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Advanced Solid TumorsPhase 1NCT06384352

Safety,Tolerability, Pharmacokinetics, and Efficacy of YL211 in Patients With Advanced Solid Tumors

A Phase 1 study testing YL211, YL211+Pembrolizumab and YL211 + Pembro or Pembro+ Pemetrexed + (Carboplatin or Cisplatin) in people with Advanced Solid Tumors, run by MediLink Therapeutics (Suzhou) Co., Ltd. at 21 sites in 4 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Solid Tumors
What is being tested?
YL211, YL211+Pembrolizumab and YL211 + Pembro or Pembro+ Pemetrexed + (Carboplatin or Cisplatin)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
500 participants
Where
21 sitesin 4 countries
Study dates
1 May 2024to 30 Jun 2031
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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

Who cannot join

  • 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

Trial locations and contacts

21 sites in 4 countries. Contact the study team or a site near you to ask about taking part.

MediLink Study Team contact

+86 0512-62858368

clinicaltrials@medilinkthera.com

21 sites in 4 countries

United States11 sites, 11 recruiting

  • University of Colorado Hospital - Anschutz Cancer Pavilion

    Aurora, Colorado, 80045

    Ashley Fisher, ASHLEY.R.FISHER@CUANSCHUTZ.EDU

    Antonio Jimeno

    Recruiting

  • University of Cincinnati Vontz Center for Molecular Studies

    Cincinnati, Ohio, 45219

    site coordinator

    Recruiting

  • Sarah Cannon Research Institute (SCRI) at HealthONE

    Denver, Colorado, 80218-1238

    Jason Henry, Jason.Henry2@sarahcannon.com

    Jason Henry

    Recruiting

  • The University of Texas - MD Anderson Cancer Center

    Houston, Texas, 77030

    Coordinator Clinical operation director, RA@medilinkthera.com

    Recruiting

  • NEXT Oncology - Houston

    Houston, Texas, 77055

    site coordinator

    Recruiting

  • NEXT Oncology - Dallas

    Irving, Texas, 75039

    Erica Torres, etorres@nextoncology.com

    Shiraj Sen

    Recruiting

  • Comprehensive Cancer Centers of Nevada (CCCN) - Central Valley

    Las Vegas, Nevada, 89169

    site coordinator

    Recruiting

  • Yale School of Medicine - Yale Cancer Center - Smilow Cancer Hospital Care Centers - North Haven

    North Haven, Connecticut, 06473-2142

    Anastasio Gabrielle, gabrielle.anastasio@yale.edu

    Michael Cecchini

    Recruiting

  • Sarah Cannon Research Institute at Florida Cancer Specialists

    Orlando, Florida, 32827

    Elizabeth Gilmore, Elizabeth.Griffith@scri.com

    Cesar Perez

    Recruiting

  • NEXT San Antonio

    San Antonio, Texas, 78229

    Coordinator Clinical operation director, RA@medilinkthera.com

    Recruiting

  • Florida Cancer Specialists & Research Institute (FCS) - Sarasota Cattlemen Office

    Sarasota, Florida, 34232-6422

    Carly Taylor, ctaylor@flcancer.com

    Manish Patel

    Recruiting

Other trials in United States

China5 sites, 5 recruiting

  • China-Japan Friendship Hospital

    Beijing, Beijing Municipality, 100029

    site coordinator

    Recruiting

  • West China Hospital, Sichuan University

    Chengdu

    Yan Zhang, 18980601166@qq.com

    Yan Zhang

    Recruiting

  • Sun Yat-sen University Cancer Center

    Guangzhou

    Danyun Ruan, ruandy1@sysucc.org.cn

    Ruihua Xu

    Recruiting

  • The First Affiliated Hospital - Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310003

