Study of YL201 for Patients with Advanced Solid Tumors

Sponsor: MediLink Therapeutics (Suzhou) Co., Ltd.

Sponsor score: 0

ClinicalTrials ID:NCT05434234

This clinical trial is testing a new drug, YL201, to see if it is safe and effective for treating advanced solid tumors in adults. The study is being conducted in China and the United States and involves two parts: finding the right dose and then testing it on specific tumor types.

Patient Parameters

Program Overview

This study is exploring a new treatment called YL201 for adults with advanced solid tumors that have not responded to other treatments or for which no standard treatment is available. The study has two parts: the first part aims to find the best dose of YL201, and the second part will test this dose on specific types of advanced solid tumors to better understand its safety and effectiveness.

Eligibility Criteria

Inclusion Criteria

  • Must be informed about the trial and voluntarily agree to participate.
  • Must be 18 years or older.
  • Must be in good general health, able to perform daily activities with minimal restrictions.
  • Must have good organ and bone marrow function.
  • Women who can become pregnant must use effective birth control and not donate eggs during the study and for a specified time after the last dose. Men must use effective birth control and not donate sperm during the study and for a specified time after the last dose.
  • Must have a life expectancy of at least 3 months.
  • Must be willing to attend all study visits and follow procedures.
  • Must have at least one tumor that can be measured by scans.
  • Must have a confirmed diagnosis of an advanced solid tumor, such as small cell lung cancer, prostate cancer, esophageal cancer, or non-small cell lung cancer, that has not responded to standard treatments or for which no standard treatment is available. For certain patients, no prior cancer treatment is allowed.

Exclusion Criteria

  • Cannot be enrolled in another clinical study unless it is non-interventional or during the follow-up period of an interventional study.
  • Cannot have received certain cancer treatments, including chemotherapy or targeted therapy, within a specified time before starting the study drug.
  • Cannot have had major surgery recently or expect to have major surgery during the study.
  • Cannot have had certain types of stem cell transplants recently.
  • Cannot be taking high doses of steroids or other immune-suppressing drugs recently.
  • Cannot have received a live vaccine recently or plan to receive one during the study.
  • Cannot have active HIV, hepatitis B, or hepatitis C infections.
  • Cannot have unresolved side effects from previous cancer treatments, unless they are mild and well-managed.
  • Cannot have severe allergies to the study drug or its ingredients.
  • Cannot be pregnant or breastfeeding.

Locations

FACILITYZIPCITYSTATE
00295628Fair OaksCalifornia
00192093-0698La JollaCalifornia
00380124Lone TreeColorado
00420007Washington D.C.District of Columbia
00502114BostonMassachusetts
00648109Ann ArborMichigan
00748292DetroitMichigan
00863110St LouisMissouri
00987505-699Santa FeNew Mexico
01010029New YorkNew York

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.