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Non Small Cell Lung CancerPhase 1NCT05653752

A Study of YL202 in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer and Breast Cancer

A Phase 1 study testing YL202 in people with Non Small Cell Lung Cancer and Breast Cancer, run by MediLink Therapeutics (Suzhou) Co., Ltd. at 13 sites in 2 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

This is a phase 1, multicenter, open-label, first-in-human study of YL202 conducted in the United States and China. The study will evaluate the safety and tolerability of YL202 in patients with locally advanced or metastatic epidermal growth factor receptor (EGFR)-mutated NSCLC or hormone receptor (HR)-positive and… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non Small Cell Lung Cancer, Breast Cancer
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
80 participants
Where
13 sitesin 2 countries
Study dates
20 Dec 2022to Dec 2026
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

  • Patients must satisfy all of the following criteria to be included in the study:
  • Informed of the trial before the start of the trial and voluntarily sign their name and date on the informed consent form
  • Aged ≥18 years
  • Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 to 2
  • Adequate organ and bone marrow function, defined as follows:
  • Hemoglobin ≥9.0 g/dL (have not received blood transfusion or erythropoietin treatment within 14 days before the first dose)
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  • Absolute neutrophil count ≥1.5 × 109/L (have not received granulocyte colony-stimulating factor or granulocyte-macrophage colony-stimulating factor treatment within 14 days before the first dose)
  • Platelet count ≥100 × 109/L if no demonstrable hepatic metastases or ≥75 × 109/L in the presence of hepatic metastases (have not received platelet transfusion, thrombopoietin, or interleukin-11 treatment within 14 days before the first dose)
  • TBIL ≤1.5 × ULN if no demonstrable hepatic metastases or ≤3 × ULN in the presence of hepatic metastases
  • ALT and AST ≤3 × ULN if no demonstrable hepatic metastases or ≤5 × ULN in the presence of hepatic metastases
  • Serum albumin ≥2.5 g/dL
  • Creatinine clearance ≥60 mL/min (calculated according to Cockcroft Gault formula)
  • Activated partial thromboplastin time and international normalized ratio ≤1.5 × ULN, except for patients receiving anticoagulant therapy, who must have international normalized ratio within therapeutic range as deemed appropriate by the investigator
  • Female patients of childbearing potential must agree to use a highly effective form of contraception and not donate, or retrieve for their own use, ova from the time of screening and throughout the study period, and for at least 6 months after the last dose of study drug. Male patients must agree to use a highly effective form of contraception and not freeze or donate sperm from the time of screening and throughout the study period, and for at least 6 months after the last dose of study drug.
  • Life expectancy of ≥3 months
  • Able and willing to comply with protocol visits and procedures
  • For NSCLC patients:
  • Have a histologically or cytologically confirmed diagnosis of locally advanced or metastatic NSCLC not amenable to curative surgery or radiation
  • Have a documentation of an EGFR-activating mutation (exon 19 deletion or L858R) detected from tumor tissue at diagnosis or thereafter. Participants who have this EGFR mutation detected from blood sample may be eligible on a case-by-case basis after discussion with the sponsor.
  • Have documentation of disease progression on or after, or are intolerant to most recent treatment regimen for locally advanced or metastatic disease. Participants must have received all of the following:
  • Prior treatment with a regimen containing a 3rd-generation EGFR TKI (e.g., osimertinib). Patients receiving a 3rd-generation EGFR TKI at the time of signing informed consent should continue to take the EGFR TKI until 5 days prior to Cycle 1 Day 1
  • Systemic therapy with at least 1 platinum-based chemotherapy regimen
  • Participants in the US must have also received prior treatment with an anti-PD-(L)1 antibody, unless they have high-risk factors indicating preferable avoidance of anti-PD-(L)1 therapy (e.g., intolerance or lack of efficacy is anticipated) Note: Patients who received platinum-based chemotherapy concurrently with anti-PD-(L)1 antibody as one regimen are eligible.
  • For BC patients:
  • Have a histologically or cytologically confirmed diagnosis of unresectable locally advanced or metastatic HR-positive and HER2-negative (IHC 0, 1+, 2+/ISH-) BC (per American Society of Clinical Oncology-College of American Pathologists [ASCO-CAP] guidelines)
  • Have documentation of disease progression on or after, or were intolerant to at least 1 prior line of endocrine therapy in combination with a CDK4/6 inhibitor
  • Have received 0-4 lines of chemotherapy regimens (including ADCs) for locally advanced or metastatic disease
  • Note 1: Prior treatments with PI3K inhibitors, mTOR inhibitors, AKT inhibitors, and PARP inhibitors are allowed.
  • Note 2: If a patient develops disease relapse/progression during or within 6 months after the end of the (neo-)adjuvant therapy, or radical radiotherapy and chemotherapy, the treatment regimen will be counted as one line of treatment for locally advanced or metastatic disease, for the purpose of this inclusion criteria.
  • Have at least 1 measurable tumor lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
  • Willing to provide archival or fresh tumor tissue samples for assessment of HER3 expression level. Patients who are not able to provide tumor samples or have inadequate samples may be eligible after discussion with the sponsor.

