Cancer Cachexia (CC)Phase 1NCT07237464
To Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of GB18 Injection in Healthy Participants
A Phase 1 study testing GB18 injection in people with Cancer Cachexia (CC) and Cancer Cachexia, run by Shenzhen Kexing Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
This study is a first-in-human, randomized, double-blind, placebo-controlled, 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 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Cancer Cachexia (CC), Cancer Cachexia, Cancer Cachexia Syndrome
- What is being tested?
- GB18 injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteChina
- Study dates
- 28 Oct 2025to 20 Apr 2026
- 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 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participants who have signed the informed consent form (ICF) prior to the study, fully understand the content, procedures, and possible adverse reactions of the study, and are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
- Male and female participants aged 18-55 years (inclusive), at the time of signing the ICF.
- Body weight ≥ 50 kg for males and ≥ 45 kg for females, with a body mass index (BMI = weight (kg)/height 2 (m) 2) of 18.5-26 kg/m2 (inclusive).
- Male and female participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, Vital signs, 12-lead ECG, and laboratory tests.
- Participants (including their partners) who have no plan to become pregnant and voluntarily use effective contraception from screening to 6 months after the last dose.
Who cannot join
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
- History of HIV infection, syphilis, hepatitis B, or hepatitis C; positive testing for HIV, syphilis, HBsAg, or HCVAb.
- History of allergic or anaphylactic reaction to any therapeutic or diagnostic monoclonal antibody or molecules made of components of monoclonal antibodies.
- History of recurrent infections or active infections.
- Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior, or other conditions that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
- Smoking more than five cigarettes per day on average, or habitually used nicotine containing products, or unable to refrain from smoking during the trial.
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- Use of prescription or nonprescription drugs and dietary and herbal supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study intervention.
- Exposure to live vaccines within 28 days of screening.
- Previous administration with an investigational drug within 30 days or marketed or investigational monoclonal antibodies within 3 months or 5 half-lives preceding the first dose of study intervention used in this study (whichever is longer).
- History of drug abuse within the past 5 years or use of drugs in the 3 months prior to screening, or a positive urine drug test at screening.
- Screening BP ≥140 mm Hg (systolic) or ≥90 mm Hg (diastolic), following at least 5 minutes of rest. If BP is ≥140 mm Hg (systolic) or ≥90 mm Hg (diastolic), the BP should be repeated 2 more times and the average of the 3 BP values should be used to determine the participant's eligibility.
- Screening 12-lead ECG that demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of study results (eg, baseline QTcF interval >450 msec, or QRS interval >120 msec). If QTcF exceeds 450 msec, or QRS exceeds 120 msec, the ECG should be repeated 2 more times and the average of the 3 QTcF or QRS values should be used to determine the participant's eligibility.
- Participants with ANY of the following abnormalities in clinical laboratory tests at screening, as assessed by the study-specific laboratory and confirmed by a single repeat test, if deemed necessary:
- AST or ALT level ≥1.5 × ULN,
- Total bilirubin level ≥1.5 × ULN; participants with a history of Gilbert's syndrome may have direct bilirubin measured and would be eligible for this study provided the direct bilirubin level is ≤ ULN.
- History of alcohol abuse or binge drinking and/or any other illicit drug use or dependence within 3 months of Screening. As a general rule, alcohol intake should not exceed 14 units per week (1 unit = 360 mL beer, 45 mL of 40% spirit or 150 mL of wine).
- Blood donation (excluding plasma donations) of approximately 400 mL or more within 60 days prior to dosing.
- Participants who, in the judgment of the investigator, are not suitable for participation in the study.
- Skin scar, rash, or ulceration at the injection site (abdomen).
- History of vasovagal syncope or needle phobia, and inability to tolerate venous indwelling catheter blood collection.
