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Advanced Solid TumorPhase 1NCT06859762

A First-in-Human Study of YL217 in Patients With Advanced Solid Tumors

A Phase 1 study testing YL217, Bevacizumab and 5-FU with leucovorin in people with Advanced Solid Tumor, run by MediLink Therapeutics (Suzhou) Co., Ltd. at 21 sites in 2 countries.

Recruiting

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

Sites and contacts
Official record
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Trial summary

A Phase 1 First-in-Human study of YL217 in Patients with Advanced Solid Tumors Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Solid Tumor
What is being tested?
YL217, Bevacizumab and 5-FU with leucovorin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
630 participants
Where
21 sitesin 2 countries
Study dates
2 Jul 2025to Jul 2030
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 study before the start of the study and voluntarily sign their name and date in the ICF
  • Able and willing to comply with protocol visits and procedures
  • Age≥ 18 years
  • ECOG PS of 0 or 1
  • Pathologically confirmed diagnosis of an advanced solid tumor. For CRC cohorts: : Histologically or cytologically documented locally advanced unresectable or metastatic colorectal carcinoma that is not eligible for curative surgery and/or definitive chemoradiotherapy
  • Adequate organ and bone marrow function.
  • Have at least 1 extracranial measurable tumor lesion.
  • Adequate archival formalin-fixed paraffin embedded （FFPE） tissue from prior biopsy.

Who cannot join

  • Prior treatment with an agent targeting CDH17
  • Prior discontinuation of a topoisomerase I inhibitor due to treatment-related toxicities.
  • Have received an ADC consisting of a topoisomerase I inhibitor.
  • Concurrent enrollment in another clinical study, unless it is an observational clinical study.
  • Inadequate washout period for prior anticancer treatment before the first dose of study drug
  • Undergone major surgery within 4 weeks before the first dose of study drug or expect major surgery during the study, minor procedures (e.g., core needle biopsy, superficial biopsy) within 7 days before the first dose of study drug.
Show all 17Show fewer
  • Received long term systemic steroids or other immunosuppressive therapy within 2 weeks before the first dose of study drug.
  • Received any live vaccine within 4 weeks before the first dose of study drug or intend to receive a live vaccine during the study.
  • Diagnosis or evidence of spinal cord compression or leptomeningeal carcinomatosis.
  • Uncontrolled or clinically significant cardiovascular and cerebrovascular diseases.
  • A history of non-infectious interstitial lung disease (ILD)/pneumonitis that requires steroids, current active ILD/pneumonitis.
  • Have clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses.
  • Uncontrolled third-space fluid that requires repeated drainage.
  • Digestive system disease that may cause bleeding, perforation, jaundice, fistula, GI obstruction within 6 months prior to the first dose of study drug administration or have active inflammatory bowel disease.
  • An active tuberculosis based on medical history.
  • Known human immunodeficiency virus (HIV) infection.
  • Active hepatitis C infection.

Trial locations and contacts

21 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

Angie Cao, MD contact

+86 0512-62858368

clinicaltrials@medilinkthera.com

21 sites in 2 countries

United States12 sites, 12 recruiting

  • University of Cincinnati Medical Center

    Cincinnati, Ohio, 45219

    Study Coordinator

    Recruiting

  • Cleveland Clinic Taussig Cancer Institute

    Cleveland, Ohio, 44195

    Study Coordinator

    Recruiting

  • Karmanos Cancer Institute

    Detroit, Michigan, 48201

    Study Coordinator

    Recruiting

  • Duke University Medical Center (DUMC)

    Durham, North Carolina, 27710

    Study Coordinator

    Recruiting

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030

    Study Coordinator

    Recruiting

  • The University of Kansas Cancer Center (KUCC)

