Evaluating YL211 for patients with advanced solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter, open-label Phase 1 study aims to assess the safety, tolerability, pharmacokinetics, and efficacy of YL211 in patients with advanced solid tumors. The study is divided into three parts: the first part focuses on dose escalation to determine the maximum tolerated dose (MTD) and recommended dose (RED), the second part involves backfill enrollment to further evaluate safety and efficacy, and the third part is a dose-expansion phase to confirm findings at the MTD/RED. YL211 will be administered intravenously until treatment discontinuation criteria are met.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Informed of the trial before the start of the trial and voluntarily sign their name and date on the ICF.
2. Aged ≥18 years.
3. Be able and willing to comply with protocol visits and procedures.
4. Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or
5. Adequate organ and bone marrow function.

For Part 1: History of an advanced solid tumors (including locally advanced unresectable or metastatic NSCLC, metastatic colorectal carcinoma (mCRC), advanced gastric adenocarcinoma (GAC)/ gastroesophageal junction adenocarcinoma (GEJA), pancreatic ductal adenocarcinoma (PDAC), hepatocellular carcinoma (HCC), intrahepatic biliary tract cancer (ih-BTC), and head and neck squamous cell carcinoma (HNSCC) who failed currently available standard therapies and are not amenable to surgical resection, or for whom no available standard therapy or no other approved therapeutic options that have demonstrated clinical benefit.

For Part 2: For patients with CRC: History of histologically or cytologically confirmed diagnosis of metastatic CRC and at least 2 prior regimens of standard treatment For patients with NSCLC: History of histologically or cytologically confirmed diagnosis of locally advanced unresectable or metastatic NSCLC and no more than 2 lines of prior cytotoxic systemic therapy in the locally advanced or metastatic setting.

For Part 3: History of histologically or cytologically confirmed diagnosis of locally advanced unresectable or metastatic non-squamous (Part 3A) or squamous (Part 3B) NSCLC and no more than 2 lines of prior systemic therapy

For Part 4: History of histologically or cytologically confirmed diagnosis of locally advanced unresectable or metastatic non-squamous NSCLC who have progressed on or after 1 or 2 prior lines of systemic therapy

For Part 5 and Part 6 Histologically or cytologically documented locally advanced unresectable or metastatic non-squamous NSCLC that is not eligible for curative surgery and/or definitive chemoradiotherapy and no prior systemic treatment for advanced unresectable or metastatic NSCLC

Exclusion Criteria:

1. Prior treatment with an agent targeting c-MET (including antibody, ADC, chimeric antigen receptor T cell \[CAR-T\], and other drugs) with the exception of prior treatment with MET-targeted TKIs which are allowed.
2. Previously received an ADC consisting of a TopoI
3. Received continuous systemic steroids therapy for more than 28 days or require long-term (≥ 28 days) use of systemic steroids therapy within 28 days before the first administration, or have other acquired or congenital immune deficiency diseases. (Note: The protocol lists specific situational exceptions immediately following this clause).
4. A history of leptomeningeal carcinomatosis or carcinomatous meningitis
5. Brain metastasis, except for the following situations:

   Participants with asymptomatic brain metastasis who do not require immediate local or systemic treatment (such as mannitol or steroids, surgery, or radiotherapy) are allowed to be enrolled If the participant's brain metastasis is treated and the condition of the metastasis is stable (brain imaging examination at least 2 weeks before the first administration shows that the lesion is stable, there is no evidence of new or original brain metastasis enlargement, there are no new neurological symptoms, and immediate local or systemic treatment is not required), admission is allowed
6. Clinically significant concomitant pulmonary disease, including but not limited to:

A history of drug-induced pneumonitis A history of (non-infectious) interstitial lung disease (ILD)/pneumonitis that requires steroids, current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening

Where it's running

• University of Colorado Hospital - Anschutz Cancer Pavilion
  Aurora, Colorado, United States Recruiting
• Sarah Cannon Research Institute (SCRI) at HealthONE
  Denver, Colorado, United States Recruiting
• Yale School of Medicine - Yale Cancer Center - Smilow Cancer Hospital Care Centers - North Haven
  North Haven, Connecticut, United States Recruiting
• Sarah Cannon Research Institute at Florida Cancer Specialists
  Orlando, Florida, United States Recruiting
• Florida Cancer Specialists & Research Institute (FCS) - Sarasota Cattlemen Office
  Sarasota, Florida, United States Recruiting
• Comprehensive Cancer Centers of Nevada (CCCN) - Central Valley
  Las Vegas, Nevada, United States Recruiting

Study contacts

• Study coordinator: MediLink Study Team
• Email: clinicaltrials@medilinkthera.com
• Phone: +86 0512-62858368

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.