NeoplasmsPhase 1NCT06175780
Phase I Study of KY-0118 in Subjects With Locally Advanced or Metastatic Solid Tumors
A Phase 1 study testing KY-0118 in people with Neoplasms and Neoplasms by Histologic Type, run by Novatim Immune Therapeutics (Zhejiang) Co., Ltd. at 8 sites in China.
Trial summary
This dose escalation and dose expansion study is to evaluate and characterize the tolerability, safety, pharmacokinetics and efficacy profile of single agent KY-0118 in Locally Advanced or Metastatic Solid Tumor Patients. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Neoplasms, Neoplasms by Histologic Type
- What is being tested?
- KY-0118
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 189 participants
- Where
- 8 sitesChina
- Study dates
- 28 Dec 2022to 28 Dec 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years old and ≤75 years old, male or female;
- Subjects with a documented (histologically- or cytologically-proven) solid tumor malignancy that is locally advanced or metastatic; progression or are intolerant to existing standard therapy or subjects without standard therapy;
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1；Expected survival time≥ 12 weeks;
- At least one measurable lesion per RECIST 1.1 (without local treatment or progress after local treatment);
- Adequate organ function;
- Toxicity from prior anticancer therapy recovered to ≤ grade 1 prior to the first dose of study drugs;
- Signed informed consent and willingly adherence to the experimental treatment protocol and visit plan.
Who cannot join
- Specific anti-tumor treatment prior to use of study treatment;
- Immunosuppressants or systemic hormone therapy were being used and were not discontinued within 2 weeks prior to enrollment;
- IL-2 treatment within 6 months prior to the first dose of study drugs;
- Any immune related adverse events (irAE) that have occurred during previous immunotherapy medication, with a grade of ≥ 3 or leading to termination of immunotherapy;
- Primary Central Nervous System (CNS) Malignant Tumors or Active CNS Metastasis with Local Treatment Failure;
- Any severe and/or uncontrolled diseases, including but not limited to: uncontrolled hypertension or pulmonary hypertension or unstable angina; Chronic heart failure; Valve disease; Severe arrhythmia; Had myocardial infarction or bypass or stent surgery within 6 months before screening;
Show all 24Show fewer
- History of arteriovenous thromboembolism within 6 months prior to screening；
- Moderate or severe respiratory distress at rest due to advanced malignant tumors or their complications or severe primary lung diseases；or a current need for continuous oxygen therapy, or a current history of interstitial lung disease (ILD) or pneumonia, severe chronic obstructive pulmonary disease, severe pulmonary insufficiency, symptomatic bronchospasm, etc. ;
- Uncontrolled bleeding or known tendency to bleed; Patients with chronic Crohn's disease and ulcerative colitis;Patients with hereditary nonpolyposis colorectal cancer or familial adenomatous polyposis syndrome;Patients with a history of intestinal perforation and fistula, but not cured after surgical treatment;Esophagogastric varices;
- Third space effusion that cannot be controlled by puncture and drainage treatment and require repeated drainage or have obvious symptoms;
- Patients who require extensive fluid replacement assessed by investigators;
- Active hepatitis B or active hepatitis C;
- Active infectious process;
- A history of immunodeficiency;
- Autoimmune diseases, including but not limited to systemic lupus erythematosus, psoriasis, rheumatoid arthritis, inflammatory bowel disease, Hashimoto's thyroiditis, autoimmune thyroid disease, multiple sclerosis, etc.;
- Patients with allergic constitution, or known to have a history of allergy to IL-2 or PD-1/PD-L1 drugs or any of their components, or known to have a history of severe allergic reactions to fusion proteins;
- History of other malignancies within 5 years prior to screening;
- Surgery (other than diagnostic biopsy) within 4 weeks prior to screening or planned to have surgery during the study period;
- Had received live vaccine within 4 weeks before the first dose or planned to receive live vaccine during the trial;
- History of neurological or psychiatric disorders, such as epilepsy, dementia, altered mental status, and poor compliance;
- History of alcohol or drug abuse within the last 1 year;
- Women who are pregnant or breastfeeding. Patients unwilling to use a highly effective method of contraception during the study period and for 6 months after receiving the trial drug;
- Attended other study within 4 weeks prior to screening;
- Other conditions deemed unsuitable for inclusion by the investigators.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
China8 sites, 8 recruiting
- Recruiting
The Fifth Medical Center of the Chinese PLA General Hospital
Beijing, Beijing Municipality, 100853
Guanghai Dai, professor, daigh60@sohu.com
Guanghai Dai, professor
- Recruiting
The First Affiliated Hospital Bengbu Medical College
Bengbu, Anhui, 233030
Huan Zhou, zhouhuanbest@163.com
Huan Zhou, M.D.
