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New treatment option for Malignant Tumor
Official title Clinical Study of Novel Therapeutic Vaccine for Advanced Solid Tumors
ClinicalTrials.gov ID: NCT07567222
What this study is testing
What is YMN101?
YMN101 is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for malignant tumor.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Advanced solid tumors remain a major therapeutic challenge due to their complex heterogeneity and the immunosuppressive tumor microenvironment (TME). Although cancer vaccines are designed to induce long-lasting antitumor immunity, their efficacy is often limited by the TME's immune-evasive mechanisms.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Histologically or cytologically confirmed advanced solid tumors, or radiologically diagnosed HCC, eligible for one of the following study parts based...
- Age 18-75 years.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2.
- Life expectancy \> 3 months.
- Adequate organ function within 7 days prior to first dose, including: Hematologic: Hemoglobin (Hb) \>= 80 g/L; White Blood Cell count (WBC) \>= 3.0 x...
You likely can't join if
- Another primary malignancy within 5 years prior to first dose, except for adequately treated non-melanoma skin cancer, carcinoma in situ, or...
- Active central nervous system (CNS) metastases or leptomeningeal disease.
- Positive for infectious diseases, including HIV, active Hepatitis C (HCV RNA positive), or active Hepatitis B (HBsAg or HBcAb positive with HBV DNA...
- Active pulmonary tuberculosis.
- Active autoimmune disease requiring systemic treatment within the past 2 years; or use of systemic corticosteroids (\> 10 mg/day prednisone...
- Major surgery or significant trauma within 28 days prior to enrollment, or presence of unhealed wounds, ulcers, or conditions associated with high...
See the full eligibility criteria
- Histologically or cytologically confirmed advanced solid tumors, or radiologically diagnosed HCC, eligible for one of the following study parts based on tumor type, clinical status, and prior treatment history: Part A1...
- Age 18-75 years.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2.
- Life expectancy \> 3 months.
- Adequate organ function within 7 days prior to first dose, including: Hematologic: Hemoglobin (Hb) \>= 80 g/L; White Blood Cell count (WBC) \>= 3.0 x 10\^9/L; Platelet count (PLT) \>= 80 x 10\^9/L; Absolute Neutrophil...
- At least one measurable or evaluable lesion per RECIST v1.1.
- Ability to understand and sign written informed consent and comply with study procedures.
- Another primary malignancy within 5 years prior to first dose, except for adequately treated non-melanoma skin cancer, carcinoma in situ, or localized low-risk cancers.
- Active central nervous system (CNS) metastases or leptomeningeal disease.
- Positive for infectious diseases, including HIV, active Hepatitis C (HCV RNA positive), or active Hepatitis B (HBsAg or HBcAb positive with HBV DNA \>= 500 IU/mL or \>= 2000 copies/mL).
- Active pulmonary tuberculosis.
- Active autoimmune disease requiring systemic treatment within the past 2 years; or use of systemic corticosteroids (\> 10 mg/day prednisone equivalent) within 4 weeks prior to first dose.
- Major surgery or significant trauma within 28 days prior to enrollment, or presence of unhealed wounds, ulcers, or conditions associated with high risk of bleeding or perforation.
- Arterial/venous thrombosis or pulmonary embolism within 6 months, or CTCAE Grade \>= 3 bleeding event within 28 days prior to treatment.
- Localized conditions at the injection site (e.g., infection, inflammation, or extensive scarring) or clinically significant coagulation disorders that contraindicate subcutaneous or intraosseous administration.
- Known hypersensitivity or intolerance to study treatment components or related compounds.
- Pregnant or breastfeeding, or planning to conceive (participant or partner) during the study.
- Any condition that, in the investigator's judgment, may compromise safety or interfere with study participation or evaluation.
The study team makes the final eligibility decision.
Where it's taking place
- Chengdu, Sichuan, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chengdu, Sichuan, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.