A Study of YL202 in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer and B… (NCT05653752) | Clinical Trial Compass
Active — Not RecruitingPhase 1
A Study of YL202 in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer and Breast Cancer
United States, China80 participantsStarted 2022-12-20
Plain-language summary
This is a phase 1, multicenter, open-label, first-in-human study of YL202 conducted in the United States and China.
The study will evaluate the safety and tolerability of YL202 in patients with locally advanced or metastatic epidermal growth factor receptor (EGFR)-mutated NSCLC or hormone receptor (HR)-positive and HER2-negative BC, which have been heavily treated by standard treatment.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Informed of the trial before the start of the trial and voluntarily sign their name and date on the informed consent form
. Aged ≥18 years
. Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 to 2
. Adequate organ and bone marrow function, defined as follows:
. Female patients of childbearing potential must agree to use a highly effective form of contraception and not donate, or retrieve for their own use, ova from the time of screening and throughout the study period, and for at least 6 months after the last dose of study drug. Male patients must agree to use a highly effective form of contraception and not freeze or donate sperm from the time of screening and throughout the study period, and for at least 6 months after the last dose of study drug.
. Life expectancy of ≥3 months
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Evaluate the occurrence of DLTs during the first cycle
Timeframe: At the end of Cycle 1 (each cycle is 21 days)
2
Evaluate the AEs as characterized by type, frequency, severity, timing, seriousness and relationship to study treatment
Timeframe: By the global end of trial date, approximately within 36 months
. Able and willing to comply with protocol visits and procedures
. For NSCLC patients:
Exclusion criteria
. Prior treatment with an agent targeting HER3 (including antibody, ADC, chimeric antigen receptor T cell \[CAR-T\], and other drugs)
. Intolerant to prior treatment with a topoisomerase I inhibitor or an ADC that consists of a topoisomerase I inhibitor, including but not limited to topotecan, irinotecan, and DXd (e.g., severe diarrhea)
. Concurrent enrollment in another clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study
. Inadequate washout period for prior anticancer treatment before the first dose of study drug, defined as follows:
. Undergone major surgery (not including diagnostic surgery) within 4 weeks before the first dose of study drug or expect major surgery during the study
. Prior allogeneic bone marrow transplantation or solid-organ transplantation
. Received systemic steroids (\>20 mg/day of prednisone or its equivalent) or other immunosuppressive therapy within 2 weeks before the first dose of study drug. The following are exceptions to this criterion:
. Received any live vaccine within 4 weeks before the first dose of study drug or intend to receive a live vaccine during the study