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Non Small Cell Lung CancerPhase 2NCT07202364

A Study of YL202 in Patients With Advanced Solid Tumors

A Phase 2 study testing YL202 in people with Non Small Cell Lung Cancer and Colorectal Cancer, run by MediLink Therapeutics (Suzhou) Co., Ltd. at 1 site 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
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Trial summary

This study is a multicenter, open-label, phase II study of YL202 in China to evaluate the efficacy, safety, and PK characteristics of YL202 in selected patients with advanced solid tumors. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
YL202
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteChina
Study dates
4 Aug 2025to 28 Feb 2027
Phase
Phase 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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subjects must meet all the following criteria to be included in the study:
  • Subjects who are aware of relevant study information prior to the start of the study, and voluntarily sign and date on the informed consent form (ICF).
  • Subjects aged ≥18 years at the time of giving informed consent
  • Body mass index (BMI) within the range of 18 to 32 kg/m2.
  • Subjects with histologically or cytologically confirmed non-Sq NSCLC/CRC/CC or other advanced solid tumor, and had received 1-2 lines of systemic therapy in the advanced/metastatic setting
  • There is at least one extracranial measurable lesion as the target lesion per the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
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  • Archived or fresh tumor tissue samples are available.
  • Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0 or 1.
  • The function of organs and bone marrow meets the requirements within 7 days prior to the first dose
  • Female subjects of childbearing potential must agree to adopt highly effective contraceptive measures from screening throughout the study period and within at least 6 months after the last dose of the investigational product. Male subjects must agree to adopt highly effective contraceptive measures from screening throughout the study period and within at least 6 months after the last dose of the investigational product.
  • Expected survival ≥3 months.
  • Be capable of and willing to comply with the visits and procedures stipulated in the study protocol.

Who cannot join

  • Subjects who meet any of the following criteria should be excluded from the study:
  • Prior drug therapy targeting HER3
  • 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 prior to the first dose of the investigational product.
  • Patients who received major surgery (excluding diagnostic surgery) within 4 weeks prior to the first dose of the investigational product or those who are expected to receive major surgery during the study.
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  • Prior treatment with allogeneic bone marrow transplantation or solid organ transplantation.
  • Prior treatment with systemic steroids (prednisone >10 mg/day or equivalent) or other immunosuppressive treatment within 2 weeks prior to the first dose of the investigational product.
  • Patients who received any live vaccine within 4 weeks prior to the first dose of the investigational product or those who plan to receive live vaccine during the study period.
  • Meningeal metastasis or cancerous meningitis.
  • Brain metastasis or spinal cord compression.
  • Patients with uncontrolled or clinically significant cardiovascular diseases.
  • Clinically significant complicated pulmonary disorders.
  • Medical history of hepatic encephalopathy within 6 months prior to the first dose.
  • Subjects with active or chronic corneal disorders, or other active eye disorders requiring continuous treatment, or any clinically significant corneal disorders that preclude adequate monitoring of drug-induced keratopathy.
  • Diagnosed with Gilbert's syndrome.
  • Significantly symptomatic or unstable pleural effusion, peritoneal effusion, and pericardial effusion, or those requiring repeated drainage.
  • Medical history of gastrointestinal perforation and/or fistula within 6 months prior to the first dose, or active gastric and duodenal ulcers, ulcerative colitis, or other gastrointestinal diseases that may cause hemorrhage or perforation in the opinion of the investigator.
  • Serious infection prior to the first dose (National Cancer Institute-Common Terminology Criteria for Adverse Events [NCI CTCAE] v5.0 grade ≥3),
  • Patients with severe coagulopathy or other diseases with evident risk of bleeding.
  • Patients with uncontrolled diabetes mellitus.
  • Human immunodeficiency virus (HIV) infection; positive syphilis antibody and a positive titer result.
  • Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
  • Medical history of any other primary malignancies within 5 years prior to the first dose of the investigational product, except fully resected non-melanoma skin cancer, cured in-situ disease, or other cured solid tumors.
  • Unresolved toxicity of previous anti-tumor therapy,
  • History of severe hypersensitivity to inactive ingredients in the drug substance (DS) and drug product (DP) or other monoclonal antibodies.
  • Lactating women, or women who are confirmed pregnant via a pregnancy test within 3 days prior to the first dose.
  • Have any diseases, medical conditions, organ system dysfunction, or social conditions that may interfere with the subject ability to sign the ICF, adversely affect the subject ability 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

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

yongchang zhang, Ph.D. contact

+86 13873123436

zhangyongchang@csu.edu.cn

China1 site, 1 recruiting

  • Hunan Provincial Tumor Hospital

    Changsha, Hunan, 410006

    Coordinator Clinical operation director, +86 0512-62858368, clinicaltrials@medilinkthera.com

    Mei Yin He, Bachelor

    Recruiting

Other trials in China

About this study

Official title: A Multicenter, Open-Label, Phase II Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of YL202 in Selected Patients With Advanced Solid Tumors

This study is a multicenter, open-label, phase II study of YL202 in China to evaluate the efficacy, safety, and PK characteristics of YL202 in selected patients with advanced solid tumors.

Read the detailed description

This study is a multicenter, open-label, phase II study of YL202 in China to evaluate the efficacy, safety, and PK characteristics of YL202 in the advanced non small cell lung cancer/colorectal cancer/cervical cancer, etc. YL202 is an antibody-drug conjugate (ADC) that targets HER3 protein

Being tested
YL202
Medical subject headings
Carcinoma, Non-Small-Cell Lung, Colorectal Neoplasms, Uterine Cervical Neoplasms

What participants receive

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

  • YL202Drug

    YL202 will be intravenously infused over 60±10 min

Study groups in NCT07202364
Study groupRoleWhat they receive
Cohort EGFRm NSCLC, AGA-nsq-NSCLC, Cervical Cancer and Cervical Cancer/1.6mgExperimentalThis includes a dose-exploration period and a dose-expansion period.
Receives: Drug: YL202
Cohort Colorectal CancerExperimentalThis includes a dose-exploration period and a dose-expansion period. Participants in Cohort Colorectal Cance will be randomized in a 1:1 ratio to one of the two dose levels.
Receives: Drug: YL202

What is being measured

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

  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

Secondary outcomes (7)

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

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

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

    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 posted1 Oct 2025
  2. Study start4 Aug 2025
  3. Primary completion31 Jan 2027 (estimated)
  4. Study completion28 Feb 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 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07202364
Sponsor's protocol ID
YL202-CN-203-01
Status last verified
Mar 2026
First submitted
23 Sep 2025
Last updated
14 Oct 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing YL202 in people with Non Small Cell Lung Cancer and Colorectal Cancer, run by MediLink Therapeutics (Suzhou) Co., Ltd. at 1 site 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 12 inclusion and 28 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 14 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 phase mean?

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 yongchang zhang, Ph.D. (+86 13873123436, zhangyongchang@csu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective response rate (ORR) (time frame: Up to approximately 3 years). 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 NCT07202364.

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 14 Oct 2026.

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Clinical Trial NCT07202364 | AzTrials