Who cannot join

  • Patients who meet any of the following criteria will be disqualified from entering the study:
  • Prior treatment with an agent targeting HER3 (including antibody, ADC, chimeric antigen receptor T cell [CAR-T], and other drugs)
  • Intolerant to prior treatment with a topoisomerase I inhibitor or an ADC that consists of a topoisomerase I inhibitor, including but not limited to topotecan, irinotecan, and DXd (e.g., severe diarrhea)
  • Concurrent enrollment in another clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study
  • Inadequate washout period for prior anticancer treatment before the first dose of study drug, defined as follows:
  • Any cytotoxic chemotherapy or small molecular-targeted therapy (other than EGFR TKI) <2 weeks or 5 half-lives, whichever is shorter
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  • Endocrine therapy <3 weeks
  • Monoclonal antibodies or other biological therapy <3 weeks
  • Herbal medicine with antitumor indications <2 weeks
  • Whole brain radiation therapy <2 weeks or stereotactic brain radiation therapy <1 week
  • Radiotherapy treatment to more than 30% of the bone marrow or with a wide field of radiation <4 weeks or palliative radiation therapy <2 weeks
  • Undergone major surgery (not including diagnostic surgery) within 4 weeks before the first dose of study drug or expect major surgery during the study
  • Prior allogeneic bone marrow transplantation or solid-organ transplantation
  • Received systemic steroids (>20 mg/day of prednisone or its equivalent) or other immunosuppressive therapy within 2 weeks before the first dose of study drug. The following are exceptions to this criterion:
  • Intranasal, inhaled, topical steroids, or local steroid injections (e.g., intra articular injection)
  • Systemic steroids at physiological doses as replacement therapy (e.g., physiological corticosteroid replacement therapy for adrenal or pituitary insufficiency)
  • Steroids as premedication for hypersensitivity reactions (e.g., computed tomography [CT] scan premedication) or steroids as antiemetic premedication
  • Received any live vaccine within 4 weeks before the first dose of study drug or intend to receive a live vaccine during the study
  • A history of leptomeningeal carcinomatosis
  • Brain metastases or spinal cord compression unless asymptomatic or treated and stable off steroids and anti-convulsants for at least 2 weeks before the first dose of study drug
  • Uncontrolled or clinically significant cardiovascular disease, including but not limited to:
  • Medical history of symptomatic congestive heart failure (New York Heart Association class II to IV) or any arterial thromboembolic event (e.g., myocardial infarction, unstable angina, cerebrovascular accident, and transient ischemic attack) within 6 months before the first dose
  • Uncontrolled hypertension, defined as systolic blood pressure (SBP) >160 mm Hg and/or diastolic blood pressure (DBP) >100 mm Hg after antihypertensive therapy
  • Serious cardiac arrhythmia that requires treatment
  • Corrected QT interval by Fridericia's formula (QTcF) prolongation to >470 ms
  • A history of (noninfectious) interstitial lung disease (ILD)/pneumonitis that requires steroids, current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening
  • Clinically significant concomitant pulmonary disease, including but not limited to:
  • Pulmonary embolism within 3 months of the start of study treatment
  • Any autoimmune, connective tissue, or inflammatory disorder (e.g., rheumatoid arthritis, Sjögren's syndrome, sarcoidosis) where there is documented or suspicion of pulmonary involvement at the time of screening
  • Prior complete pneumonectomy
  • Patients with active or chronic corneal disorders, or patients with other active ocular conditions requiring ongoing therapy or with any clinically significant corneal disease that prevents adequate monitoring of drug-induced keratopathy.
  • Have a diagnosis of Gilbert's syndrome
  • Uncontrolled third-space fluid (e.g., pleural effusions, ascites, pericardial effusions) that requires repeated drainage
  • Active gastric and duodenal ulcers, ulcerative colitis, or other gastrointestinal conditions that may cause bleeding or perforation by the investigator's discretion
  • Active infection that requires systemic therapy within 1 week before the first dose. Patients receiving prophylactic anti-infective therapy (e.g., to prevent a urinary tract infection or chronic obstructive pulmonary disease exacerbation) may be eligible after discussion with the sponsor.
  • Known human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV) infection. Patients with HIV, HBV, or HCV infection may be enrolled after evaluation of eligibility based on FDA's guideline Cancer Clinical Trial Eligibility Criteria: Patients with HIV, Hepatitis B Virus, or Hepatitis C Virus Infections
  • Any other primary malignancy within 3 years before the first dose of study drug, except adequately resected non-melanoma skin cancer, curatively treated in situ disease, or other curatively treated solid tumors
  • Unresolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia and pigmentation) not yet resolved to NCI CTCAE Grade ≤1, baseline, or the level specified in the inclusion/exclusion criteria. Patients with chronic Grade 2 toxicities who are asymptomatic or adequately managed with stable medication may be eligible after discussion with the sponsor.
  • A history of severe hypersensitivity reactions to the drug substances, inactive ingredients in the drug product, or other monoclonal antibodies
  • Women who are breastfeeding or pregnant as confirmed by pregnancy tests performed within 3 days before the first dose
  • Any illness, medical condition, organ system dysfunction, or social situation, including but not limited to mental illness or substance/alcohol abuse, deemed by the investigator to be likely to interfere with a patient's ability to sign informed consent, adversely affect the patient's ability to cooperate and participate in the study, or compromise the interpretation of study results.