    site coordinator

    Recruiting

  • Wenzhou Medical University - The First Affiliated Hospital

    Wenzhou, Zhejiang, 325000

    site coordinator

    Recruiting

Other trials in China

Australia3 sites, 3 recruiting

  • Gosford Hospital

    Gosford, New South Wales, 2250

    site coordinator

    Recruiting

  • Monash Health

    Melbourne

    Sophia Frentzas, sophia.frentzas@monash.edu

    Sophia Frentzas

    Recruiting

  • One Clinical Research - Nedlands

    Nedlands, Western Australia, 6009

    site coordinator

    Recruiting

Other trials in Australia

Canada2 sites, 2 recruiting

  • The Ottawa Hospital - General Campus

    Ottawa

    Jura Nakamura, junakamura@ohri.ca

    Scott Laurie

    Recruiting

  • Princess Margaret Hospital

    Toronto, Toronto

    Albiruni Razak, Albiruni.razak@uhn.ca

    Albiruni Razak

    Recruiting

Other trials in Canada

About this study

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

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)

Being tested
YL211, YL211+Pembrolizumab, YL211 + Pembro or Pembro+ Pemetrexed + (Carboplatin or Cisplatin)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • YL211Drug

    Patients will be treated with YL211 intravenous (IV) infusion only.

  • YL211+PembrolizumabDrug

    Patients will be treated with YL211 and Pembro by infusion.

  • YL211 + Pembro or Pembro+ Pemetrexed + (Carboplatin or Cisplatin)Drug

    participants will receive therapy YL211 + Pembro or Pembro+ Pemetrexed + (Carboplatin or Cisplatin) by infusion.(Part 6)

Study groups in NCT06384352
Study groupRoleWhat they receive
Part 1ExperimentalYL211 Monotherapy Dose Esclation
Receives: Drug: YL211
Part 2ExperimentalYL211 Monotherapy Backfill
Receives: Drug: YL211
Part 3ExperimentalYL211 Monotherapy Dose Expansion
Receives: Drug: YL211
Part 4ExperimentalYL211 + Pembro Combination Therapy Dose Esclation
Receives: Drug: YL211+Pembrolizumab
Part 5ExperimentalYL211 + Pembro Combination Therapy Backfill
Receives: Drug: YL211+Pembrolizumab
Part 6Active comparatorYL211 + Pembro Combination Therapy or Pembro + Chemo Combination Therapy Dose Expansion
Receives: Drug: YL211 + Pembro or Pembro+ Pemetrexed + (Carboplatin or Cisplatin)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Nature and frequency of adverse events (AEs) with severity determined according to NCI CTCAE v5.0 (Part 1 and Part 4)

    AE's

    Measured: Approximately within 36 months

  2. Nature and frequency of dose-limiting toxicities (DLTs) (Part 1 and Part 4)

    DLTs

    Measured: Approximately within 36 months

  3. Nature and frequency of AEs with severity, physical examination findings (including ECOG PS), vital sign measurements, standard clinical laboratory parameters, SpO2 measurements, ECG parameters, and ECHO findings (Part 2 and Part 5)

    Safety

    Measured: Approximately within 36 months

  4. ORR assessed using RECIST version 1.1 (Part 2 and Part 5)

    Efficacy

    Measured: Approximately within 36 months

  5. PFS using RECIST version 1.1 defined as the time interval of randomization to the date of first documentation of PD or death due to any cause, whichever occurs first (Part 3 and Part 6)

    Efficacy

    Measured: approximately 36 months

  6. Nature and frequency of AEs with severity, physical examination findings (including ECOG PS), vital sign measurements, standard clinical laboratory parameters, SpO2 measurements, ECG parameters, and ECHO findings (Part 3 and Part 6)

    Safety

    Measured: approximately within 36 months

Secondary outcomes (12)

