Malignant NeoplasmsPhase 1YKYY031，tumorsNCT07631793
Phase I Clinical Trial of YKYY031 for Injection in Patients With Advanced Solid Tumors
A Phase 1 study testing YKYY031 group (the first stage) and YKYY031 group (the second stage) in people with Malignant Neoplasms, run by Beijing Youcare Kechuang Pharmaceutical Technology Co., Ltd. at 2 sites in China.
Trial summary
Phase I study of YKYY031 for injection in patients with advanced solid tumors Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Malignant Neoplasms
- What is being tested?
- YKYY031 group (the first stage) and YKYY031 group (the second stage)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 2 sitesChina
- Study dates
- 10 Mar 2026to 7 Dec 2030
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Participants meeting any of the following criteria will be excluded
- Allergy to the investigational product (including any excipients). History of severe allergy to any drug, food, or vaccine, such as anaphylactic shock, angioneurotic edema, allergic dyspnea, anaphylactoid purpura, thrombocytopenic purpura, Arthus reaction, etc.
- History of other malignancies, except for cured skin basal cell carcinoma, skin squamous cell carcinoma, superficial bladder cancer, cervical carcinoma in situ, etc., that have not recurred within 5 years prior to screening, as judged by the investigator to be eligible for enrollment.
- Symptomatic central nervous system metastasis or meningeal metastasis, or other evidence indicating uncontrolled central nervous system metastasis or meningeal metastasis, as judged by the investigator to be unsuitable for enrollment. Patients with stable brain metastases (no imaging progression within 4 weeks, and not requiring corticosteroid treatment for at least 4 weeks before the first dose of the study drug) may be enrolled.
- Significant clinically significant cardiovascular diseases, including but not limited to:
- Congestive heart failure (New York Heart Association [NYHA] class > II)
Show all 30Show fewer
- Myocardial infarction, unstable angina, severe pericardial disease, severe myocardial disease within the past 6 months
- Need for treatment of valvular regurgitation or stenosis
- Any supraventricular or ventricular arrhythmia requiring treatment or intervention; uncontrolled malignant arrhythmia; complete left bundle branch block, second- or third-degree atrioventricular block
- QT interval (QTcF) >450 ms in males, >470 ms in females
- Uncontrolled hypertension (defined as systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg despite treatment with two or three antihypertensive agents)
- Any active autoimmune disease or history of autoimmune disease, including but not limited to immunologically related neurological diseases, multiple sclerosis, autoimmune (demyelinating) neuropathy, Guillain-Barré syndrome, myasthenia gravis, systemic lupus erythematosus, connective tissue disease, scleroderma, autoimmune hepatitis, toxic epidermal necrolysis, or Stevens-Johnson syndrome (except for type 1 diabetes mellitus on a stable dose of insulin, hypothyroidism on stable hormone replacement therapy, etc.).
- Any uncontrolled clinical disease (e.g., respiratory, circulatory, neurological, hematological, genitourinary, endocrine system diseases) or psychiatric disease (e.g., depression, schizophrenia) or other major illness, as judged by the investigator to interfere with providing informed consent, interpretation of trial results, participation in the trial posing risks to the participant, or otherwise affecting the achievement of trial objectives, including uncontrolled pleural effusion, pericardial effusion, or ascites as judged by the investigator.
- Known history of interstitial pneumonia or high suspicion of interstitial pneumonia; or presence of pulmonary abnormalities that may interfere with the detection or management of suspected drug-related pulmonary toxicity during the trial.
- Any abnormality at the injection site that, as judged by the investigator, would hinder observation of local reactions at the injection site.
- Presence of contraindications to intramuscular injection.
- Received any antitumor therapy (including chemotherapy, targeted therapy, immunotherapy, etc.) or participated in another drug or device clinical trial within 4 weeks or 5 half-lives (whichever is shorter) prior to the first dose; received traditional Chinese medicine or patent Chinese medicine with clear antitumor indications within 2 weeks prior to the first dose.
- Previous antitumor treatment-related adverse events that have not recovered to ≤ grade 1 according to CTCAE, except for toxicities judged by the investigator to have no safety risk, such as alopecia, grade 2 peripheral neurotoxicity, hypothyroidism stabilized by hormone replacement therapy, etc.
- Prior organ transplantation or allogeneic hematopoietic stem cell transplantation.