Trial locations and contacts

13 sites in 2 countries.

13 sites in 2 countries

United States7 sites

  • Karmanos Cancer Institute

    Detroit, Michigan, 48201

  • Next Oncology-Virginia

    Fairfax, Virginia, 22031

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030

  • Next Oncology-Dallas

    Irving, Texas, 75039

  • BRCR Global

    Plantation, Florida, 33322

  • Summit Cancer Center

    Spokane Valley, Washington, 99216

  • UT health east Texas HOPE Cancer Center

    Tyler, Texas, 75701

Other trials in United States

China6 sites

  • Jilin Provincial Cancer Hospital

    Changchun, Jilin, 130012

  • Hunan Cancer Hospital

    Changsha, Hunan, 410013

  • Fujian Cancer Hospital

    Fuzhou, Fujian, 350014

  • The First Affiliated Hospital of Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310003

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang, 310022

  • Taizhou Hospital of Zhejiang Province

    Taizhou, Zhejiang, 317099

Other trials in China

About this study

Official title: A Phase 1, Multicenter, Open-label, First-in-human Study of YL202 in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer and Breast Cancer

This is a phase 1, multicenter, open-label, first-in-human study of YL202 conducted in the United States and China.

The study will evaluate the safety and tolerability of YL202 in patients with locally advanced or metastatic epidermal growth factor receptor (EGFR)-mutated NSCLC or hormone receptor (HR)-positive and HER2-negative BC, which have been heavily treated by standard treatment.

Being tested
YL202
Medical subject headings
Carcinoma, Non-Small-Cell Lung, Breast Neoplasms

What participants receive

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

  • YL202Drug

    YL202 is provided as the lyophilized powder, 200 mg/vial. YL202 will be given intravenously once every 3 weeks (Q3W) as a cycle.

    The initial dose of YL202 will be infused IV into each patient for 90 ±10 minutes. If there is no infusion-related reaction after the initial dose, the second and subsequent doses of YL202 will be infused IV into each patient for 60 ±10 minutes.

Study groups in NCT05653752
Study groupRoleWhat they receive
YL202 Dose escalationExperimentalYL202 will be administrated intravenously (IV) per dose level in which the patients are assigned.
Receives: Drug: YL202

What is being measured

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

  1. Evaluate the occurrence of DLTs during the first cycle

    Measured: At the end of Cycle 1 (each cycle is 21 days)

  2. Evaluate the AEs as characterized by type, frequency, severity, timing, seriousness and relationship to study treatment

    Measured: By the global end of trial date, approximately within 36 months

Secondary outcomes (10)

  1. Characterize the PK parameter AUC

    Measured: Approximately within 36 months

  2. Characterize the PK parameter Cmax

    Measured: Approximately within 36 months

  3. Characterize the PK parameter Ctrough

    Measured: Approximately within 36 months

  4. Characterize the PK parameter CL

    Measured: Approximately within 36 months

  5. Characterize the PK parameter Vd

    Measured: Approximately within 36 months

  6. Characterize the PK parameter t1/2

    Measured: Approximately within 36 months

  7. Assess the incidence of anti-YL202 antibodies

    Measured: Approximately within 36 months

  8. Evaluate the 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: Approximately within 36 months

  9. Evaluate the disease control rate (DCR)

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

    Measured: Approximately within 36 months

  10. Evaluate the best tumor response

    Best tumor response: defined as the maximum percentage change in the sum of longest dimensions of measurable lesion(s) at any time during the study.

    Measured: Approximately within 36 months

Timeline

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

  1. First posted16 Dec 2022
  2. Study start20 Dec 2022
  3. Primary completionDec 2026 (estimated)
  4. Study completionDec 2026 (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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05653752
Sponsor's protocol ID
YL202-INT-101-01
Status last verified
May 2026
First submitted
1 Dec 2022
Last updated
15 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing YL202 in people with Non Small Cell Lung Cancer and Breast Cancer, run by MediLink Therapeutics (Suzhou) Co., Ltd. at 13 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 31 inclusion and 41 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: under way, not looking for participants, as of the sponsor's last update on 15 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evaluate the occurrence of DLTs during the first cycle (time frame: At the end of Cycle 1 (each cycle is 21 days)). 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 NCT05653752.

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 15 May 2026.

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