- Participants who plan to donate sperm or oocytes within 6 months after administration of the investigational drug.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Beijing GoBroad Hospital
Beijing, Beijing Municipality
Qing He, 010-50847588-889, heq@gobroadhealthcare.com
Qing He
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Phase I Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of GB18 Following Single Subcutaneous Injection in Healthy Adult Participants
This study is a first-in-human, randomized, double-blind, placebo-controlled, dose-escalation trial in healthy adult participants to evaluate the safety, tolerability, PK, PD, and immunogenicity of GB18.
A total of 36 healthy participants will be enrolled, including 5 dose cohorts (A1-A5) of 50 mg, 100 mg, 200 mg, 400 mg and 600 mg, with 4 participants in Cohort A1, and 8 participants per following cohorts (A2-A5). Participants in each cohort will be randomized to receive GB18 or placebo.
Read more
The arms of this study include:
To evaluate the safety and tolerability of GB18 following a single subcutaneous (SC) administered dose in healthy adult participants.
To characterize the serum pharmacokinetics (PK) of GB18 following a single SC administered dose in healthy adult participants.
To characterize the pharmacodynamics (PD) of a single SC administration of GB18 on circulating GDF15 concentrations in healthy adult participants.
To evaluate the immunogenicity profile of GB18 in healthy adult participants. To evaluate the effect of GB18 on body weight in healthy adult participants. To preliminary evaluation of the relationship between GB18 serum concentration and QTc interval after a single SC administration in healthy adult participants.
Read the detailed description
This study is a first-in-human, randomized, double-blind, placebo-controlled, dose-escalation trial in healthy adult participants to evaluate the safety, tolerability, PK, PD, and immunogenicity of GB18.
A total of 36 healthy participants will be enrolled, including 5 dose cohorts (A1-A5) of 50 mg, 100 mg, 200 mg, 400 mg and 600 mg, with 4 participants in Cohort A1, and 8 participants per following cohorts (A2-A5). Participants in each cohort will be randomized to receive GB18 or placebo at a ratio of 3:1, with 3 participants receiving GB18 and 1 participant receiving placebo in Cohort A1, and 6 participants receiving GB18 and 2 participants receiving placebo in the remaining cohorts (A2-A5).
Healthy participants will be screened within 28 days prior to dosing. Participants will be admitted to the Clinical Research Unit (CRU) on Day -1 and receive a single subcutaneous dose of GB18 or placebo on Day 1 at the abdomen. Participants will receive safety assessments on Day 8 and can be discharged with the permission of the investigator. Safety assessments and PK/PD/immunogenicity sampling will be carried out at scheduled timepoints.
The participants will return to the CRU on Day 10, 15, 29, 50, 71, 92, 106 and 127 for blood sampling, safety, and other assessments such as vital signs, ECG, and laboratory test etc.
GB18 will be administered to participants at a starting dose of 50 mg and increasing to 100, 200, 400 and 600 mg in sequential dosing cohorts. The Safety Review Committee (SRC) will assess the safety data, PK data and available PD data at least up to Day 15 (Cohort A1-2)/29 (Cohort A3-5) after the dose administration of each cohort, and a decision of whether to escalate to the next higher dose level or adjust the dose or discontinue dosing will be made by the SRC.
For the safety of participants, 2 sentinel participants will be randomly dosed (GB18: placebo=1:1) at least 24 hours before the remaining participants in the cohort receive dosing, except for Cohort A1. Once safety is confirmed, the remaining participants will be dosed.
- Being tested
- GB18 injection, Placebo
- Keywords
- Cancer cachexia, GB18, healthy adult, Phase I, pharmacokinetics, pharmacodynamics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GB18 injectionDrug
GB18 will be administered to participants at a starting dose of 50 mg and increasing to 100, 200, 400 and 600 mg in sequential dosing cohorts.
