Phase I Clinical Trial of YKYY031 for Injection in Patients With Advanced Solid Tumors

Starting soon · Phase 1

Conditions studied: Malignant Neoplasms

In brief

Phase I study of YKYY031 for injection in patients with advanced solid tumors

Key facts

Study ID

NCT07631793

Run by

Beijing Youcare Kechuang Pharmaceutical Technology Co., Ltd.

People needed

76

Starts

2026-05-30

Expected to finish

2030-12-07

Last updated by the study team

2026-06-08

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• 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)
• 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.

Where it is running

• Beijing Youcare Kechuang Pharmaceutical Technology Co., Ltd. — Beijing, Beijing Municipality, China

Full record on ClinicalTrials.gov

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