    Kansas City, Kansas, 66205

    Study Coordinator

    Recruiting

  • University of Wisconsin Health - UW Carbone Cancer Center

    Madison, Wisconsin, 53792

    Study Coordinator

    Recruiting

  • Yale Cancer Center

    New Haven, Connecticut, 06519

    Recruiting

  • Columbia University Irving Medical Center

    New York, New York, 10032

    Study Coordinator

    Recruiting

  • Mayo Clinic Arizona

    Phoenix, Arizona, 85054

    Study Coordinator

    Recruiting

  • UT Health San Antonio - Mays Cancer Center

    San Antonio, Texas, 78229

    Study Coordinator

    Recruiting

  • UCLA Hematology/Oncology - Santa Monica

    Santa Monica, California, 90404

    Study Coordinator

    Recruiting

Other trials in United States

China9 sites, 9 recruiting

  • Peking Union Medical College Hospital

    Beijing, Bejing, 100730

    Study Coordinator

    Recruiting

  • The Sixth Affiliated Hospital of Sun Yat-sen University

    Guangzhou, Guangdong, 510655

    Not yet recruiting

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang, 310022

    Study Coordinator

    Recruiting

  • Harbin Medical University Cancer Hospital

    Harbin, Heilongjiang, 150081

    Study Coordinator

    Recruiting

  • Cancer Hospital of Shandong First Medical University

    Jinan, Shandong, 250117

    Study Coordinator

    Recruiting

  • The First Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi, 330006

    Not yet recruiting

  • Ruijin Hospital, Shanghai Jiaotong University School of Medicine

    Shanghai, Shanghai Municipality, 200025

    Study Coordinator

    Recruiting

  • The First Affiliated Hospital of China Medical University

    Shenyang, Liaoning, 110001

    Not yet recruiting

  • Tianjin Medical University Cancer Institute & Hospital

    Tianjin, Tianjin Municipality, 300060

    Study Coordinator

    Recruiting

Other trials in China

About this study

Official title: A Phase 1, Multicenter, Open-Label, First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of YL217 in Patients With Advanced Solid Tumors

A Phase 1 First-in-Human study of YL217 in Patients with Advanced Solid Tumors

Read the detailed description

YL217 is an antibody-drug conjugate (ADC) that targets CDH17 (Cadherin-17) protein and is being developed for the treatment of cancer. YL217 is comprised of three components: 1) YL217-mAb, a CDH17-targeting recombinant humanized immunoglobulin G1 (IgG1) monoclonal antibody, 2) YL0010014, a topoisomerase I inhibitor, and 3) an enzymatically cleavable methylsulfonyl pyrimidine tripeptide drug linker.

The in vivo anti-tumor efficacy of YL217 was evaluated in immune-deficient mice bearing human colorectal cancer, gastric cancer and patient derived colorectal cancer xenograft tumors. The results indicated that YL217 was well tolerated, and YL217 suppressed growth of established human tumors in a dose-dependent manner in cancer cells or patient derived xenograft models.

Therefore, in order to meet the huge unmet medical needs in the field of gastrointestinal cancer treatment, it is planned to conduct the first human phase I clinical study of YL217 in patients with advanced solid tumors.

Being tested
YL217, Bevacizumab, 5-FU with leucovorin

What participants receive

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

  • YL217Drug

    Patients will receive specific dose of YL217 administered via intravenous(IV)infusion.

  • BevacizumabDrug

    Participants will receive bevacizumab administered via intravenous(IV) infusion,at 5mg/kg,Q2W.

  • 5-FU with leucovorinDrug

    Participants will receive 5 fluorouracil 2400mg/m2 and leucovorin 400mg/m2, administered via intravenous (IV) infusion, Q2W

Study groups in NCT06859762
Study groupRoleWhat they receive
Combo-Dose Escalation,Backfill and ExpansionExperimentalParticipants will receive YL217 in combination of bevacizumab with or without 5-FU/LV
Receives: Drug: YL217; Drug: Bevacizumab; Drug: 5-FU with leucovorin
Mono-Dose Escalation,Backfill and ExpansionExperimentalParticipants will receive YL217 monotherapy
Receives: Drug: YL217

What is being measured

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

  1. Nature and frequency of dose-limiting toxicity(DLT)

    The purpose of DLT is to find maximum tolerated dose (MTD).

    Measured: Up to approximately 3 years

  2. Nature and frequency of adverse events (AEs) with severity

    Nature and frequency of AEs with severity is aim to evaluate the safety of YL217.