  1. physical examination findings (including Eastern Cooperative Oncology Group performance status; ECOG PS), vital sign measurements, standard clinical laboratory parameters, SpO2 measurements, ECG parameters, and ECHO findings (Part 1 and Part 4)

    other safety endpoints

    Measured: Approximately within 36 months

  2. PK enpoints (Part 1 and Part 4)

    Pharmacokinetic endpoints: for each participant will be estimated using standard non-compartmental methods. Descriptive statistics will be provided for all serum concentration data and PK parameter values, with a break down by dose level/cohort as appropriate. PK parameters of YL211-ADC, YL211-TAb, unconjugated payload YL0010014, metabolite YL0010034 and if applicable, other potential metabolite(s), include but not limited to area under the curve (AUC), maximum concentration (Cmax), trough concentration (Ctrough), time of maximum observed concentration (Tmax), clearance (CL), volume of distribution (Vd), and half-life time (t1/2)

    Measured: Approximately within 36 months

  3. Incidence of anti-YL211 antibody (ADA) (Part 1 and Part 4)

    ADA

    Measured: Approximately within 36 months

  4. Efficacy endpoints (Part 1 and Part 4)

    Tumor response will be evaluated using the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Efficacy variables include objective response rate (ORR, the sum of complete response [CR] rate and partial response [PR] rate), disease control rate (DCR, the sum of CR rate, PR rate, and stable disease [SD] rate), duration of response (DoR), duration of SD, time to response (TTR), and progression free survival (PFS), overall survival (OS), percent change in target lesion, time on therapy of the most recent prior regimen the participant received and that of YL211. The efficacy variable(s) will be also evaluated at 18 weeks after Day 1 of Cycle 1.

    Measured: approximately 36 months

  5. PK parameters of YL211-ADC, YL211-TAb, unconjugated payload YL0010014, and if applicable, potential metabolite(s), including but not limited to AUC, Cmax, Ctrough, Tmax, CL, Vd, and t1/2 (Part 2 and Part 5)

    PK

    Measured: approximately 36 months

  6. DCR, DoR, TTR, PFS, OS, and best tumor response assessed using RECIST version 1.1 (Part 2 and Part 5)

    Measured: approximately 36mo

  7. Incidence of ADA (Part 2 and Part 5)

    Measured: approximately 36mo

  8. c-MET protein expression level in tumor tissues and its relationship with efficacy endpoints (Part 5)

    Measured: approximately 36mo

  9. Plasma or serum concentration of YL211-ADC, YL211-TAb, unconjugated payload YL0010014, and if applicable, potential metabolite(s), at specified time points (Part 3 and Part 6)

    Measured: approximately 36mo

  10. Incidence of ADA (Part 3 and Part 6)

    Measured: approximately 36mo

  11. ORR, DCR, DoR, TTR, OS, and best tumor response assessed using RECIST version 1.1 (Part 3 and Part 6)

    Measured: approximately 36mo

  12. c-MET protein expression level in tumor tissues and its relationship with efficacy endpoints (Part 3 and Part 6)

    Measured: Approximately 36mo

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Apr 2024
  2. Study start1 May 2024
  3. Primary completion30 Jun 2031 (estimated)
  4. Study completion30 Jun 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
Sequential: (Dose escalation Parts 1 and 4) Parallel Backfill (Parts 2 and 5) Dose expansion(Parts 3 and 6)
Masking
None (open label)
Enrolment
500 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06384352
Sponsor's protocol ID
YL211-INT-101-01
Status last verified
Aug 2026
First submitted
26 Mar 2024
Last updated
13 Aug 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing YL211, YL211+Pembrolizumab and YL211 + Pembro or Pembro+ Pemetrexed + (Carboplatin or Cisplatin) in people with Advanced Solid Tumors, run by MediLink Therapeutics (Suzhou) Co., Ltd. at 21 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 21 sites in United States, China, Australia, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact MediLink Study Team (+86 0512-62858368, clinicaltrials@medilinkthera.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Nature and frequency of adverse events (AEs) with severity determined according to NCI CTCAE v5.0 (Part 1 and Part 4) (time frame: Approximately within 36 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06384352.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2026.

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