What this study is
This is a multicenter, open-label, Phase 1 study. The study will enroll subjects with advanced solid tumors. It consists of six parts. Objectives for Dose-Escalation Parts (Part 1 and Part 4) To evaluate the safety and tolerability of YL211 as monotherapy in patients with selected advanced solid tumors (Part 1) and in combination with pembrolizumab in patients with second or third line locally advanced unresectable or metastatic non-squamous non-small cell lung cancer (NSCLC) (Part 4) To determine the maximum tolerated dose (MTD) and select the recommended expansion dose(s) (RED(s)) of YL211 as monotherapy in patients with advanced solid tumors (Part 1) and in combination with pembrolizumab in patients with second line locally advanced unresectable or metastatic non-squamous NSCLC (Part 4) Objectives for Backfill Enrollment Parts (Part 2 and Part 5) To better estimate and characterize the safety and efficacy of YL211 as monotherapy in patients with metastatic colorectal cancer (mCRC) or locally advanced unresectable or metastatic NSCLC (Part 2) and in combination with pembrolizumab in patients with previously untreated locally advanced unresectable or metastatic non-squamous NSCLC (Part 5) To select the RED(s) of YL211 as monotherapy in patients with metastatic colorectal cancer (mCRC) or locally advanced unresectable or metastatic NSCLC (Part 2) and in combination with pembrolizumab in patients with previously untreated locally advanced unresectable or metastatic non-squamous NSCLC (Part 5) Objectives for the Dose-Expansion Parts (Part 3 and Part 6) To further characterize the safety and efficacy of YL211 as monotherapy (Part 3) in patients with locally advanced unresectable or metastatic non-squamous or squamous NSCLC and in combination with pembrolizumab in patients with previously untreated locally advanced unresectable or metastatic non- squamous NSCLC (Part 6) To compare the clinical activity of YL211 in combination with pembrolizumab against pembrolizumab, pemetrexed, and platinum-based chemotherapy (cisplatin or carboplatin) in participants with previously untreated advanced unresectable or metastatic non-squamous NSCLC (Part 6)
What's being tested
- YL211
Intervention · DRUG
Patients will be treated with YL211 intravenous (IV) infusion only.
- YL211+Pembrolizumab
Intervention · DRUG
Patients will be treated with YL211 and Pembro by infusion.
- YL211 + Pembro or Pembro+ Pemetrexed + (Carboplatin or Cisplatin)
Intervention · DRUG
participants will receive therapy YL211 + Pembro or Pembro+ Pemetrexed + (Carboplatin or Cisplatin) by infusion.(Part 6)
Study details
- Official title
- A Phase 1, Multicenter, Open-Label, First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of YL211 in Patients With Advanced Solid Tumors
- Sponsor
- MediLink Therapeutics (Suzhou) Co., Ltd.
- Conditions
- Advanced Solid Tumors
- Enrolling
- 500 people
- Starts
- 2024-05-01
- Est. completion
- 2031-06-30
- Design
- Open-label, non-randomized, parallel groups, Phase 1
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- Informed of the trial before the start of the trial and voluntarily sign their name and date on the ICF.
- Aged ≥18 years.
- Be able and willing to comply with protocol visits and procedures.
- Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or; 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
You can't join if
- 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.
- Previously received an ADC consisting of a TopoI
- 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).
- A history of leptomeningeal carcinomatosis or carcinomatous meningitis
- 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
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
Loading treatment details…
Study locations (21)
21 openUniversity of Colorado Hospital - Anschutz Cancer Pavilion
Aurora, Colorado, United States
- Ashley Fisher · ContactASHLEY.R.FISHER@CUANSCHUTZ.EDU
- Antonio Jimeno · Principal investigator
RecruitingSarah Cannon Research Institute (SCRI) at HealthONE
Denver, Colorado, United States
- Jason Henry · ContactJason.Henry2@sarahcannon.com
- Jason Henry · Principal investigator
RecruitingYale School of Medicine - Yale Cancer Center - Smilow Cancer Hospital Care Centers - North Haven
North Haven, Connecticut, United States
- Anastasio Gabrielle · Contactgabrielle.anastasio@yale.edu
- Michael Cecchini · Principal investigator
RecruitingSarah Cannon Research Institute at Florida Cancer Specialists
Orlando, Florida, United States
- Elizabeth Gilmore · ContactElizabeth.Griffith@scri.com
- Cesar Perez · Principal investigator
RecruitingFlorida Cancer Specialists & Research Institute (FCS) - Sarasota Cattlemen Office
Sarasota, Florida, United States
- Carly Taylor · Contactctaylor@flcancer.com
- Manish Patel · Principal investigator
RecruitingComprehensive Cancer Centers of Nevada (CCCN) - Central Valley
Las Vegas, Nevada, United States
- site coordinator · Contact
RecruitingUniversity of Cincinnati Vontz Center for Molecular Studies
Cincinnati, Ohio, United States
- site coordinator · Contact
RecruitingThe University of Texas - MD Anderson Cancer Center
Houston, Texas, United States
- Coordinator Clinical operation director · ContactRA@medilinkthera.com
RecruitingNEXT Oncology - Houston
Houston, Texas, United States
- site coordinator · Contact
RecruitingNEXT Oncology - Dallas
Irving, Texas, United States
- Erica Torres · Contactetorres@nextoncology.com
- Shiraj Sen · Principal investigator
RecruitingNEXT San Antonio
San Antonio, Texas, United States
- Coordinator Clinical operation director · ContactRA@medilinkthera.com
Recruiting
10 sites outside the US
Gosford Hospital
Gosford, New South Wales, Australia
- site coordinator · Contact
RecruitingOne Clinical Research - Nedlands
Nedlands, Western Australia, Australia
- site coordinator · Contact
RecruitingMonash Health
Melbourne, Australia
- Sophia Frentzas · Contactsophia.frentzas@monash.edu
- Sophia Frentzas · Principal investigator
RecruitingPrincess Margaret Hospital
Toronto, Toronto, Canada
- Albiruni Razak · ContactAlbiruni.razak@uhn.ca
- Albiruni Razak · Principal investigator
RecruitingThe Ottawa Hospital - General Campus
Ottawa, Canada
- Jura Nakamura · Contactjunakamura@ohri.ca
- Scott Laurie · Principal investigator
RecruitingChina-Japan Friendship Hospital
Beijing, Beijing Municipality, China
- site coordinator · Contact
RecruitingThe First Affiliated Hospital - Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
- site coordinator · Contact
RecruitingWenzhou Medical University - The First Affiliated Hospital
Wenzhou, Zhejiang, China
- site coordinator · Contact
RecruitingWest China Hospital, Sichuan University
Chengdu, China
- Yan Zhang · Contact18980601166@qq.com
- Yan Zhang · Principal investigator
RecruitingSun Yat-sen University Cancer Center
Guangzhou, China
- Danyun Ruan · Contactruandy1@sysucc.org.cn
- Ruihua Xu · Principal investigator
- Danyun Ruan · Sub-investigator
Recruiting
Study team
Sponsor
MediLink Therapeutics (Suzhou) Co., Ltd.
Study ID YL211-INT-101-01
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.