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New treatment option for Advanced Solid Tumor
Official title A Phase I/II Study of HY05350 in Mesothelin(MSLN)-Positive Advanced Solid Tumors
ClinicalTrials.gov ID: NCT07083323
What this study is testing
What is HY05350 for injection?
HY05350 for injection is an investigational medicine, given as an once-weekly infusion into a vein, being studied as a potential treatment for advanced solid tumor.
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 is a multicenter, open-label Phase I/II clinical study to evaluate the safety, tolerability, pharmacokinetic characteristics and preliminary clinical efficacy of HY05350 for injection in patients with MSLN-positive 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. Healthy volunteers may be eligible.
You may be able to join if
- Aged ≥18 years and ≤75 years at the time of signing the informed consent form, regardless of gender.
- Investigator-assessed expected survival period ≥3 months.
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1.
- Patients with cytologically or pathologically confirmed advanced solid tumors who have failed standard treatment.
- people enrolled in the dose escalation stage must have evaluable tumor lesions, and people enrolled in the dose expansion stage must have at least...
You likely can't join if
- Received radiotherapy, chemotherapy, endocrine therapy, biological therapy, immunotherapy and other anti-tumor therapies within 4 weeks before the...
- Received other investigational drugs or participated in treatment medical device studies within 4 weeks before the first drug administration.
- Had received or planned to receive live/attenuated vaccines or mRNA vaccines within 4 weeks before screening.
- Pregnant or lactating women.
- people with adverse events caused by previous anti-tumor therapy that remained \> Grade 1 (based on CTCAE 5.0) before the first drug administration.
- people with a history of ≥ Grade 3 immune-related adverse events or who discontinued immunotherapy due to irAE of any grade.
See the full eligibility criteria
- Aged ≥18 years and ≤75 years at the time of signing the informed consent form, regardless of gender.
- Investigator-assessed expected survival period ≥3 months.
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1.
- Patients with cytologically or pathologically confirmed advanced solid tumors who have failed standard treatment.
- people enrolled in the dose escalation stage must have evaluable tumor lesions, and people enrolled in the dose expansion stage must have at least one measurable tumor lesion (based on RECIST 1.1).
- Participant must have adequate main organ function.
- Agree to provide archived pathological tissues or fresh biopsy tumor tissues for detection of related markers such as MSLN and Programmed cell death ligand 1 (PD-L1) expression levels, and MSLN expression is positive.
- Female people of childbearing potential must have a negative serum pregnancy test within 7 days before the first drug administration, and be willing to use effective contraceptive methods to prevent pregnancy and have...
- Received radiotherapy, chemotherapy, endocrine therapy, biological therapy, immunotherapy and other anti-tumor therapies within 4 weeks before the first drug administration.
- Received other investigational drugs or participated in treatment medical device studies within 4 weeks before the first drug administration.
- Had received or planned to receive live/attenuated vaccines or mRNA vaccines within 4 weeks before screening.
- Pregnant or lactating women.
- people with adverse events caused by previous anti-tumor therapy that remained \> Grade 1 (based on CTCAE 5.0) before the first drug administration.
- people with a history of ≥ Grade 3 immune-related adverse events or who discontinued immunotherapy due to irAE of any grade.
- people with primary central nervous system (CNS) tumors, symptomatic CNS metastases, meningeal metastases, or a history of epilepsy are excluded.
- people who underwent major surgery on vital organs (excluding biopsy) within 4 weeks before the first drug administration, experienced significant trauma, or require major elective surgery during the trial.
- people with a history of tissue or organ transplantation.
- people who had severe infections within 4 weeks before the first drug administration.
- Positive human immunodeficiency virus test.
- Active hepatitis B, untreated chronic hepatitis B, or chronic hepatitis B that is treated but uncontrolled.
- people with active Hepatitis C virus(HCV) infection;
- Positive treponema pallidum antibody and confirmed positive by diagnostic test;
- people with untreated or ongoing tuberculosis.
- Known severe allergic history, or known allergic reactions to macromolecular protein preparations/antibodies or any component of the investigational drug.
- History of active autoimmune diseases or a history of autoimmune diseases with potential for recurrence.
- people who received systemic glucocorticoids or other immunosuppressants within 14 days before the first drug administration.
- History of non-infectious pneumonia requiring glucocorticoid treatment or current interstitial lung disease.
- History of severe cardiovascular and cerebrovascular diseases.
- people with thrombosis or bleeding risk.
- Known history of psychoactive substance abuse or drug use that is considered to affect study compliance.
- Except for the tumor enrolled in the study, people with other active malignant tumors within 1 year before the first drug administration.
- Uncontrolled pleural effusion, pericardial effusion, or ascites requiring drainage.
- people deemed unsuitable for participation by the investigator.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, 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 to 75 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, 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.