- Recruiting
Fujian Cancer Hospital
Fuzhou, Fujian, 350014
Yu Chen, M.D., 13859089836@139.com
Yu Chen, M.D.
- Not yet recruiting
Zhejiang Province Tumor Hospital
Hangzhou, Zhejiang
Meiyu Fang, M.D., fangmy@zicc.org.cn
Meiyu Fang, M.D.
- Recruiting
Qilu Hospital of Shandong University
Jinan, Shandong, 276600
Benkang Shi, M.D., bkang68@sdu.edu.cn
Benkang Shi, M.D.
- Recruiting
The Second People's Hospital of Liaocheng
Liaocheng, Shandong, 252000
Yanjun Wang, M.D., wangyanjun7809@163.com
Yanjun Wang, M.D.
- Recruiting
Tianjin Cancer Hospital
Tianjin, Tianjin Municipality, 300060
Yehui Shi, shiyehui@tom.com
Yehui Shi, M.D.
- Recruiting
Hubei Province Tumor Hospital
Wuhan, Hubei, 430079
Xinjun Liang, Doctorlxj@163.com
Liang Xinjun, Doctor
About this study
Official title: A Phase I Study to Evaluate the Safety, Tolerability and Pharmacokinetics of KY-0118 in Subjects With Locally Advanced or Metastatic Solid Tumors
This dose escalation and dose expansion study is to evaluate and characterize the tolerability, safety, pharmacokinetics and efficacy profile of single agent KY-0118 in Locally Advanced or Metastatic Solid Tumor Patients.
Read the detailed description
For Phase Ia It aims to evaluate the safety, tolerability, pharmacokinetic characteristics, pharmacodynamic effect, immunogenicity in subjects with locally advanced or metastatic solid tumor patients , and determine the appropriate dose of KY-0118.
For Phase Ib it aims is to further evaluate the efficacy, safety, tolerability, pharmacokinetic properties, pharmacodynamic effects and immunogenicity of KY-0118 with appropriate dose groups (approximately 3-5 dose groups) in different Administration manner.
- Conditions
- Neoplasms, Neoplasms by Histologic Type
- Being tested
- KY-0118
- Medical subject headings
- Neoplasms, Neoplasms by Histologic Type
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KY-0118Drug
KY-0118 is to be injected intravenously with a dose of 0.3μg/kg, 1μg/kg, 3μg/kg, 6μg/kg, 12μg/kg, 24μg/kg, 36μg/kg, 48μg/kg or 64μg/kg until disease progresses or unacceptable tolerability occurs;
KY-0118Drug
KY-0118 is to be injected intravenously with a dose of dose1~dose5 weekly until disease progresses or unacceptable tolerability occurs;
KY-0118Drug
KY-0118 is to be injected subcutaneously with a dose of dose1~dose5 weekly until disease progresses or unacceptable tolerability occurs;
| Study group | Role | What they receive |
|---|---|---|
| KY-0118 | Experimental | Not described Receives: Drug: KY-0118 |
| Cohort1: KY-0118 | Experimental | Not described Receives: Drug: KY-0118 |
| Cohort2: KY-0118 | Experimental | Not described Receives: Drug: KY-0118 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with dose-limiting toxicity (DLT)
Measured: 21 days during the first 3-week cycle
Adverse Event
Incidence of untoward medical occurrences (adverse event = AE) in a participant who received study drug. Adverse events will be evaluated by dosing cohort and recorded according to NCI CTCAE Version 5.0.