- Use of corticosteroids (>10 mg/day prednisone or equivalent other glucocorticoids) or other immunosuppressants for systemic treatment within 14 days prior to the first dose of the vaccine. Inhaled or topical steroids and adrenal hormone replacement at doses ≤10 mg/day prednisone are allowed in the absence of active autoimmune disease.
- Received live/attenuated live/inactivated vaccines within 4 weeks prior to the first dose of the vaccine.
- Prior receipt of a therapeutic tumor vaccine targeting the same antigen.
- Bleeding disorders (e.g., coagulation factor deficiency, coagulation dysfunction [as judged by the investigator to be unsuitable for enrollment]), or a history of significant bruising or bleeding after injection or blood draw.
- Blood donation or significant blood loss (>450 mL) within 3 months prior to screening, or planned blood or blood component donation during the study period.
- Major surgery within 4 weeks prior to screening (minor procedures such as catheter placement and biopsy required by the protocol are not exclusionary), or unresolved effects of surgery or trauma within 14 days prior to enrollment.
- History of substance abuse or known medical, psychological, or social conditions, such as alcoholism or drug addiction.
- Positive human immunodeficiency virus antibody test result, active syphilis (defined as positive syphilis antibody test and positive reagin test), active hepatitis B (defined as hepatitis B virus [HBV] DNA ≥2000 IU/mL), or active hepatitis C (defined as hepatitis C virus [HCV] RNA test positive).
- Active tuberculosis (TB) (patients suspected of having active TB require further consultation with the infectious disease department for definitive diagnosis) or history of active TB; or severe acute or chronic infection requiring systemic treatment.
- Pregnant or breastfeeding women.
- Any other condition deemed by the investigator to make the participant unsuitable for participation in this trial.
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
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142
Yuting Zhou, +86 18606417018, zhouyuting@bjykkc.com
- Not yet recruiting
Beijing Youcare Kechuang Pharmaceutical Technology Co., Ltd.
Beijing, Beijing Municipality, 100176
Yuting Zhou, +86 18606417018, zhouyuting@bjykkc.com
About this study
Official title: Phase I Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of YKYY031 for Injection in Patients With Advanced Solid Tumors
Phase I study of YKYY031 for injection in patients with advanced solid tumors
Read the detailed description
This is a open-label, dose-escalation and dose-expansion Phase 1 clinical study to evaluate the pharmacokinetic (PK) profile, safety, tolerability, and preliminary antitumor activity of YKYY031 Injection in subjects with advanced solid tumors who have failed standard therapy and have no effective treatment options, including but not limited to colorectal cancer and pancreatic cancer.
- Conditions
- Malignant Neoplasms
- Being tested
- YKYY031 group (the first stage), YKYY031 group (the second stage)
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YKYY031 group (the first stage)Drug
Eligible participants selected through screening will be sequentially assigned to dose groups A1 to A6 (in ascending order of dose) according to their enrollment sequence. Each participant will receive a single intramuscular injection of the corresponding dose of YKYY031 for injection.
YKYY031 group (the second stage)Drug
Based on the results of the dose-escalation trial, 1-2 dose groups will be selected for the dose-expansion trial of YKYY031 for injection as monotherapy or in combination with other drugs. Eligible participants will be sequentially assigned to dose groups B1 to B2 (in ascending order of dose) according to their enrollment sequence. Each participant will receive a single intramuscular injection of the corresponding dose of YKYY031 for injection.
