causes. History within the past 6 months of any of the following: myocardial infarction, congenital long QT syndrome, second- or third-degree...
- Hypertension with unsatisfactory control despite antihypertensive therapy (defined as systolic blood pressure \> 150 mmHg or diastolic blood pressure \> 90 mmHg).
- Patients receiving tube feeding or parenteral nutrition (total or partial) within 28 days before the first administration of the investigational drug.
- Initiation of new systemic glucocorticoid therapy from 28 days before the first dose of the investigational drug to the end of the study.
- Major surgery not yet recovered from within 28 days before the first dose of the investigational drug (central venous access placement and tumor biopsy are not considered major surgery), or anticipated major surgery...
- Prior participation in clinical trials targeting the GDF-15/GFRAL signaling pathways, or receipt of other investigational agents within 28 days or five half-lives (whichever is shorter) before the first dose of the...
- Severe infection requiring intravenous antibiotics, antivirals, or antifungal agents within 14 days before the first dose of the investigational drug.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.