YL205 for Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called YL205, a potential drug, to determine its safety and effectiveness for people with advanced solid tumors, including hard-to-treat cancers like ovarian and lung cancer. YL205 is administered through an IV every three weeks, and the trial will assess how the body handles different doses. Suitable participants have a confirmed diagnosis of these cancers and have not previously tried similar treatments. They must have at least one visible, measurable tumor. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. However, there is a requirement for a sufficient washout period (time without taking certain medications) from previous anti-tumor therapy before starting the trial.
Is there any evidence suggesting that YL205 is likely to be safe for humans?
Research has shown that YL205 underwent early testing to assess its safety for humans. In these studies, researchers examined how well participants tolerated the drug and identified any side effects. Although detailed results from these early trials are unavailable, the drug's progression to both Phase 1 and Phase 2 trials suggests it demonstrated some level of safety in initial tests.
Phase 1 trials primarily focus on safety, involving a small group of participants to determine a safe dose. A drug's advancement to Phase 2 likely indicates it was deemed safe enough in Phase 1 for further testing. This progression suggests that YL205 is expected to be well-tolerated, though specific information on side effects from these studies remains unclear.
Joining a clinical trial always involves some risk, but the trial's advancement to Phase 2 is a positive sign regarding safety. Prospective participants should consult healthcare providers to understand the risks and benefits before joining any study.12345Why do researchers think this study treatment might be promising?
YL205 is unique because it is a new treatment for advanced solid tumors that is administered intravenously as a lyophilized powder every three weeks. Unlike standard chemotherapy options that often target rapidly dividing cells in general, YL205 may offer a more targeted approach, potentially reducing side effects and improving effectiveness. Researchers are excited about YL205 because it is being explored across multiple phases to determine the best dose and further understand its impact on cancer growth, which could lead to more personalized and effective cancer treatments.
What evidence suggests that YL205 might be an effective treatment for advanced solid tumors?
Research has shown that YL205 targets a protein called NaPi2b, often found in high amounts in certain solid tumors. Early lab studies demonstrated that YL205 can stop tumors from growing by blocking this protein. This trial will evaluate YL205's effectiveness against advanced solid tumors by directly attacking the cancer cells. Although these initial lab results are promising, more studies with people are needed to confirm its effectiveness.12367
Are You a Good Fit for This Trial?
This trial is for adults with advanced solid tumors, including ovarian cancer, non-squamous non-small cell lung cancer, renal cell carcinoma, endometrial cancer or other Napi2b-overexpressing tumors. Participants must have a positive Napi2b test and at least one measurable lesion. They should expect to live more than 3 months and agree to use effective contraception. Tumor samples are required for participation.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Phase Ia: Dose Escalation
Participants with advanced solid tumors receive YL205 intravenously every 3 weeks at several dose levels
Phase Ib: Dose Expansion
Participants receive YL205 intravenously every 3 weeks at no less than two dose levels
Phase II: Cohort Expansion
Participants receive YL205 intravenously every 3 weeks at the recommended phase 2 dose (RP2D)
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- YL205
Trial Overview
The study is testing YL205 administered through IV infusion in patients from China with advanced solid tumors. It aims to assess the safety, tolerability, how the body processes the drug (pharmacokinetics), and its initial effectiveness against these cancers.
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
YL205 is provided as the lyophilized powder, 160 mg/vial. Adcanced solid tumors patients will be given YL205 by intravenously once every 3 weeks (Q3W) as a cycle at no less than two dose levels.
YL205 is provided as the lyophilized powder, 160 mg/vial. Adcanced solid tumors patients will be given YL205 by intravenously once every 3 weeks (Q3W) as a cycle at several dose levels.
YL205 is provided as the lyophilized powder, 160 mg/vial. Adcanced solid tumors patients will be given YL205 by intravenously once every 3 weeks (Q3W) as a cycle at RP2D.
Find a Clinic Near You
Who Is Running the Clinical Trial?
MediLink Therapeutics (Suzhou) Co., Ltd.
Lead Sponsor
Citations
A Clinical Study of YL205 in Patients With Advanced Solid ...
This study is a multicenter, open-label, phase I/II study of YL205 in China to evaluate the safety, tolerability, PK characteristics and preliminary ...
2.
aacrjournals.org
aacrjournals.org/cancerres/article/84/6_Supplement/1894/736333/Abstract-1894-Preclinical-development-of-YL205-aPreclinical development of YL205, a novel NaPi2b-targeting ...
This study evaluated the drug properties, efficacy, safety and pharmacokinetic profiles of YL205 in nonclinical studies.
Chinese Clinical Trial Register (ChiCTR)
... YL205; • To preliminarily evaluate the efficacy of YL205 in patients with advanced solid tumors. Phase Ib: Dose expansion phase Primary ...
Phase 1 clinical trials update - Norton Healthcare Provider
... Efficacy of YL205 in Patients With Advanced Solid Tumors. Study Type: Drug Study. Sponsor: MediLink Therapeutics (Suzhou) Co., Ltd. Phase I/II.
A Clinical Study of YL205 in Patients With Advanced Solid ...
Outcome Measure, Measure Description, Time Frame. To evalue the DLTs, Approximately within 36 months. To evalue the TEAEs, Treatment Emergent Adverse Event ...
6.
nortonhealthcare.com
nortonhealthcare.com/services-and-conditions/cancer-care/services/current-cancer-clinical-trials/early-phase/Norton Cancer Institute Early Phase Trials Program
... Safety, Tolerability, Pharmacokinetic Characteristics and Preliminary Efficacy of YL205 in Patients With Advanced Solid Tumors. Study Type: Drug Study.
7.
medicine.yale.edu
medicine.yale.edu/ycci/clinicaltrials/trial/a-phase-i-ii-study-of-yl205-in-patients-with-advanced-solid-tumors/A Multi-center, Open-label, Phase I/II Clinical Study to ...
This study is a multicenter, open-label, phase I/II study of YL205 in China to evaluate the safety, tolerability, PK characteristics and ...
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