    Measured: Up to approximately 3 years

  3. objective response rate (ORR)

    ORR: defined as the proportion of patients who achieved a best overall response of complete response (CR) or partial response (PR).

    Measured: Up to approximately 3 years

Secondary outcomes (16)

  1. Eastern Cooperative Oncology Group performance status (ECOG PS)

    Deterioration of Eastern Cooperative Oncology Group performance status (ECOG PS)

    Measured: Up to approximately 3 years

  2. To evaluate safety endpoint of peripheral oxygen saturation (SpO2)

    Measured: Up to approximately 3 years

  3. Characterize Pharmacokinetics(PK) parameter AUC

    The area under curve: AUC is the total amount of YL217 in bloodstream after drug administration.

    Measured: Up to approximately 3 years

  4. Characterize Pharmacokinetics(PK) parameter Cmax

    Maximum concentration：The highest measured concentration of YL217 in the bloodstream.

    Measured: Up to approximately 3 years

  5. Characterize Pharmacokinetics(PK) parameter Ctrough

    Trough concentration

    Measured: Up to approximately 3 years

  6. Characterize Pharmacokinetics(PK) parameter Tmax

    Time to maximum observed concentration

    Measured: Up to approximately 3 years

  7. Characterize Pharmacokinetics(PK) parameter CL

    Clearance： defined as the amount of drug removed from the bloodstream by the body per unit of time.

    Measured: Up to approximately 3 years

  8. Characterize Pharmacokinetics(PK) parameter Vd

    volume of distribution

    Measured: Up to approximately 3 years

  9. Characterize Pharmacokinetics(PK) parameter t1/2

    Half-life time：defined as the time it takes for the concentration of the drug in plasma or serum to be reduced by 50%.

    Measured: Up to approximately 3 years

  10. Immunogenicity endpoint: Incidence of anti-YL217 antibody (ADAs).

    The presence of ADAs in patients treated with YL217 will be assessed to evaluate immunogenicity.

    Measured: Up to approximately 3 years

  11. Disease control rate (DCR)

    DCR: defined as the proportion of patients who achieved a best overall response of complete response (CR), partial response (PR) or stable disease (SD).

    Measured: Up to approximately 3 years

  12. Duration of response (DoR)

    DoR: defined as the time interval from the date of the first documentation of objective response (CR or PR) to the date of the first documentation of progressive disease (PD).

    Measured: Up to approximately 3 years

  13. Time to response (TTR)

    TTR: defined as the time interval from the date of the first dose of study drug to the date of the first documentation of objective response (CR or PR).

    Measured: Up to approximately 3 years

  14. Depth of response (DpR)

    DpR: defined as the proportion of target lesion shrinkage from baseline to maximum tumor size.

    Measured: Up to approximately 3 years

  15. Progression-free survival (PFS)

    PFS: defined as the time interval from the date of the first dose of study drug to the date of first documentation of PD or death due to any cause, whichever occurs first.

    Measured: Up to approximately 3 years

  16. Overall survival (OS)

    OS: defined as the time interval from the date of the first dose of study drug to the date of death due to any cause.

    Measured: Up to approximately 3 years

Timeline

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

  1. First posted5 Mar 2025
  2. Study start2 Jul 2025
  3. Primary completionJul 2028 (estimated)
  4. Study completionJul 2030 (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
Sequential
Model description
A Phase 1, Multicenter, Open-Label, First-in-Human Study
Masking
None (open label)
Enrolment
630 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06859762
Sponsor's protocol ID
YL217-INT-101-01
Status last verified
Sep 2026
First submitted
18 Feb 2025
Last updated
18 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing YL217, Bevacizumab and 5-FU with leucovorin in people with Advanced Solid Tumor, run by MediLink Therapeutics (Suzhou) Co., Ltd. at 21 sites in 2 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 8 inclusion and 17 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 18 Sep 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. 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 Angie Cao, MD (+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 dose-limiting toxicity(DLT) (time frame: Up to approximately 3 years). The study lists 3 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 NCT06859762.

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 18 Sep 2026.

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