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YL201 for Solid Tumors
Phase 1
Recruiting
Research Sponsored by MediLink Therapeutics (Suzhou) Co., Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1
Pathologically confirmed diagnosis of an advanced solid tumor for which prior standard treatment had proven to be ineffective or intolerable, or no standard treatment is available
Timeline
Screening 3 weeks
Treatment Varies
Follow Up by the global end of trial date, approximately within 36 months
Awards & highlights
Study Summary
This trial is testing a new drug, YL201, to see if it is safe and effective in treating patients with advanced solid tumors. The trial will be conducted in two parts: a dose escalation part to find the maximum tolerated dose (MTD) or recommended dose (RED), followed by a dose expansion part to further study the safety and efficacy of YL201 at the MTD/RED.
Who is the study for?
This trial is for adults with advanced solid tumors that haven't responded to existing treatments or have no standard treatment options. Participants must be over 18, able to follow the study plan, and provide tumor tissue samples. They should not have active hepatitis B/C, unresolved toxicities from previous cancer therapies (except certain conditions), or any condition that could affect participation.Check my eligibility
What is being tested?
YL201 is being tested in a phase 1 trial involving two parts: dose escalation to find the maximum tolerated dose/recommended dosing, and dose expansion at these doses in selected tumor types. The goal is to determine safety and effectiveness of YL201 for patients with advanced solid tumors.See study design
What are the potential side effects?
As this is a first-in-human study for YL201, specific side effects are unknown but may include typical reactions seen with cancer drugs such as fatigue, nausea, inflammation-related symptoms, allergic reactions or blood count changes.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am fully active or can carry out light work.
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My advanced cancer has not responded to standard treatments, or there are none available.
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I agree to use effective birth control and not donate eggs or sperm during and 6 months after the study.
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I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ approximately within 36 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately within 36 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Evaluate the AEs in Part 2 as characterized by type, frequency, severity, timing, seriousness and relationship to study treatment
Evaluate the objective response rate (ORR) for patients with solid tumors other than prostate cancer in Part 2, assessed using RECIST version 1.1
Evaluate the occurrence of DLTs during the first cycle in Part 1
+1 moreSecondary outcome measures
Assess the incidence of anti-YL201 antibodies
Characterize the PK parameter AUC
Characterize the PK parameter CL
+15 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Dose expansionExperimental Treatment1 Intervention
All participants enrolled in the dose expansion part
Group II: Dose escalationExperimental Treatment1 Intervention
All participants enrolled in the dose escalation part
Find a Location
Who is running the clinical trial?
MediLink Therapeutics (Suzhou) Co., Ltd.Lead Sponsor
4 Previous Clinical Trials
1,020 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My brain or spinal cord cancer is stable without needing steroids or seizure medicine.I need frequent procedures to remove excess body fluid.I have been diagnosed with Gilbert's syndrome.I am fully active or can carry out light work.My advanced cancer has not responded to standard treatments, or there are none available.I haven't had cancer treatments like chemotherapy or immunotherapy recently.I have a serious lung condition besides my cancer.I have not received a live vaccine recently and do not plan to during the study.I had a bad reaction to a specific cancer treatment (like topotecan).I have an active hepatitis B or C infection.I still have side effects from past cancer treatments.I haven't taken steroids or immunosuppressants recently, with some exceptions.I have a history of cancer spreading to the lining of my brain and spinal cord.I have not had major surgery recently and do not expect any during the study.I have heart problems that are not well-managed.I do not have active stomach ulcers or conditions that could cause internal bleeding.I agree to use effective birth control and not donate eggs or sperm during and 6 months after the study.I have at least one tumor that can be measured for treatment response.I have or might have lung inflammation not caused by an infection.I have had a stem cell transplant before starting the study drug.I have had other cancers, but they were either removed, treated on the spot, or cured.I do not have an ongoing infection needing treatment.I have had radiation therapy recently.I have at least one tumor that can be measured or have prostate cancer with only bone involvement.I am willing to provide samples of my tumor for the study.I am HIV positive.My organs and bone marrow are working well.I am 18 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: Dose escalation
- Group 2: Dose expansion
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has YL201 attained regulatory clearance from the FDA?
"The safety of YL201 was conservatively estimated to be a 1 due to its position in the preclinical stage where there is only limited information available on safety and efficacy."
Answered by AI
Are there still slots available to join this experiment?
"The information posted on clinicaltrials.gov specifies that this experiment is currently open for enrollment. It was originally advertised in June of 2022, and the details were last revised November 3rd of the same year."
Answered by AI
What is the current patient count for this research endeavor?
"Affirmative. The records available on clinicaltrials.gov reveal that this investigation, initially posted on June 9th 2022, is actively searching for participants. At the moment 196 patients are needed from 3 different medical facilities."
Answered by AI
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