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New treatment option for Non Small Cell Lung Cancer
Official title A Study of YL202 in Patients With Advanced Solid Tumors
ClinicalTrials.gov ID: NCT07202364
What this study is testing
What is YL202?
YL202 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for non small cell lung cancer.
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 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
- people must meet all the following criteria to be included in the study:
- people who are aware of relevant study information prior to the start of the study, and voluntarily sign and date on the informed consent form (ICF).
- people aged ≥18 years at the time of giving informed consent
- Body mass index (BMI) within the range of 18 to 32 kg/m2.
- people with histologically or cytologically confirmed non-Sq NSCLC/CRC/CC or other advanced solid tumor, and had received 1-2 lines of systemic...
You likely can't join if
- people who meet any of the following criteria should be excluded from the study:
- Prior drug therapy targeting HER3
- 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 prior to the first dose of the investigational product.
- Patients who received major surgery (excluding diagnostic surgery) within 4 weeks prior to the first dose of the investigational product or those who...
See the full eligibility criteria
Who can join
- people must meet all the following criteria to be included in the study:
- people who are aware of relevant study information prior to the start of the study, and voluntarily sign and date on the informed consent form (ICF).
- people aged ≥18 years at the time of giving informed consent
- Body mass index (BMI) within the range of 18 to 32 kg/m2.
- people with histologically or cytologically confirmed non-Sq NSCLC/CRC/CC or other advanced solid tumor, and had received 1-2 lines of systemic therapy in the advanced/metastatic setting
- There is at least one extracranial measurable lesion as the target lesion per the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
- Archived or fresh tumor tissue samples are available.
- 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 prior to 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...
- Expected survival ≥3 months.
- Be capable of and willing to comply with the visits and procedures stipulated in the study protocol.
What rules you out
- people who meet any of the following criteria should be excluded from the study:
- Prior drug therapy targeting HER3
- 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 prior to the first dose of the investigational product.
- Patients who received major surgery (excluding diagnostic surgery) within 4 weeks prior to 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 prior to the first dose of the investigational product.
- Patients who received any live vaccine within 4 weeks prior to the first dose of the investigational product or those who plan to receive live vaccine during the study period.
- Meningeal metastasis or cancerous meningitis.
- Brain metastasis or spinal cord compression.
- Patients with uncontrolled or clinically significant cardiovascular diseases.
- Clinically significant complicated pulmonary disorders.
- Medical history of hepatic encephalopathy within 6 months prior to the first dose.
- people with active or chronic corneal disorders, or other active eye disorders requiring continuous treatment, or any clinically significant corneal disorders that preclude adequate monitoring of drug-induced...
- Diagnosed with Gilbert's syndrome.
- Significantly symptomatic or unstable pleural effusion, peritoneal effusion, and pericardial effusion, or those requiring repeated drainage.
- Medical history of gastrointestinal perforation and/or fistula within 6 months prior to the first dose, or active gastric and duodenal ulcers, ulcerative colitis, or other gastrointestinal diseases that may cause...
- Serious infection prior to the first dose (National Cancer Institute-Common Terminology Criteria for Adverse Events [NCI CTCAE] v5.0 grade ≥3),
- Patients with severe coagulopathy or other diseases with evident risk of bleeding.
- Patients with uncontrolled diabetes mellitus.
- Human immunodeficiency virus (HIV) infection; positive syphilis antibody and a positive titer result.
- Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
- Medical history of any other primary malignancies within 5 years prior to the first dose of the investigational product, except fully resected non-melanoma skin cancer, cured in-situ disease, or other cured solid tumors.
- Unresolved toxicity of previous anti-tumor therapy,
- History of severe hypersensitivity to inactive ingredients in the drug substance (DS) and drug product (DP) or other monoclonal antibodies.
- Lactating women, or women who are confirmed pregnant via a pregnancy test within 3 days prior to the first dose.
- Have any diseases, medical conditions, organ system dysfunction, or social conditions that may interfere with the subject ability to sign the ICF, adversely affect the subject ability to cooperate and participate in the...
The study team makes the final eligibility decision.
Where it's taking place
- Changsha, Hunan, 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 and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Changsha, Hunan, 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.