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Advanced Solid TumorsPhase 1/2NCT07169994

A Study of YL202 in Combination With Other Anti-tumor Therapies in Patients With Advanced Solid Tumors

A Phase 1/2 study testing YL202 for injection; Toripalimab injection and YL202 for injection; Furmonertinib Mesilate Tablets in people with Advanced Solid Tumors and Breast Cancer, run by MediLink Therapeutics (Suzhou) Co., Ltd. at 20 sites in China.

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 Ib/II study of YL202 in combination with other anti-tumor therapies to Evaluate the Safety, Tolerability, and Efficacy in Patients with Advanced Solid Tumors Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
YL202 for injection; Toripalimab injection and YL202 for injection; Furmonertinib Mesilate Tablets
Could I receive a placebo?
No, everyone receives an active treatment
How many people
414 participants
Where
20 sitesChina
Study dates
2 Sep 2025to 30 Nov 2027
Phase
Phase 1/2
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 to 75 years
  • 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 informed consent form (ICF)
  • Able and willing to comply with protocol visits and procedures
  • Aged between 18 to 75 years
  • Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1
  • Previously treated by standard treatment or have not been treated for metastatic setting;
  • 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

  • With prior drug therapy targeting HER3 (including antibodies, antibody-drug conjugates [ADCs]), chimeric antigen receptor T-cell immunotherapy (CAR-T), and other drugs).
  • Previously intolerant to topoisomerase I inhibitors or ADC therapy composed of topoisomerase I inhibitors.
  • Are participating in another clinical study, unless it is an observational (non-interventional) clinical study or in the follow-up period of an interventional study.
  • The washout period from the previous anti-tumor therapy is insufficient before the first dose of the investigational product.
  • Patients who have received major surgery (excluding diagnostic surgery) within 4 weeks before the first dose of the investigational product or those who are expected to receive major surgery during the study.
  • Prior treatment with allogeneic bone marrow transplantation or solid organ transplantation.
Show all 23Show fewer
  • Prior treatment with systemic steroids (prednisone > 10 mg/day or equivalent) or other immunosuppressive treatment within 2 weeks before the first dose of the investigational product.
  • Patients who have received any live vaccine within 4 weeks before the first dose of the investigational product or those who plan to receive live vaccine during the study period.
  • With meningeal metastasis or cancerous meningitis.
  • With brain metastasis or spinal cord compression.
  • Patients with uncontrolled or clinically significant cardiovascular diseases.
  • Clinically significant complicated pulmonary disorders.
  • Patients diagnosed with Gilbert syndrome.
  • Those with uncontrolled effusion in the third space requiring repeated drainage.
  • With a medical history of gastrointestinal perforation and/or fistula within 6 months before the first dose, or with active gastric and duodenal ulcers, ulcerative colitis, or other gastrointestinal diseases that may lead to hemorrhage or perforation according to the investigator.
  • With serious infection before the first dose.
  • With known human immunodeficiency virus (HIV) infection.
  • With active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
  • With a medical history of any other primary malignancies within 5 years before the first dose of the investigational product.
  • Unrelieved toxicity of previous anti-tumor therapy.
  • With a history of severe hypersensitivity to inactive ingredients in the raw materials and drug product or other monoclonal antibodies.
  • Lactating women, or women who are confirmed pregnant via a pregnancy test within 3 days before the first dose.
  • With any diseases, medical conditions, organ system dysfunction, or social conditions that may interfere with the ability of subjects to sign the ICF, adversely affect the ability of subjects to cooperate and participate in the study, or affect the interpretation of study results, including but not limited to mental illness or substance/alcohol abuse, in the opinion of the investigator.

Trial locations and contacts

20 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Ning Wang, MM contact

+86 0512-62858368

info@medilinkthera.com

20 sites in 1 country

China20 sites, 20 recruiting

  • Anyang Cancer Hospital

    Anyang, Henan, 455100

    Study Coordinator

    Not yet recruiting

  • Affiliated Hospital Of Hebei University

    Baoding, Hebei, 71051

    Study Coordinator

    Not yet recruiting

  • The First People's Hospital of Changde City

    Changde, Hunan, 415000

    Study Coordinator

    Not yet recruiting

  • Affiliated Zhongshan Hospital Dalian University

    Dalian, Liaoning, 116001

    Study Coordinator

    Not yet recruiting

  • Fujian Cancer Hospital

    Fuzhou, Fujian, 350014

    Study Coordinator

    Not yet recruiting

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong, 510555

    Study Coordinator

    Not yet recruiting

  • Harbin Medical University Cancer Hospital

    Harbin, Heilongjiang, 150081

    Study Coordinator

    Not yet recruiting

  • Anhui Provincial Hospital(The First Affiliated Hospital of Ustc)

    Hefei, Anhui, 230001

    Study Coordinator

    Not yet recruiting

  • Affiliated Zhongshan Hospital Dalian University

    Jinan, Shandong, 250117

    Study Coordinator

    Not yet recruiting

  • The First Affiliated Hospital of Henan University of Science and Technology

    Luoyang, Henan, 471023

    Study Coordinator

    Not yet recruiting

  • Meizhou People's Hospital（Huangtang Hospital）Meizhou Academy of Medical Sciences

