A Phase I Clinical Study to Evaluate the Efficacy and Safety of GB18 Injection in Patients With Tumor Cachexia

NCT07519564 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: KXZY-GB18-101(1B)
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 2

Brief Summary

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).

Conditions

Cachexia; Cancer

Keywords

Cachexia; Cancer; GB18; First-in-patient

Outcome Measures

Primary Outcomes (1)

• 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.

  From pre-dosing to the end of follow-up at 24 weeks

Secondary Outcomes (11)

• Change of the third lumbar vertebra skeletal muscle index (LSMI) from the baseline

  From pre-dosing to 18 weeks after the first dosage of GB18

• Change of body weight compared to baseline

  From pre-dosing to the end of follow-up at 24 weeks

• Changes from baseline in Functional Assessment of Anorexia/Cachexia Therapy (FAACT) score and its subscales

  From pre-dosing to 18 weeks after the first dosage of GB18

• Changes in physical activity and sleep compared to the baseline

  From pre-dosing to end of treatment at 12 weeks

• Change from baseline in Patient-Reported Outcomes Measurement Information System (PROMIS)-Physiological Function Score

  From pre-dosing to 18 weeks after the first dosage of GB18

Study Arms (3)

GB18 B1

EXPERIMENTAL

GB18 B1 s.c.

Drug: GB18

GB18 B2

EXPERIMENTAL

GB18 B2 s.c.

Drug: GB18

GB18 B3

EXPERIMENTAL

GB18 B3 s.c.

Drug: GB18

Interventions

GB18 DRUG

GB18 will be administered via subcutaneous injection with different doses.

GB18 B1; GB18 B2; GB18 B3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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 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.
• 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.

You may not qualify 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 nausea, vomiting, diarrhea, or constipation; mechanical obstruction preventing oral intake.
• 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 atrioventricular block, arrhythmias (including sustained ventricular tachycardia or ventricular fibrillation), unstable angina, acute coronary syndrome, symptomatic congestive heart failure (NYHA class III or IV) of coronary or peripheral origin, stroke, transient ischemic attack, or symptomatic pulmonary embolism or other clinically significant thromboembolic disease.
• 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 during the study period.
• 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 investigational drug.
• Severe infection requiring intravenous antibiotics, antivirals, or antifungal agents within 14 days before the first dose of the investigational drug.

Sponsors & Collaborators

• Kexing Biopharm Co., Ltd.: lead

Study Sites (2)

Peking University Cancer Hospital

Beijing, Beijing Municipality, 100142, China

RECRUITING

Beijing GoBroad Hospital

Beijing, Beijing Municipality, 102200, China

RECRUITING

MeSH Terms

Conditions

Cachexia; Neoplasms

Interventions

alkaloid GB18

Condition Hierarchy (Ancestors)

Weight Loss; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Thinness

Central Study Contacts

Jinhai Lin

CONTACT

400-888-9496; linjinhai@kexing.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2026
• First Posted: April 9, 2026
• Study Start: June 10, 2026
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): December 30, 2027
• Last Updated: June 12, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)