Measured: Up to 28 days post last dose
Secondary outcomes (24)
Cmax
Peak expansion
Measured: Up to 7 days post last dose
Ctrough
Trough concentration
Measured: Up to 7 days post last dose
Tmax
time to peak expansion
Measured: Up to 7 days post last dose
T1/2
Elimination half-life
Measured: Up to 7 days post last dose
AUC
Area under curve
Measured: Up to 7 days post last dose
CL
Clearance rate
Measured: Up to 7 days post last dose
Regulatory t cells（Tregs）
Levels of Tregs in peripheral blood at baseline and during administration;
Measured: Up to 7 days post last dose
CD4+ T lymphocyte count
Levels of CD8+ T lymphocyte count in peripheral blood at baseline and during administration;
Measured: Up to 7 days post last dose
CD8+ T lymphocyte count
Levels of CD8+ T lymphocyte count in peripheral blood at baseline and during administration;
Measured: Up to 7 days post last dose
NK cells count
Levels of NK cells count in peripheral blood at baseline and during administration;
Measured: Up to 7 days post last dose
IL-6
Levels of IL-6 in peripheral blood at baseline and during administration;
Measured: Up to 7 days post last dose
IFN-γ
Levels of IFN-γ in peripheral blood at baseline and during administration;
Measured: Up to 7 days post last dose
TNF-ɑ
Levels of TNF-ɑ in peripheral blood at baseline and during administration;
Measured: Up to 7 days post last dose
Granzyme B
Levels of Granzyme B in peripheral blood at baseline and during administration;
Measured: Up to 7 days post last dose
Perforin
Levels of perforin in peripheral blood at baseline and during administration;
Measured: Up to 7 days post last dose
Objective response rate (ORR)
To evaluate the preliminary antitumor activity of KY-0118
Measured: Up to 28 days post last dose
Progression-free survival (PFS)
To evaluate the preliminary antitumor activity of KY-0118
Measured: Up to 28 days post last dose
Duration of response(DOR)
To evaluate the preliminary antitumor activity of KY-0118
Measured: Up to 28 days post last dose
Disease control rate (DCR)
To evaluate the preliminary antitumor activity of KY-0118
Measured: Up to 28 days post last dose
The incidence of ADA of KY-0118
Each subject will be tested for anti-drug (KY-0118) antibody (ADA)
Measured: Up to 7 days post last dose
The incidence of NAb of KY-0118
Each subject with ADA-positive serum samples will continue to be tested for neutralizing antibodies (NAb)
Measured: Up to 7 days post last dose
PD-1 receptor occupancy rate
Measured: Up to 7 days post last dose
IL-2 receptor occupancy rate
IL-2 receptor occupancy of Nk cells, CD8+ T lymphocyte and CD4+T lymphocyte
Measured: Up to 7 days post last dose
Ki67 phenotype
Ki67 phenotype of Nk cells and CD8+T lymphocyte
Measured: Up to 7 days post last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2023
- Study start28 Dec 2022
- Primary completion28 Dec 2025 (estimated)
- Study completion28 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeoplasmsStudies 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
- 189 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Novatim Immune Therapeutics (Zhejiang) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06175780
- Sponsor's protocol ID
- KY-0118-ZJKY
- Status last verified
- Dec 2023
- First submitted
- 29 Nov 2023
- Last updated
- 26 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study to Evaluate the Safety, Tolerability and Pharmacokinetics of KY-0118 in Subjects With Locally Advanced or Metastatic Solid Tumors
- ClinicalTrials.gov ID
- NCT06175780
- Acronym / sponsor ID
- KY-0118-ZJKY
- Conditions
- Neoplasms, Neoplasms by Histologic Type
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 189 participants (estimated)
- Lead sponsor
- Novatim Immune Therapeutics (Zhejiang) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 28 Dec 2022 (actual)
- Primary completion
- 28 Dec 2025 (estimated)
- Study completion
- 28 Dec 2025 (estimated)
- First posted
- 19 Dec 2023 (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 dose escalation and dose expansion study is to evaluate and characterize the tolerability, safety, pharmacokinetics and efficacy profile of single agent KY-0118 in Locally Advanced or Metastatic Solid Tumor Patients.
Detailed description
For Phase Ia It aims to evaluate the safety, tolerability, pharmacokinetic characteristics, pharmacodynamic effect, immunogenicity in subjects with locally advanced or metastatic solid tumor patients , and determine the appropriate dose of KY-0118.
