A Study of YL201 in Patients With Advanced Solid Tumors

Launched by MEDILINK THERAPEUTICS (SUZHOU) CO., LTD. · Jun 22, 2022

Keywords

ClinConnect Summary

This clinical trial is investigating a new treatment called YL201 for patients with advanced solid tumors, which are types of cancer that have spread and are not responding to existing therapies. The study is taking place in various locations in China and the United States and has two parts. In the first part, researchers will gradually increase the dose of YL201 to find the highest amount that can be safely given to patients. The second part will focus on specific types of tumors to learn more about how safe and effective YL201 is at that dose.

To participate in this trial, patients must be at least 18 years old and have a confirmed diagnosis of an advanced solid tumor that hasn't responded to standard treatments. They should also be in relatively good health, meaning they can carry out daily activities and have a life expectancy of at least three months. Participants will be closely monitored throughout the study and may need to provide tissue samples from their tumors. It's important to note that patients who are pregnant, breastfeeding, or have certain health conditions may not be eligible. This trial aims to gather important information that could help improve treatment options for patients with advanced cancer in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Informed of the trial before the start of the trial and voluntarily sign their name and date on the ICF
• • Aged ≥18 years
• • Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1
• • Adequate organ and bone marrow function
• • 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 5 months after the last dose of atezolizumab or 6 months after the last dose of YL201, whichever is later. 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 YL201.
• • Life expectancy of ≥3 months
• • Able and willing to comply with protocol visits and procedures
• • Have at least 1 evaluable tumor lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
• • Pathologically confirmed diagnosis of an advanced solid tumor (SCLC, mCRPC, ESCC and NSCLC are preferred) for which standard treatment had proven to be ineffective or intolerable, or no standard treatment is available. For ES-SCLC patients in Arm C: no prior anti-cancer treatment
• Exclusion Criteria:
• • Concurrent enrollment in another clinical study, unless it is an observational (noninterventional) clinical study or during the follow-up period of an interventional study
• • Prior systemic anticancer treatment including chemotherapy, molecular -targeted therapy, hormonal therapy, immunotherapy, or biological therapy within 3 weeks before the first dose of study drug (use of oral fluorouracil \[eg, tegafur and capecitabine\] or small molecular-targeted therapy within 2 weeks or 5 half-life periods \[whichever is shorter\]before the first dose; use of mitomycin or nitrosoureas within 6 weeks before the first dose; use of herbal medicine with antitumor indications or nonspecific immunomodulators \[eg, thymosin, interferon, and interleukin\] within 2 weeks before the first dose).
• • Prior radiation therapy, including palliative stereotactic radiation with abdominal, within 4 weeks before the first dose of study drug (if palliative stereotactic radiation therapy without abdominal, within 2 weeks)
• • Undergone major surgery (not including diagnostic surgery) within 4 weeks before the first dose of study drug or expect major surgery during the study
• • Undergone allogeneic hematopoietic stem cell transplantation (HSCT) before the first dose of study drug, or autologous HSCT within 3 months before the first dose of study drug
• • Received systemic steroids (\>10 mg/day of prednisone or its equivalent) or other immunosuppressive therapy within 2 weeks before the first dose of study drug. Received any live vaccine within 4 weeks before the first dose of study drug or intend to receive a live vaccine during the study
• • Known human immunodeficiency virus (HIV) infection
• • Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection. Active HBV is defined as hepatitis B core antibody (HBcAb) or hepatitis B surface antigen (HBsAg) positive, and HBV DNA level above ULN at the study site; active HCV is defined as positive hepatitis C antibody and HCV RNA level above ULN at the study site
• • Unresolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia and pigmentation) not yet resolved to NCI CTCAE Grade ≤1, baseline, or the level specified in the inclusion/exclusion criteria. Patients with chronic Grade 2 toxicities who are asymptomatic or adequately managed with stable medication may be enrolled after discussion with the sponsor
• • A history of severe hypersensitivity reactions to the drug substances, inactive ingredients in the drug product, or other mAbs
• • Women who are breastfeeding or pregnant as confirmed by pregnancy tests performed within 7 days before the first dose