PlaceboDrug
Placebo will be administered to participants at doses matching GB18.
| Study group | Role | What they receive |
|---|---|---|
| A1-50mg-GB18 | Experimental | Not described Receives: Drug: GB18 injection |
| A1-50mg-placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| A2-100mg-GB18 | Experimental | Not described Receives: Drug: GB18 injection |
| A2-100mg-placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| A3-200mg-GB18 | Experimental | Not described Receives: Drug: GB18 injection |
| A3-200mg-placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| A4-400mg-GB18 | Experimental | Not described Receives: Drug: GB18 injection |
| A4-400mg-placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| A5-600mg-GB18 | Experimental | Not described Receives: Drug: GB18 injection |
| A5-600mg-placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of adverse events as assessed by CTCAE v5.0
The number of AEs (e.g., abnormalities in laboratory tests, vital signs, physical examinations, and 12-lead ECGs) will be recorded and analyzed.
Measured: From pre-dosing to the end of follow-up at 18 weeks
Secondary outcomes (3)
Serum pharmacokinetics parameters (Cmax, Tmax, AUC0-inf, AUC0-t, λz, t1/2, Vz/F, and CL/F).
GB18 Serum pharmacokinetics parameters (unbound and total), including but not limited to maximum concentration (Cmax), peak time (Tmax), area under the serum concentration-time curve from time 0 to infinity (AUC0-inf), area under the serum concentration-time curve from time 0 (pre-dose) to the time t (AUC0-t), elimination rate constant (λz), elimination half-life (t1/2), apparent volume of distribution (Vz/F), apparent total serum clearance (CL/F).
Measured: From pre-dosing to the end of follow-up at 18 weeks
Serum concentrations of total and, if feasible, unbound GDF15 specified in the schedule of activities.
Measured: From pre-dosing to the end of follow-up at 18 weeks
(if applicable) Incidence of ADA and Nab
Measured: From pre-dosing to the end of follow-up at 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2025
- Study start28 Oct 2025
- Primary completion20 Jan 2026 (estimated)
- Study completion20 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Cancer Cachexia (CC)Studies 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
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shenzhen Kexing Pharmaceutical Co., Ltd.
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07237464
- Sponsor's protocol ID
- KXZY-GB18-101
- Status last verified
- Sep 2025
- First submitted
- 26 Sep 2025
- Last updated
- 19 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Joo M, Kim D, Lee MW, Lee HJ, Kim JM. GDF15 Promotes Cell Growth, Migration, and Invasion in Gastric Cancer by Inducing STAT3 Activation. Int J Mol Sci. 2023 Feb 2;24(3):2925. doi: 10.3390/ijms24032925.
PubMed 36769245Tsui KH, Hsu SY, Chung LC, Lin YH, Feng TH, Lee TY, Chang PL, Juang HH. Growth differentiation factor-15: a p53- and demethylation-upregulating gene represses cell proliferation, invasion, and tumorigenesis in bladder carcinoma cells. Sci Rep. 2015 Aug 7;5:12870. doi: 10.1038/srep12870.
PubMed 26249737Lerner L, Hayes TG, Tao N, Krieger B, Feng B, Wu Z, Nicoletti R, Chiu MI, Gyuris J, Garcia JM. Plasma growth differentiation factor 15 is associated with weight loss and mortality in cancer patients. J Cachexia Sarcopenia Muscle. 2015 Dec;6(4):317-24. doi: 10.1002/jcsm.12033. Epub 2015 Apr 30.
PubMed 26672741Suzuki H, Mitsunaga S, Ikeda M, Aoyama T, Yoshizawa K, Yoshimatsu H, Kawai N, Masuda M, Miura T, Ochiai A. Clinical and Tumor Characteristics of Patients with High Serum Levels of Growth Differentiation Factor 15 in Advanced Pancreatic Cancer. Cancers (Basel). 2021 Sep 28;13(19):4842. doi: 10.3390/cancers13194842.
PubMed 34638326Niu Y, Zhang W, Shi J, Liu Y, Zhang H, Lin N, Li X, Qin L, Yang Z, Su Q. The Relationship Between Circulating Growth Differentiation Factor 15 Levels and Diabetic Retinopathy in Patients With Type 2 Diabetes. Front Endocrinol (Lausanne). 2021 Mar 15;12:627395. doi: 10.3389/fendo.2021.627395. eCollection 2021.