| Study group | Role | What they receive |
|---|---|---|
| YKYY031 for injection | Experimental | intramuscular, a single intramuscular injection of the corresponding dose of YKYY031 for injection Receives: Drug: YKYY031 group (the first stage); Drug: YKYY031 group (the second stage) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Dose-Limiting Toxicity (DLT)
Measured: DLT assessment: 28 days post-first dose
Treatment-Emergent Adverse Events (TEAEs)
Measured: Safety assessments: from first dose until the 28 days after the last dose
Serious Adverse Events (SAEs)
Measured: Safety assessments: from first dose until the 28 days after the last dose
Secondary outcomes (15)
Cmax
Peak plasma concentration
Measured: Pre-dose to end of treatment + 28 days (sampling at Day1, Day8, Day15, Day22, Day28, then once every three weeks, assessed up to 2 years）
AUC
Area under the plasma concentration versus time curve
Measured: Pre-dose to end of treatment + 28 days (sampling at Day1, Day8, Day15, Day22, Day28, then once every three weeks, assessed up to 2 years）
Objective Response Rate (ORR) per RECIST v1.1
Measured: Every 8 weeks from first dose until disease progression or death (assessed up to 2 years)
Disease Control Rate (DCR) per RECIST v1.1
Measured: Every 8 weeks from first dose until disease progression or death (assessed up to 2 years)
Duration of Response (DOR) per RECIST v1.1
Measured: From first documented Complete response (CR) / Partial response (PR) to first documented Disease progression (PD) or death (assessed up to 2 years)
Progression-Free Survival (PFS) per RECIST v1.1
Measured: From first dose to first documented PD or death (assessed up to 2 years)
Overall Survival (OS)
Measured: From first dose to death from any cause (assessed up to 2 years)
Immune Objective Response Rate (iORR) per iRECIST
Measured: Every 8 weeks from first dose until disease progression or death (assessed up to 2 years)
Immune Disease Control Rate (iDCR) per iRECIST
Measured: Every 8 weeks from first dose until disease progression or death (assessed up to 2 years)
Immune Duration of Response (iDOR) per iRECIST
Measured: From first documented immune CR/PR to first documented immune progression or death (assessed up to 2 years)
Immune Progression-Free Survival (iPFS) per iRECIST
Measured: From first dose to first documented immune progression or death (assessed up to 2 years)
Incidence of anti-drug antibodies (immunogenicity)
Measured: Pre-dose to end of treatment + 28 days (ssampling at Day1, Day8, Day15, Day22, Day28, then once every three weeks, treatment end/early withdrawal visit, safety follow-up if applicable, assessed up to 2 years)
Antigen-specific T cell levels in PBMC (ELISpot-IFN-γ)
Measured: Pre-dose to end of treatment + 28 days (sampling at Day1, Day8, Day15, Day22, Day28, then once every three weeks, treatment end/early withdrawal visit, safety follow-up if applicable, assessed up to 2 years)
Immune cell subset changes
Measured: Pre-dose to end of treatment + 28 days (sampling at Day1, Day8, Day15, Day22, Day28, then once every three weeks, treatment end/early withdrawal visit, safety follow-up if applicable, assessed up to 2 years)
ctDNA
Biomarkers
Measured: Screening, Day28, then once every three weeks post-Day22, optional tumor tissue sampling as clinically indicated
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2026
- Study start10 Mar 2026
- Primary completion8 Dec 2027 (estimated)
- Study completion7 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Youcare Kechuang Pharmaceutical Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07631793
- Sponsor's protocol ID
- CLSP-YKYY031-Z01
- Acronym
- YKYY031，tumors
- Status last verified
- Aug 2026
- First submitted
- 27 May 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of YKYY031 for Injection in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT07631793
- Acronym / sponsor ID
- YKYY031，tumors / CLSP-YKYY031-Z01
- Conditions
- Malignant Neoplasms
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- Beijing Youcare Kechuang Pharmaceutical Technology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 10 Mar 2026 (actual)
- Primary completion
- 8 Dec 2027 (estimated)
- Study completion
- 7 Dec 2030 (estimated)
- First posted
- 8 Jun 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.
Phase I study of YKYY031 for injection in patients with advanced solid tumors
Detailed description
This is a open-label, dose-escalation and dose-expansion Phase 1 clinical study to evaluate the pharmacokinetic (PK) profile, safety, tolerability, and preliminary antitumor activity of YKYY031 Injection in subjects with advanced solid tumors who have failed standard therapy and have no effective treatment options, including but not limited to colorectal cancer and pancreatic cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| YKYY031 for injection | Experimental | Drug: YKYY031 group (the first stage), Drug: YKYY031 group (the second stage)intramuscular, a single intramuscular injection of the corresponding dose of YKYY031 for injection |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (30 listed)
- Participants meeting any of the following criteria will be excluded
- Allergy to the investigational product (including any excipients). History of severe allergy to any drug, food, or vaccine, such as anaphylactic shock, angioneurotic edema, allergic dyspnea, anaphylactoid purpura, thrombocytopenic purpura, Arthus reaction, etc.
- History of other malignancies, except for cured skin basal cell carcinoma, skin squamous cell carcinoma, superficial bladder cancer, cervical carcinoma in situ, etc., that have not recurred within 5 years prior to screening, as judged by the investigator to be eligible for enrollment.
- Symptomatic central nervous system metastasis or meningeal metastasis, or other evidence indicating uncontrolled central nervous system metastasis or meningeal metastasis, as judged by the investigator to be unsuitable for enrollment. Patients with stable brain metastases (no imaging progression within 4 weeks, and not requiring corticosteroid treatment for at least 4 weeks before the first dose of the study drug) may be enrolled.
