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

NCT07631793 | Not Yet Recruiting Phase 1

• 1 other identifier: CLSP-YKYY031-Z01
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Malignant Neoplasms

Outcome Measures

Primary Outcomes (3)

• Incidence of Dose-Limiting Toxicity (DLT)

  DLT assessment: 28 days post-first dose

• Treatment-Emergent Adverse Events (TEAEs)

  Safety assessments: from first dose until the 28 days after the last dose

• Serious Adverse Events (SAEs)

  Safety assessments: from first dose until the 28 days after the last dose

Secondary Outcomes (15)

• Cmax

  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

  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

  Every 8 weeks from first dose until disease progression or death (assessed up to 2 years)

• Disease Control Rate (DCR) per RECIST v1.1

  Every 8 weeks from first dose until disease progression or death (assessed up to 2 years)

• Duration of Response (DOR) per RECIST v1.1

  From first documented Complete response (CR) / Partial response (PR) to first documented Disease progression (PD) or death (assessed up to 2 years)

Study Arms (1)

YKYY031 for injection

EXPERIMENTAL

intramuscular, a single intramuscular injection of the corresponding dose of YKYY031 for injection

Drug: YKYY031 group (the first stage); Drug: YKYY031 group (the second stage)

Interventions

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 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.

YKYY031 for injection

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female patients aged 18 to 75 years old at the time of signing the informed consent form.
• Histologically or cytologically confirmed advanced or metastatic solid tumors that have failed standard therapy and have no effective treatment options, including but not limited to colorectal cancer, pancreatic cancer, etc.
• For colorectal cancer (CRC) patients, prior receipt of at least second-line standard therapy failure and no effective treatment options; adjuvant/neoadjuvant chemotherapy failure during or within 6 months after the last treatment is considered first-line failure.
• For pancreatic cancer patients, prior receipt of at least first-line standard therapy failure and no effective treatment options; adjuvant/neoadjuvant chemotherapy failure during or within 6 months after the last treatment is considered first-line failure.
• Patients must have human leukocyte antigen (HLA) subtype HLA-A\*11:01.
• Patients must test positive for at least one of the tumor-specific antigens (TSA) targeted by YKYY031, including KRAS G12D, KRAS G12C, KRAS G12V, KRAS G13D, KRAS G12R, KRAS G12S, PIK3CA E542K, TP53 R248Q, PIK3CA E545K, BRAF V600E, PIK3CA H1047L, FBXW7 R465C.
• Eastern Cooperative Oncology Group (ECOG) performance status score: 0-1.
• Expected survival duration ≥ 3 months.
• At least one measurable lesion (non-nodal lesions with longest diameter ≥10 mm, nodal lesions with shortest diameter ≥15 mm) according to RECIST V1.1.
• Major organ function is good, meeting the following requirements:
• Hemoglobin ≥90 g/L, absolute neutrophil count ≥1.5×10⁹/L, platelet count ≥80×10⁹/L within 14 days prior to the first dose, without the use of hematopoietic growth factors, blood transfusions, blood products, albumin, or blood products.
• Total bilirubin ≤1.5× upper limit of normal (ULN); if liver metastasis or Gilbert's syndrome is present, total bilirubin ≤3×ULN.
• Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤3×ULN; if liver metastasis is present, ALT or AST ≤5×ULN.
• Serum creatinine ≤1.5×ULN or creatinine clearance ≥50 mL/min (calculated using the Cockcroft-Gault formula).
• Prothrombin time ≤1.5×ULN (unless using warfarin anticoagulation). International normalized ratio (INR) ≤1.5×ULN (unless using warfarin anticoagulation).

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.

Sponsors & Collaborators

• Beijing Youcare Kechuang Pharmaceutical Technology Co., Ltd.: lead

Study Sites (1)

Beijing Youcare Kechuang Pharmaceutical Technology Co., Ltd.

Beijing, Beijing Municipality, 100176, China

Location

MeSH Terms

Conditions

Neoplasms

Central Study Contacts

Yuting Zhou

CONTACT

+86 18606417018; zhouyuting@bjykkc.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2026
• First Posted: June 8, 2026
• Study Start: May 30, 2026
• Primary Completion (Estimated): December 8, 2027
• Study Completion (Estimated): December 7, 2030
• Last Updated: June 8, 2026

Record last verified: 2026-05

Locations

CN (1)