PubMed 33790859Siddiqui JA, Pothuraju R, Khan P, Sharma G, Muniyan S, Seshacharyulu P, Jain M, Nasser MW, Batra SK. Pathophysiological role of growth differentiation factor 15 (GDF15) in obesity, cancer, and cachexia. Cytokine Growth Factor Rev. 2022 Apr;64:71-83. doi: 10.1016/j.cytogfr.2021.11.002. Epub 2021 Nov 17.
PubMed 34836750Tsai VW, Brown DA, Breit SN. Targeting the divergent TGFbeta superfamily cytokine MIC-1/GDF15 for therapy of anorexia/cachexia syndromes. Curr Opin Support Palliat Care. 2018 Dec;12(4):404-409. doi: 10.1097/SPC.0000000000000384.
PubMed 30382947Wischhusen J, Melero I, Fridman WH. Growth/Differentiation Factor-15 (GDF-15): From Biomarker to Novel Targetable Immune Checkpoint. Front Immunol. 2020 May 19;11:951. doi: 10.3389/fimmu.2020.00951. eCollection 2020.
PubMed 32508832Grande AJ, Silva V, Sawaris Neto L, Teixeira Basmage JP, Peccin MS, Maddocks M. Exercise for cancer cachexia in adults. Cochrane Database Syst Rev. 2021 Mar 18;3(3):CD010804. doi: 10.1002/14651858.CD010804.pub3.
PubMed 33735441Balstad TR, Brunelli C, Pettersen CH, Schonberg SA, Skorpen F, Fallon M, Kaasa S, Bye A, Laird BJA, Stene GB, Solheim TS. Power Comparisons and Clinical Meaning of Outcome Measures in Assessing Treatment Effect in Cancer Cachexia: Secondary Analysis From a Randomized Pilot Multimodal Intervention Trial. Front Nutr. 2021 Jan 14;7:602775. doi: 10.3389/fnut.2020.602775. eCollection 2020.
PubMed 33585533Argiles JM, Stemmler B, Lopez-Soriano FJ, Busquets S. Inter-tissue communication in cancer cachexia. Nat Rev Endocrinol. 2018 Dec;15(1):9-20. doi: 10.1038/s41574-018-0123-0.
PubMed 30464312Ferrer M, Anthony TG, Ayres JS, Biffi G, Brown JC, Caan BJ, Cespedes Feliciano EM, Coll AP, Dunne RF, Goncalves MD, Grethlein J, Heymsfield SB, Hui S, Jamal-Hanjani M, Lam JM, Lewis DY, McCandlish D, Mustian KM, O'Rahilly S, Perrimon N, White EP, Janowitz T. Cachexia: A systemic consequence of progressive, unresolved disease. Cell. 2023 Apr 27;186(9):1824-1845. doi: 10.1016/j.cell.2023.03.028.
PubMed 37116469Yu J, Choi S, Park A, Do J, Nam D, Kim Y, Noh J, Lee KY, Maeng CH, Park KS. Bone Marrow Homeostasis Is Impaired via JAK/STAT and Glucocorticoid Signaling in Cancer Cachexia Model. Cancers (Basel). 2021 Mar 2;13(5):1059. doi: 10.3390/cancers13051059.
PubMed 33801569Naito T. Evaluation of the True Endpoint of Clinical Trials for Cancer Cachexia. Asia Pac J Oncol Nurs. 2019 Jul-Sep;6(3):227-233. doi: 10.4103/apjon.apjon_68_18.
PubMed 31259217Nishikawa H, Goto M, Fukunishi S, Asai A, Nishiguchi S, Higuchi K. Cancer Cachexia: Its Mechanism and Clinical Significance. Int J Mol Sci. 2021 Aug 6;22(16):8491. doi: 10.3390/ijms22168491.