- Significant clinically significant cardiovascular diseases, including but not limited to:
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 |
|---|---|---|
| YKYY031 group (the first stage)Eligible participants selected through screening will be sequentially assigned to dose groups A1 to A6 (in ascending order of dose) according to their enrollment sequence. Each participant will receive a single intramuscular injection of the corresponding dose of YKYY031 for injection. | Drug | YKYY031 for injection |
| YKYY031 group (the second stage)Based on the results of the dose-escalation trial, 1-2 dose groups will be selected for the dose-expansion trial of YKYY031 for injection as monotherapy or in combination with other drugs. Eligible participants will be sequentially assigned to dose groups B1 to B2 (in ascending order of dose) according to their enrollment sequence. Each participant will receive a single intramuscular injection of the corresponding dose of YKYY031 for injection. | Drug | YKYY031 for injection |
Primary outcome
Incidence of Dose-Limiting Toxicity (DLT)
Time frame: DLT assessment: 28 days post-first dose
Treatment-Emergent Adverse Events (TEAEs)
Time frame: Safety assessments: from first dose until the 28 days after the last dose
Serious Adverse Events (SAEs)
Time frame: Safety assessments: from first dose until the 28 days after the last dose
15 secondary outcomes
Cmax
Time frame: Pre-dose to end of treatment + 28 days (sampling at Day1, Day8, Day15, Day22, Day28, then once every three weeks, assessed up to 2 years）
AUC
Time frame: Pre-dose to end of treatment + 28 days (sampling at Day1, Day8, Day15, Day22, Day28, then once every three weeks, assessed up to 2 years）
Objective Response Rate (ORR) per RECIST v1.1
Time frame: Every 8 weeks from first dose until disease progression or death (assessed up to 2 years)
Disease Control Rate (DCR) per RECIST v1.1
Time frame: Every 8 weeks from first dose until disease progression or death (assessed up to 2 years)
Duration of Response (DOR) per RECIST v1.1
Time frame: From first documented Complete response (CR) / Partial response (PR) to first documented Disease progression (PD) or death (assessed up to 2 years)
Progression-Free Survival (PFS) per RECIST v1.1
Time frame: From first dose to first documented PD or death (assessed up to 2 years)
Overall Survival (OS)
Time frame: From first dose to death from any cause (assessed up to 2 years)
Immune Objective Response Rate (iORR) per iRECIST
Time frame: Every 8 weeks from first dose until disease progression or death (assessed up to 2 years)
Immune Disease Control Rate (iDCR) per iRECIST
Time frame: Every 8 weeks from first dose until disease progression or death (assessed up to 2 years)
Immune Duration of Response (iDOR) per iRECIST
Time frame: From first documented immune CR/PR to first documented immune progression or death (assessed up to 2 years)
Immune Progression-Free Survival (iPFS) per iRECIST
Time frame: From first dose to first documented immune progression or death (assessed up to 2 years)
Incidence of anti-drug antibodies (immunogenicity)
Time frame: Pre-dose to end of treatment + 28 days (ssampling at Day1, Day8, Day15, Day22, Day28, then once every three weeks, treatment end/early withdrawal visit, safety follow-up if applicable, assessed up to 2 years)
Antigen-specific T cell levels in PBMC (ELISpot-IFN-γ)
Time frame: Pre-dose to end of treatment + 28 days (sampling at Day1, Day8, Day15, Day22, Day28, then once every three weeks, treatment end/early withdrawal visit, safety follow-up if applicable, assessed up to 2 years)
Immune cell subset changes
Time frame: Pre-dose to end of treatment + 28 days (sampling at Day1, Day8, Day15, Day22, Day28, then once every three weeks, treatment end/early withdrawal visit, safety follow-up if applicable, assessed up to 2 years)
ctDNA
Time frame: Screening, Day28, then once every three weeks post-Day22, optional tumor tissue sampling as clinically indicated
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 13 Oct 2026.
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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 YKYY031 group (the first stage) and YKYY031 group (the second stage) in people with Malignant Neoplasms, run by Beijing Youcare Kechuang Pharmaceutical Technology 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 0 inclusion and 30 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 13 Oct 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 Yuting Zhou (+86 18606417018, zhouyuting@bjykkc.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Dose-Limiting Toxicity (DLT) (time frame: DLT assessment: 28 days post-first dose). The study lists 3 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 13 Oct 2026.