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New treatment option for Advanced Solid Tumors
Official title A Clinical Study of YL205 in Patients With Advanced Solid Tumors
ClinicalTrials.gov ID: NCT06459973
What this study is testing
What is intravenous (IV) infusion?
intravenous (IV) infusion is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for advanced solid tumors.
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
- This study is a multicenter, open-label, phase I/II study of YL205 in China to evaluate the safety, tolerability, PK characteristics and preliminary efficacy of YL205 in the following selected patients with advanced solid tumors.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 1) people who are informed of relevant information of the study prior to initiation of the study and voluntarily sign and date on the informed...
- 2) Age ≥18 years. 3) Be willing to follow and be able to complete all the study procedures. 4) Body mass index (BMI) within the range of 18 to 32...
- 5） Patients with histologically or cytologically confirmed locally advanced or metastatic ovarian cancer (OC), non-squamous non-small cell lung...
- 10) Expected survival ≥3 months. 11) Female people of childbearing potential must agree to take effective contraceptive measures and must not undergo...
- 12) people must provide tumor samples. 13) people who are capable of and willing to comply with the visits and procedures stipulated in the study...
You likely can't join if
- 1) people with a treatment history with drugs targeting Napi2b. 2) people with a history of intolerance to topoisomerase I inhibitors or ADC therapy.
- 3) people who are participating in another clinical study, with the exception an of observational (non-treatment) clinical study or the follow-up...
- 4) people with an insufficient washout period from the previous anti-tumor therapy to the first dose.
- 5) people who received radiotherapy, including palliative stereotactic radiotherapy on the abdomen, within 4 weeks prior to the first dose.
- 6) people who received major surgery within 4 weeks prior to the first dose or those who plan to receive major surgery during the study.
- 7) people who received allogeneic bone marrow transplantation or solid organ transplantation.
See the full eligibility criteria
- 1) people who are informed of relevant information of the study prior to initiation of the study and voluntarily sign and date on the informed consent form (ICF).
- 2) Age ≥18 years. 3) Be willing to follow and be able to complete all the study procedures. 4) Body mass index (BMI) within the range of 18 to 32 kg/m2, and body weight ≥45kg for female people.
- 5） Patients with histologically or cytologically confirmed locally advanced or metastatic ovarian cancer (OC), non-squamous non-small cell lung cancer (NSQ NSCLC), renal cell carcinoma (RCC), endometrial cancer (EC), or...
- 10) Expected survival ≥3 months. 11) Female people of childbearing potential must agree to take effective contraceptive measures and must not undergo egg donation or egg retrieval for their own use from screening...
- 12) people must provide tumor samples. 13) people who are capable of and willing to comply with the visits and procedures stipulated in the study protocol.
- 1) people with a treatment history with drugs targeting Napi2b. 2) people with a history of intolerance to topoisomerase I inhibitors or ADC therapy.
- 3) people who are participating in another clinical study, with the exception an of observational (non-treatment) clinical study or the follow-up period of an treatment study.
- 4) people with an insufficient washout period from the previous anti-tumor therapy to the first dose.
- 5) people who received radiotherapy, including palliative stereotactic radiotherapy on the abdomen, within 4 weeks prior to the first dose.
- 6) people who received major surgery within 4 weeks prior to the first dose or those who plan to receive major surgery during the study.
- 7) people who received allogeneic bone marrow transplantation or solid organ transplantation.
- 8) people who received systemic steroids or other immunosuppressive treatment within 2 weeks prior to the first dose of the investigational drug.
- 9) people who received any live vaccine within 4 weeks prior to the first dose or those who plan to receive live vaccines during the study.
- 10) people with a medical history of leptomeningeal carcinoma or cancerous meningitis.
- 11) people with brain metastasis or spinal cord compression. 12) people with uncontrolled or clinically significant cardiovascular and cerebrovascular diseases.
- 13) people who were diagnosed with Gilbert's syndrome. 14) people with significantly symptomatic or unstable effusion in the third space requiring repeated drainage.
- 15) people with medical history of gastrointestinal perforation and/or fistula within 6 months prior to the first dose, or active gastric ulcers, duodenal ulcer, colitis ulcerative, or other gastrointestinal disorders...
- 16) people with serious infection (Grade ≥3 as per NCI CTCAE v5.0) prior to the first dose.
- 17) people with human immunodeficiency virus (HIV), active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection; people with positive syphilis antibody and a positive titer result.
- 18) people with unresolved toxicity caused by previous anti-tumor therapy. 20) people with a history of serious allergic reactions to drugs, inactive ingredients in drug products, or other monoclonal antibodies.
- 21) Female people who are pregnant as confirmed by a pregnancy test within 3 days prior to the first dose, or lactating women.
- 22) people who have any diseases, medical conditions, organ system dysfunction, or social conditions.
- 23) people with multiple primary malignancies within 5 years prior to the signing of the ICF, except for fully resected non-melanoma skin cancer, radically treated carcinoma in situ, or other radically treated solid...
The study team makes the final eligibility decision.
Where it's taking place
- Denver, Colorado, United States
- New Haven, Connecticut, United States
- Lake Mary, Florida, United States
- Louisville, Kentucky, United States
- St Louis, Missouri, United States
- Las Vegas, Nevada, United States
- Albuquerque, New Mexico, United States
- Oklahoma City, Oklahoma, United States
- Portland, Oregon, United States
- Nashville, Texas, United States
- Seattle, Washington, United States
- Fuzhou, Fujian, China
- Guangzhou, Guangdong, China
- Nanning, Guangxi, China
- Haikou, Hainan, China
- Shijiazhuang, Hebei, China
- Harbin, Heilongjiang, China
- Anyang, Henan, China
- Zhengzhou, Henan, China
- Jingzhou, Hubei, China
+ 14 more site(s).
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 and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Denver, Colorado, United States; New Haven, Connecticut, United States; Lake Mary, Florida, United States; Louisville, Kentucky, United States; St Louis, Missouri, United States; Las Vegas, Nevada, United States and 28 more location(s). 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.