PubMed 34445197
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Phase I Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of GB18 Following Single Subcutaneous Injection in Healthy Adult Participants
- ClinicalTrials.gov ID
- NCT07237464
- Acronym / sponsor ID
- KXZY-GB18-101
- Keywords
- Cancer cachexia, GB18, healthy adult, Phase I, pharmacokinetics, pharmacodynamics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Shenzhen Kexing Pharmaceutical Co., Ltd.Research network
- Study start
- 28 Oct 2025 (actual)
- Primary completion
- 20 Jan 2026 (estimated)
- Study completion
- 20 Apr 2026 (estimated)
- First posted
- 19 Nov 2025 (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.
This study is a first-in-human, randomized, double-blind, placebo-controlled, dose-escalation trial in healthy adult participants to evaluate the safety, tolerability, PK, PD, and immunogenicity of GB18.
A total of 36 healthy participants will be enrolled, including 5 dose cohorts (A1-A5) of 50 mg, 100 mg, 200 mg, 400 mg and 600 mg, with 4 participants in Cohort A1, and 8 participants per following cohorts (A2-A5). Participants in each cohort will be randomized to receive GB18 or placebo.
The arms of this study include:
To evaluate the safety and tolerability of GB18 following a single subcutaneous (SC) administered dose in healthy adult participants.
To characterize the serum pharmacokinetics (PK) of GB18 following a single SC administered dose in healthy adult participants.
To characterize the pharmacodynamics (PD) of a single SC administration of GB18 on circulating GDF15 concentrations in healthy adult participants.
To evaluate the immunogenicity profile of GB18 in healthy adult participants. To evaluate the effect of GB18 on body weight in healthy adult participants. To preliminary evaluation of the relationship between GB18 serum concentration and QTc interval after a single SC administration in healthy adult participants.
Detailed description
This study is a first-in-human, randomized, double-blind, placebo-controlled, dose-escalation trial in healthy adult participants to evaluate the safety, tolerability, PK, PD, and immunogenicity of GB18.
A total of 36 healthy participants will be enrolled, including 5 dose cohorts (A1-A5) of 50 mg, 100 mg, 200 mg, 400 mg and 600 mg, with 4 participants in Cohort A1, and 8 participants per following cohorts (A2-A5). Participants in each cohort will be randomized to receive GB18 or placebo at a ratio of 3:1, with 3 participants receiving GB18 and 1 participant receiving placebo in Cohort A1, and 6 participants receiving GB18 and 2 participants receiving placebo in the remaining cohorts (A2-A5).
Healthy participants will be screened within 28 days prior to dosing. Participants will be admitted to the Clinical Research Unit (CRU) on Day -1 and receive a single subcutaneous dose of GB18 or placebo on Day 1 at the abdomen. Participants will receive safety assessments on Day 8 and can be discharged with the permission of the investigator. Safety assessments and PK/PD/immunogenicity sampling will be carried out at scheduled timepoints.
The participants will return to the CRU on Day 10, 15, 29, 50, 71, 92, 106 and 127 for blood sampling, safety, and other assessments such as vital signs, ECG, and laboratory test etc.
GB18 will be administered to participants at a starting dose of 50 mg and increasing to 100, 200, 400 and 600 mg in sequential dosing cohorts. The Safety Review Committee (SRC) will assess the safety data, PK data and available PD data at least up to Day 15 (Cohort A1-2)/29 (Cohort A3-5) after the dose administration of each cohort, and a decision of whether to escalate to the next higher dose level or adjust the dose or discontinue dosing will be made by the SRC.
For the safety of participants, 2 sentinel participants will be randomly dosed (GB18: placebo=1:1) at least 24 hours before the remaining participants in the cohort receive dosing, except for Cohort A1. Once safety is confirmed, the remaining participants will be dosed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| A1-50mg-GB18 | Experimental | Drug: GB18 injection |
| A1-50mg-placebo | Placebo comparator | Drug: Placebo |
| A2-100mg-GB18 | Experimental | Drug: GB18 injection |
| A2-100mg-placebo | Placebo comparator | Drug: Placebo |
| A3-200mg-GB18 | Experimental | Drug: GB18 injection |
| A3-200mg-placebo | Placebo comparator | Drug: Placebo |
| A4-400mg-GB18 | Experimental | Drug: GB18 injection |
| A4-400mg-placebo | Placebo comparator | Drug: Placebo |
| A5-600mg-GB18 | Experimental | Drug: GB18 injection |
| A5-600mg-placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Participants who have signed the informed consent form (ICF) prior to the study, fully understand the content, procedures, and possible adverse reactions of the study, and are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
- Male and female participants aged 18-55 years (inclusive), at the time of signing the ICF.