For Phase Ib it aims is to further evaluate the efficacy, safety, tolerability, pharmacokinetic properties, pharmacodynamic effects and immunogenicity of KY-0118 with appropriate dose groups (approximately 3-5 dose groups) in different Administration manner.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| KY-0118 | Experimental | Drug: KY-0118 |
| Cohort1: KY-0118 | Experimental | Drug: KY-0118 |
| Cohort2: KY-0118 | Experimental | Drug: KY-0118 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥18 years old and ≤75 years old, male or female;
- Subjects with a documented (histologically- or cytologically-proven) solid tumor malignancy that is locally advanced or metastatic; progression or are intolerant to existing standard therapy or subjects without standard therapy;
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1；Expected survival time≥ 12 weeks;
- At least one measurable lesion per RECIST 1.1 (without local treatment or progress after local treatment);
- Adequate organ function;
Key exclusion criteria (24 listed)
- Specific anti-tumor treatment prior to use of study treatment;
- Immunosuppressants or systemic hormone therapy were being used and were not discontinued within 2 weeks prior to enrollment;
- IL-2 treatment within 6 months prior to the first dose of study drugs;
- Any immune related adverse events (irAE) that have occurred during previous immunotherapy medication, with a grade of ≥ 3 or leading to termination of immunotherapy;
- Primary Central Nervous System (CNS) Malignant Tumors or Active CNS Metastasis with Local Treatment Failure;
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 |
|---|---|---|
| KY-0118KY-0118 is to be injected intravenously with a dose of 0.3μg/kg, 1μg/kg, 3μg/kg, 6μg/kg, 12μg/kg, 24μg/kg, 36μg/kg, 48μg/kg or 64μg/kg until disease progresses or unacceptable tolerability occurs; | Drug | KY-0118 |
| KY-0118KY-0118 is to be injected intravenously with a dose of dose1~dose5 weekly until disease progresses or unacceptable tolerability occurs; | Drug | Cohort1: KY-0118 |
| KY-0118KY-0118 is to be injected subcutaneously with a dose of dose1~dose5 weekly until disease progresses or unacceptable tolerability occurs; | Drug | Cohort2: KY-0118 |
Primary outcome
Number of patients with dose-limiting toxicity (DLT)
Time frame: 21 days during the first 3-week cycle
Adverse Event
Time frame: Up to 28 days post last dose
Incidence of untoward medical occurrences (adverse event = AE) in a participant who received study drug. Adverse events will be evaluated by dosing cohort and recorded according to NCI CTCAE Version 5.0.
24 secondary outcomes
Cmax
Time frame: Up to 7 days post last dose
Ctrough
Time frame: Up to 7 days post last dose
Tmax
Time frame: Up to 7 days post last dose
T1/2
Time frame: Up to 7 days post last dose
AUC
Time frame: Up to 7 days post last dose
CL
Time frame: Up to 7 days post last dose
Regulatory t cells（Tregs）
Time frame: Up to 7 days post last dose
CD4+ T lymphocyte count
Time frame: Up to 7 days post last dose
CD8+ T lymphocyte count
Time frame: Up to 7 days post last dose
NK cells count
Time frame: Up to 7 days post last dose
IL-6
Time frame: Up to 7 days post last dose
IFN-γ
Time frame: Up to 7 days post last dose
TNF-ɑ
Time frame: Up to 7 days post last dose
Granzyme B
Time frame: Up to 7 days post last dose
Perforin
Time frame: Up to 7 days post last dose
Objective response rate (ORR)
Time frame: Up to 28 days post last dose
Progression-free survival (PFS)
Time frame: Up to 28 days post last dose
Duration of response(DOR)
Time frame: Up to 28 days post last dose
Disease control rate (DCR)
Time frame: Up to 28 days post last dose
The incidence of ADA of KY-0118
Time frame: Up to 7 days post last dose
The incidence of NAb of KY-0118
Time frame: Up to 7 days post last dose
PD-1 receptor occupancy rate
Time frame: Up to 7 days post last dose
IL-2 receptor occupancy rate
Time frame: Up to 7 days post last dose
Ki67 phenotype
Time frame: Up to 7 days post last dose
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2023.
- Individual participant dataSharing planned: Undecided
Related trials for Neoplasms
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
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. This study is not recruiting at the moment.
8 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 KY-0118 in people with Neoplasms and Neoplasms by Histologic Type, run by Novatim Immune Therapeutics (Zhejiang) Co., Ltd. at 8 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 7 inclusion and 24 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: status not confirmed, as of the sponsor's last update on 26 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact si li (17879528905, s.li@novatim-zj.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with dose-limiting toxicity (DLT) (time frame: 21 days during the first 3-week cycle). The study lists 2 primary outcomes in all. 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 26 Dec 2023.