    Meizhou, Guangdong, 514031

    Study Coordinator

    Not yet recruiting

  • Jiangxi Cancer Hospital

    Nanchang, Jiangxi

    Study Coordinator

    Not yet recruiting

  • Jiangsu Province Hospital（The First Affiliated Hospital With Nanjing Medical University, Jiangsu Women And Children Health Hospital)

    Nanjing, Jiangsu, 210029

    Study Coordinator

    Not yet recruiting

  • Ghang xi Medical University Cancer Hospital

    Nanning, Guangxi, 530028

    Study Coordinator

    Not yet recruiting

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality, 201321

    Study Coordinator

    Recruiting

  • Liaoning cancer hospital &institute

    Shenyang, Liaoning, 110042

    Study Coordinator

    Not yet recruiting

  • Sichuan Academy of Medical Sciences&Sichuan Provincial People's Hospital

    Sichuan, Sichuan, 610072

    Study Coordinator

    Not yet recruiting

  • Shanxi Cancer Hospital

    Taiyuan, Shanxi, 30013

    Study Coordinator

    Not yet recruiting

  • Tianjin Cancer Hospital Airport Hospital

    Tianjin, Tianjin Municipality, 300300

    Study Coordinator

    Not yet recruiting

  • Xiangyang Central Hospital

    Xiangyang, Hubei, 441138

    Study Coordinator

    Not yet recruiting

Other trials in China

About this study

Official title: A Multi-center, Open-Label, Phase Ib/II Study of YL202 in Combination With Anti-tumor Therapy to Evaluate the Safety, Tolerability, and Efficacy in Patients With Advanced Solid Tumors

This is a multicenter, open-label, phase Ib/II study of YL202 in combination with other anti-tumor therapies to Evaluate the Safety, Tolerability, and Efficacy in Patients with Advanced Solid Tumors

Being tested
YL202 for injection; Toripalimab injection, YL202 for injection; Furmonertinib Mesilate Tablets
Medical subject headings
Breast Neoplasms, Carcinoma, Non-Small-Cell Lung

What participants receive

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

  • YL202 for injection; Toripalimab injectionDrug

    Part 1: YL202 and Toripalimab will be administered intravenously.

    Part 3: participants will receive escalating doses of YL202 and fixed dose of Toripalimab until YL202 doses for optimization are determined.

    Dose expansion stage: participants will receive a dose of YL202 not exceeding the maximum dose level achieved during the dose-escalation stage and fixed dose of Toripalimab

  • YL202 for injection; Furmonertinib Mesilate TabletsDrug

    Part 2: YL202 will be administered intravenously，Furmonertinib Mesilate Tablets will be administered orally.

    Dose escalation stage: participants will receive escalating doses of YL202 and fixed dose of Furmonertinib Mesilate until YL202 doses for optimization are determined.

    Part 4: participants will receive a dose of YL202 not exceeding the maximum dose level achieved during the dose-escalation stage and fixed dose of Furmonertinib Mesilate.

Study groups in NCT07169994
Study groupRoleWhat they receive
YL202 in combination with ToripalimabExperimentalPart 1 (dose escalation stage and backfill stage) \& Part 3 (dose expansion stage): YL202 for injection in combination with Toripalimab injection
Receives: Drug: YL202 for injection; Toripalimab injection
YL202 in combination with Furmonertinib MesilateExperimentalPart 2 (dose escalation stage and backfill stage) \& Part 4 (dose expansion stage): YL202 for injection in combination with Furmonertinib Mesilate Tablets
Receives: Drug: YL202 for injection; Furmonertinib Mesilate Tablets

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: 21 days after the first dose was administered to each subject.

  2. Nature and frequency of adverse events (AEs)

    Nature and frequency of AEs with severity is aim to evaluate the safety of YL202 combination.

    Measured: 42 days after the end of treatment (EOT).

Secondary outcomes (9)

  1. 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.

  2. 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

  3. Characterize Pharmacokinetics (PK) parameter Cmax

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

    Measured: Up to approximately 3 years

  4. Characterize Pharmacokinetics (PK) parameter Ctrough

    Trough concentration

    Measured: Up to approximately 3 years

  5. Characterize Pharmacokinetics (PK) parameter Tmax

    Time to maximum observed concentration

    Measured: Up to approximately 3 years

  6. 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

  7. Characterize Pharmacokinetics (PK) parameter Vd

    volume of distribution

    Measured: Up to approximately 3 years

  8. 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

  9. Immunogenicity endpoint: Incidence of anti-YL202 antibody (ADAs).

    The presence of ADAs in patients treated with YL202 will be assessed to evaluate immunogenicity.

    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 posted12 Sep 2025
  2. Study start2 Sep 2025
  3. Primary completion1 Sep 2026 (estimated)
  4. Study completion30 Nov 2027 (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 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
414 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07169994
Sponsor's protocol ID
YL202-CN-204-02
Status last verified
Sep 2025
First submitted
3 Sep 2025
Last updated
12 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing YL202 for injection; Toripalimab injection and YL202 for injection; Furmonertinib Mesilate Tablets in people with Advanced Solid Tumors and Breast Cancer, run by MediLink Therapeutics (Suzhou) Co., Ltd. at 20 sites in China.

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 23 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 12 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites in 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 combined 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.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 Ning Wang, MM (+86 0512-62858368, info@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: 21 days after the first dose was administered to each subject.). The study lists 2 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 NCT07169994.

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 12 Sep 2025.

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