- Body weight ≥ 50 kg for males and ≥ 45 kg for females, with a body mass index (BMI = weight (kg)/height 2 (m) 2) of 18.5-26 kg/m2 (inclusive).
- Male and female participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, Vital signs, 12-lead ECG, and laboratory tests.
- Participants (including their partners) who have no plan to become pregnant and voluntarily use effective contraception from screening to 6 months after the last dose.
Key exclusion criteria (21 listed)
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
- History of HIV infection, syphilis, hepatitis B, or hepatitis C; positive testing for HIV, syphilis, HBsAg, or HCVAb.
- History of allergic or anaphylactic reaction to any therapeutic or diagnostic monoclonal antibody or molecules made of components of monoclonal antibodies.
- History of recurrent infections or active infections.
- Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior, or other conditions that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
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 |
|---|---|---|
| GB18 injectionGB18 will be administered to participants at a starting dose of 50 mg and increasing to 100, 200, 400 and 600 mg in sequential dosing cohorts. | Drug | A1-50mg-GB18, A2-100mg-GB18, A3-200mg-GB18, A4-400mg-GB18, A5-600mg-GB18 |
| PlaceboPlacebo will be administered to participants at doses matching GB18. | Drug | A1-50mg-placebo, A2-100mg-placebo, A3-200mg-placebo, A4-400mg-placebo, A5-600mg-placebo |
Primary outcome
Number of adverse events as assessed by CTCAE v5.0
Time frame: From pre-dosing to the end of follow-up at 18 weeks
The number of AEs (e.g., abnormalities in laboratory tests, vital signs, physical examinations, and 12-lead ECGs) will be recorded and analyzed.
3 secondary outcomes
Serum pharmacokinetics parameters (Cmax, Tmax, AUC0-inf, AUC0-t, λz, t1/2, Vz/F, and CL/F).
Time frame: From pre-dosing to the end of follow-up at 18 weeks
Serum concentrations of total and, if feasible, unbound GDF15 specified in the schedule of activities.
Time frame: From pre-dosing to the end of follow-up at 18 weeks
(if applicable) Incidence of ADA and Nab
Time frame: From pre-dosing to the end of follow-up at 18 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 19 Nov 2025.
- Background: PubMed 36769245Joo M, Kim D, Lee MW, Lee HJ, Kim JM. GDF15 Promotes Cell Growth, Migration, and Invasion in Gastric Cancer by Inducing STAT3 Activation. Int J Mol Sci. 2023 Feb 2;24(3):2925. doi: 10.3390/ijms24032925.
- Background: PubMed 26249737Tsui KH, Hsu SY, Chung LC, Lin YH, Feng TH, Lee TY, Chang PL, Juang HH. Growth differentiation factor-15: a p53- and demethylation-upregulating gene represses cell proliferation, invasion, and tumorigenesis in bladder carcinoma cells. Sci Rep. 2015 Aug 7;5:12870. doi: 10.1038/srep12870.
- Background: PubMed 26672741Lerner L, Hayes TG, Tao N, Krieger B, Feng B, Wu Z, Nicoletti R, Chiu MI, Gyuris J, Garcia JM. Plasma growth differentiation factor 15 is associated with weight loss and mortality in cancer patients. J Cachexia Sarcopenia Muscle. 2015 Dec;6(4):317-24. doi: 10.1002/jcsm.12033. Epub 2015 Apr 30.
