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New treatment option for NSCLC
Official title A Study of YL202 in Selected Patients With Advanced Solid Tumors
ClinicalTrials.gov ID: NCT06107686
What this study is testing
What is YL202 should be intravenously infused?
YL202 should be intravenously infused is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for nsclc.
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 II study of YL202 in China to evaluate the efficacy, safety, and PK characteristics of YL202 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 to 75
You may be able to join if
- people who are aware of relevant trial information before the start of the trial, and voluntarily sign and date on the informed consent form (ICF).
- people aged from 18-75 (inclusive) years.
- Histologically or cytologically confirmed at diagnosis of NSCLC/BC/HNSCC/other locally advanced or metastatic solid tumors including but not limited...
- At least one extracranial measurable lesion according to RECIST 1.1.
- Archived or fresh tumor tissue samples can be provided.
You likely can't join if
- With prior drug therapy targeting HER3 (including antibodies, antibody-drug conjugates [ADCs]), chimeric antigen receptor T-cell immunotherapy...
- Previously intolerant to topoisomerase I inhibitors or ADC therapy composed of topoisomerase I inhibitors.
- Are participating in another clinical study, unless it is an observational (non-treatment) clinical study or in the follow-up period of an treatment...
- The washout period from the previous anti-tumor therapy is insufficient before the first dose of the investigational product.
- Patients who have received major surgery (excluding diagnostic surgery) within 4 weeks before the first dose of the investigational product or those...
- Prior treatment with allogeneic bone marrow transplantation or solid organ transplantation.
See the full eligibility criteria
- people who are aware of relevant trial information before the start of the trial, and voluntarily sign and date on the informed consent form (ICF).
- people aged from 18-75 (inclusive) years.
- Histologically or cytologically confirmed at diagnosis of NSCLC/BC/HNSCC/other locally advanced or metastatic solid tumors including but not limited to colorectal cancer, HER2-positive gastric cancer, cervical cancer...
- At least one extracranial measurable lesion according to RECIST 1.1.
- Archived or fresh tumor tissue samples can be provided.
- With Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0 or 1.
- The function of organs and bone marrow meets the requirements within 7 days before the first dose.
- Female people of childbearing potential must agree to adopt highly effective contraceptive measures from screening throughout the study period and within at least 6 months after the last dose of the investigational...
- With expected survival ≥ 3 months.
- Be capable of and willing to comply with the visits and procedures stipulated in the study protocol.
- With prior drug therapy targeting HER3 (including antibodies, antibody-drug conjugates [ADCs]), chimeric antigen receptor T-cell immunotherapy (CAR-T), and other drugs).
- Previously intolerant to topoisomerase I inhibitors or ADC therapy composed of topoisomerase I inhibitors.
- Are participating in another clinical study, unless it is an observational (non-treatment) clinical study or in the follow-up period of an treatment study.
- The washout period from the previous anti-tumor therapy is insufficient before the first dose of the investigational product.
- Patients who have received major surgery (excluding diagnostic surgery) within 4 weeks before the first dose of the investigational product or those who are expected to receive major surgery during the study.
- Prior treatment with allogeneic bone marrow transplantation or solid organ transplantation.
- Prior treatment with systemic steroids (prednisone \> 10 mg/day or equivalent) or other immunosuppressive treatment within 2 weeks before the first dose of the investigational product.
- Patients who have received any live vaccine within 4 weeks before the first dose of the investigational product or those who plan to receive live vaccine during the study period.
- With meningeal metastasis or cancerous meningitis.
- With brain metastasis or spinal cord compression.
- Patients with uncontrolled or clinically significant cardiovascular diseases.
- Clinically significant complicated pulmonary disorders.
- Patients diagnosed with Gilbert syndrome.
- Those with uncontrolled effusion in the third space requiring repeated drainage.
- With a medical history of gastrointestinal perforation and/or fistula within 6 months before the first dose, or with active gastric and duodenal ulcers, ulcerative colitis, or other gastrointestinal diseases that may...
- With serious infection before the first dose.
- With known human immunodeficiency virus (HIV) infection.
- With active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
- With a medical history of any other primary malignancies within 5 years before the first dose of the investigational product.
- Unrelieved toxicity of previous anti-tumor therapy.
- With a history of severe hypersensitivity to inactive ingredients in the raw materials and drug product or other monoclonal antibodies.
- Lactating women, or women who are confirmed pregnant via a pregnancy test within 3 days before the first dose.
- With any diseases, medical conditions, organ system dysfunction, or social conditions that may interfere with the ability of people to sign the ICF, adversely affect the ability of people to cooperate and participate in...
The study team makes the final eligibility decision.
Where it's taking place
- Hefei, Anhui, China
- Beijing, Beijing Municipality, China
- Chongqing, Chongqing Municipality, China
- Fuzhou, Fujian, China
- Guangzhou, Guangdong, China
- Meizhou, Guangdong, China
- Shantou, Guangdong, China
- Guilin, Guangxi, China
- Nanning, Guangxi, China
- Harbin, Heilongjiang, China
- Luoyang, Henan, China
- Nanyang, Henan, China
- Xinxiang, Henan, China
- Zhengzhou, Henan, China
- Jingzhou, Hubei, China
- Wuhan, Hubei, China
- Xiangyang, Hubei, China
- Changsha, Hunan, China
- Yueyang, Hunan, China
- Suzhou, Jiangsu, China
+ 21 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 to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hefei, Anhui, China; Beijing, Beijing Municipality, China; Chongqing, Chongqing Municipality, China; Fuzhou, Fujian, China; Guangzhou, Guangdong, China; Meizhou, Guangdong, China and 35 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.