Cachexia; CancerPhase 1NCT07519564
A Phase I Clinical Study to Evaluate the Efficacy and Safety of GB18 Injection in Patients With Tumor Cachexia
A Phase 1 study testing GB18 in people with Cachexia; Cancer, run by Kexing Biopharm Co., Ltd. at 2 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cachexia; Cancer
- What is being tested?
- GB18
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 2 sitesChina
- Study dates
- 10 Jun 2026to 30 Dec 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
Peking University Cancer Hospital
Beijing, Beijing Municipality, 100142
Lin Shen, 010-50847588-889, doctorshenlin@sina.com
Lin Shen
- Recruiting
Beijing GoBroad Hospital
Beijing, Beijing Municipality, 102200
Ming Lu, 010-50847588-889, lum6@gobroadhealthcare.com
Ming Lu
About this study
Official title: A Phase I Clinical Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Efficacy, and Safety of GB18 Injection in Patients With Tumor Cachexia
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).
Read the detailed description
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 associated with metabolic disorders by targeting the overactivation of GDF15-GFRAL-RET signaling pathways. With favorable readouts of KXZY-GB18-101, KXZY-GB18-101(1B) aims to evaluate the efficacy and safety of GB18 in patients with tumor cachexia. This open-label, multiple-ascending-dosing study will enroll 18-36 participants into 3 dosing-level cohorts (each with 6-12 participants). The treatment and follow-up period will be 12 weeks each. Each participant will undergo safety and efficacy assessments, including vital sign measurements, physical examinations, 12-lead electrocardiograms, and laboratory tests before and after GB18 administration. Blood samples will also be collected to evaluate pharmacokinetic and pharmacodynamic properties, as well as the immunogenicity.
The aims of this study include:
- To evaluate the safety and tolerability of GB18 after multiple subcutaneous injections of GB18 in Chinese participants with tumor cachexia.
- To evaluate the efficacy of multiple subcutaneous injections of GB18 in Chinese participants with tumor cachexia.
- To evaluate the PK characteristics of Chinese tumor cachexia participants after multiple subcutaneous injections of GB18.
- To evaluate the PD characteristics of Chinese participants with tumor cachexia after multiple subcutaneous injections of GB18.
- To evaluate the immunogenicity of multiple subcutaneous injections of GB18 in Chinese participants with tumor cachexia.
- Conditions
- Cachexia; Cancer
- Being tested
- GB18
- Keywords
- Cachexia, Cancer, GB18, First-in-patient
- Medical subject headings
- Cachexia, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GB18Drug
GB18 will be administered via subcutaneous injection with different doses.
| Study group | Role | What they receive |
|---|---|---|
| GB18 B1 | Experimental | GB18 B1 s.c. Receives: Drug: GB18 |
| GB18 B2 | Experimental | GB18 B2 s.c. Receives: Drug: GB18 |
| GB18 B3 | Experimental | GB18 B3 s.c. Receives: Drug: GB18 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
The change of the third lumbar vertebra skeletal muscle index (LSMI) from the baseline evaluated by computed tomography scan
Measured: From pre-dosing to 18 weeks after the first dosage of GB18
Change of body weight compared to baseline
The change of body weight compared to baseline
Measured: 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
The changes from baseline in the total score of the Functional Assessment of Anorexia/Cachexia Therapy (FAACT) and its subscales
Measured: From pre-dosing to 18 weeks after the first dosage of GB18
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
Measured: From pre-dosing to end of treatment at 12 weeks
Change from baseline in Patient-Reported Outcomes Measurement Information System (PROMIS)-Physiological Function Score
Change from baseline in Patient-Reported Outcomes Measurement Information System (PROMIS)-Physiological Function Score
Measured: From pre-dosing to 18 weeks after the first dosage of GB18
Change from baseline in PROMIS-fatigue score
Change from baseline in PROMIS-fatigue score
Measured: From pre-dosing to 18 weeks after the first dosage of GB18
Tmax of GB18 concentration
Tmax of GB18 concentration
Measured: From pre-dosing to end of follow-up at 24 weeks
Cmax of GB18
Cmax of GB18
Measured: From pre-dosing to end of follow-up at 24 weeks
AUC0-t of GB18
AUC0-t of GB18
Measured: From pre-dosing to end of follow-up at 24 weeks
Serum concentrations of total and unbound (if feasible) GDF15
Serum concentrations of total and, if feasible, unbound GDF15 specified in the schedule of activities.