- Background: PubMed 34638326Suzuki H, Mitsunaga S, Ikeda M, Aoyama T, Yoshizawa K, Yoshimatsu H, Kawai N, Masuda M, Miura T, Ochiai A. Clinical and Tumor Characteristics of Patients with High Serum Levels of Growth Differentiation Factor 15 in Advanced Pancreatic Cancer. Cancers (Basel). 2021 Sep 28;13(19):4842. doi: 10.3390/cancers13194842.
- Background: PubMed 33790859Niu Y, Zhang W, Shi J, Liu Y, Zhang H, Lin N, Li X, Qin L, Yang Z, Su Q. The Relationship Between Circulating Growth Differentiation Factor 15 Levels and Diabetic Retinopathy in Patients With Type 2 Diabetes. Front Endocrinol (Lausanne). 2021 Mar 15;12:627395. doi: 10.3389/fendo.2021.627395. eCollection 2021.
- Background: PubMed 34836750Siddiqui JA, Pothuraju R, Khan P, Sharma G, Muniyan S, Seshacharyulu P, Jain M, Nasser MW, Batra SK. Pathophysiological role of growth differentiation factor 15 (GDF15) in obesity, cancer, and cachexia. Cytokine Growth Factor Rev. 2022 Apr;64:71-83. doi: 10.1016/j.cytogfr.2021.11.002. Epub 2021 Nov 17.
- Background: PubMed 30382947Tsai VW, Brown DA, Breit SN. Targeting the divergent TGFbeta superfamily cytokine MIC-1/GDF15 for therapy of anorexia/cachexia syndromes. Curr Opin Support Palliat Care. 2018 Dec;12(4):404-409. doi: 10.1097/SPC.0000000000000384.
- Background: PubMed 32508832Wischhusen J, Melero I, Fridman WH. Growth/Differentiation Factor-15 (GDF-15): From Biomarker to Novel Targetable Immune Checkpoint. Front Immunol. 2020 May 19;11:951. doi: 10.3389/fimmu.2020.00951. eCollection 2020.
- Background: PubMed 33735441Grande AJ, Silva V, Sawaris Neto L, Teixeira Basmage JP, Peccin MS, Maddocks M. Exercise for cancer cachexia in adults. Cochrane Database Syst Rev. 2021 Mar 18;3(3):CD010804. doi: 10.1002/14651858.CD010804.pub3.
- Background: PubMed 33585533Balstad TR, Brunelli C, Pettersen CH, Schonberg SA, Skorpen F, Fallon M, Kaasa S, Bye A, Laird BJA, Stene GB, Solheim TS. Power Comparisons and Clinical Meaning of Outcome Measures in Assessing Treatment Effect in Cancer Cachexia: Secondary Analysis From a Randomized Pilot Multimodal Intervention Trial. Front Nutr. 2021 Jan 14;7:602775. doi: 10.3389/fnut.2020.602775. eCollection 2020.
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- Background: PubMed 37116469Ferrer M, Anthony TG, Ayres JS, Biffi G, Brown JC, Caan BJ, Cespedes Feliciano EM, Coll AP, Dunne RF, Goncalves MD, Grethlein J, Heymsfield SB, Hui S, Jamal-Hanjani M, Lam JM, Lewis DY, McCandlish D, Mustian KM, O'Rahilly S, Perrimon N, White EP, Janowitz T. Cachexia: A systemic consequence of progressive, unresolved disease. Cell. 2023 Apr 27;186(9):1824-1845. doi: 10.1016/j.cell.2023.03.028.
- 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.
1 site 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 injection in people with Cancer Cachexia (CC) and Cancer Cachexia, run by Shenzhen Kexing Pharmaceutical Co., Ltd. at 1 site 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 5 inclusion and 21 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 19 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. 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 Kangsheng Yang (400-888-9496, yangkangsheng@kexing.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of adverse events as assessed by CTCAE v5.0 (time frame: From pre-dosing to the end of follow-up at 18 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07237464, which also lists 19 linked publications.
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 19 Nov 2025.