Measured: From pre-dosing to end of follow-up at 24 weeks
(if applicable) Incidence of ADA and Nab
(if applicable) Incidence of ADA and Nab
Measured: From pre-dosing to end of follow-up at 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2026
- Study start10 Jun 2026
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cachexia; CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kexing Biopharm Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07519564
- Sponsor's protocol ID
- KXZY-GB18-101(1B)
- Status last verified
- Dec 2025
- First submitted
- 2 Apr 2026
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Clinical Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Efficacy, and Safety of GB18 Injection in Patients With Tumor Cachexia
- ClinicalTrials.gov ID
- NCT07519564
- Acronym / sponsor ID
- KXZY-GB18-101(1B)
- Conditions
- Cachexia; Cancer
- Keywords
- Cachexia, Cancer, GB18, First-in-patient
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Kexing Biopharm Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 10 Jun 2026 (actual)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 9 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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 associated with metabolic disorders by targeting the overactivation of GDF15-GFRAL-RET signaling pathways. With favorable readouts of KXZY-GB18-101, KXZY-GB18-101(1B) aims to evaluate the efficacy and safety of GB18 in patients with tumor cachexia. This open-label, multiple-ascending-dosing study will enroll 18-36 participants into 3 dosing-level cohorts (each with 6-12 participants). The treatment and follow-up period will be 12 weeks each. Each participant will undergo safety and efficacy assessments, including vital sign measurements, physical examinations, 12-lead electrocardiograms, and laboratory tests before and after GB18 administration. Blood samples will also be collected to evaluate pharmacokinetic and pharmacodynamic properties, as well as the immunogenicity.
The aims of this study include:
- To evaluate the safety and tolerability of GB18 after multiple subcutaneous injections of GB18 in Chinese participants with tumor cachexia.
- To evaluate the efficacy of multiple subcutaneous injections of GB18 in Chinese participants with tumor cachexia.
- To evaluate the PK characteristics of Chinese tumor cachexia participants after multiple subcutaneous injections of GB18.
- To evaluate the PD characteristics of Chinese participants with tumor cachexia after multiple subcutaneous injections of GB18.
- To evaluate the immunogenicity of multiple subcutaneous injections of GB18 in Chinese participants with tumor cachexia.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| GB18 B1 | Experimental | Drug: GB18GB18 B1 s.c. |
| GB18 B2 | Experimental | Drug: GB18GB18 B2 s.c. |
| GB18 B3 | Experimental | Drug: GB18GB18 B3 s.c. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GB18GB18 will be administered via subcutaneous injection with different doses. | Drug | GB18 B1, GB18 B2, GB18 B3 |
Primary outcome
Incidence of adverse events
Time frame: From pre-dosing to the end of follow-up at 24 weeks
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.
11 secondary outcomes
Change of the third lumbar vertebra skeletal muscle index (LSMI) from the baseline
Time frame: From pre-dosing to 18 weeks after the first dosage of GB18
Change of body weight compared to baseline
Time frame: 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
Time frame: From pre-dosing to 18 weeks after the first dosage of GB18
Changes in physical activity and sleep compared to the baseline
Time frame: From pre-dosing to end of treatment at 12 weeks
Change from baseline in Patient-Reported Outcomes Measurement Information System (PROMIS)-Physiological Function Score
Time frame: From pre-dosing to 18 weeks after the first dosage of GB18
Change from baseline in PROMIS-fatigue score
Time frame: From pre-dosing to 18 weeks after the first dosage of GB18
Tmax of GB18 concentration
Time frame: From pre-dosing to end of follow-up at 24 weeks
Cmax of GB18
Time frame: From pre-dosing to end of follow-up at 24 weeks
AUC0-t of GB18
Time frame: From pre-dosing to end of follow-up at 24 weeks
Serum concentrations of total and unbound (if feasible) GDF15
Time frame: From pre-dosing to end of follow-up at 24 weeks
(if applicable) Incidence of ADA and Nab
Time frame: From pre-dosing to end of follow-up at 24 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GB18 in people with Cachexia; Cancer, run by Kexing Biopharm Co., Ltd. at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jinhai Lin (400-888-9496, linjinhai@kexing.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse events (time frame: From pre-dosing to the end of follow-up at 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2026.