Skip to main content
TTrialFinderData
TrialFinderData is for informational purposes only and does not provide medical advice. Always talk to your doctor.

Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 1INTERVENTIONAL

A Study of PLB-002 in Advanced Solid Tumors

A Phase 1, Open-Label, Multi-Center, Dose Escalation and Expansion Study of PLB-002 (Anti-Claudin 6 ADC) in Adults With Advanced Solid Tumors

A Study of PLB-002 in Advanced Solid Tumors (NCT07304128) is a Phase 1 interventional studying Advanced Solid Tumor, sponsored by Primelink BioTherapeitics(ShenZhen) Limited. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

This study will test the safety, including side effects, and determine the characteristics of a drug called PLB-002 in participants with solid tumors.

What Stage of Research Is This?

Phase 1 trials test a new treatment for the first time in humans, focusing on safety, dosing, and how the body processes the drug. For Advanced Solid Tumor, a Phase 1 study typically enrolls a small number of participants — often healthy volunteers or patients who have exhausted standard treatment options. Phase 1 results determine whether a treatment moves into larger Phase 2 efficacy studies.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 100 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Advanced Solid Tumor subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: - Patients who meet all of the following criteria will be eligible to participate in the study: 1. Patient must have the ability to understand and voluntarily sign a written willing to sign a consent form form (ICF) and must have signed ICF prior to any study procedure. 2. Adults aged 18 years or older. 3. diagnosed by tissue sample (biopsy-confirmed) advanced solid tumors, including platinum-resistant ovarian cancer (including fallopian tube and primary peritoneal carcinoma), NSCLC, testicular cancer, and other solid tumors, who have failed or intolerant to available standard-of-care therapy or no standard treatment exists. 4. At least one measurable lesion as per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria. 5. Performance status of Eastern Cooperative Oncology Group (ECOG) 0-1. 6. Expected survival of 3 months or longer. 7. Part 1: Available archived or fresh tissue for retrospective CLDN6 evaluation (patients in the backfill part are recommended to have positive CLDN6 staining results by immunohistochemistry \[IHC\] tested in the central laboratory before enrollment); Part 2: Positive CLDN6 staining of tumor tissue (archived or fresh) by IHC tested in the central laboratory. 8. Have your organs (liver, kidneys, etc.) are working well enough based on blood tests, as indicated by the following laboratory parameters in below table. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * Patients who meet all of the following criteria will be eligible to participate in the study: 1. Patient must have the ability to understand and voluntarily sign a written informed consent form (ICF) and must have signed ICF prior to any study procedure. 2. Adults aged 18 years or older. 3. Histologically or cytologically confirmed advanced solid tumors, including platinum-resistant ovarian cancer (including fallopian tube and primary peritoneal carcinoma), NSCLC, testicular cancer, and other solid tumors, who have failed or intolerant to available standard-of-care therapy or no standard treatment exists. 4. At least one measurable lesion as per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria. 5. Performance status of Eastern Cooperative Oncology Group (ECOG) 0-1. 6. Expected survival of 3 months or longer. 7. Part 1: Available archived or fresh tissue for retrospective CLDN6 evaluation (patients in the backfill part are recommended to have positive CLDN6 staining results by immunohistochemistry \[IHC\] tested in the central laboratory before enrollment); Part 2: Positive CLDN6 staining of tumor tissue (archived or fresh) by IHC tested in the central laboratory. 8. Have adequate organ function, as indicated by the following laboratory parameters in below table. Hematologic (no transfusion or hematopoietic stimulating factor treatment within 14 days) Neutrophils ≥ 1.5 × 109/L Platelets ≥ 100× 109/L Hemoglobin ≥ 90 g/L Hepatic function Total bilirubin ≤ 1.5×ULN (≤ 3.0×ULN for patients with Gilbert's syndrome or liver metastasis/ hepatocellular carcinoma) Alanine aminotransferase (ALT) ≤ 2.5×ULN (≤ 5.0×ULN for patients with liver metastasis/ hepatocellular carcinoma) Aspartate aminotransferase (AST) ≤ 2.5×ULN (≤ 5.0×ULN for patients with liver metastasis/ hepatocellular carcinoma) Albumin ≥ 3.0 g/dL Renal function Creatinine clearance (Ccr) ≥ 60 mL/min (Ccr calculated according to Cockcroft-Gault formula) Coagulation function Activated partial thromboplastin time (aPTT), international normalized ratio (INR) and prothrombin time ≤ 1.5 × ULN (If patients are receiving anticoagulant therapy: stable doses of anticoagulants must be taken for ≥ 1 month, and the prothrombin time/aPTT/INR must be within the intended therapeutic range) Cardiac function Left ventricular ejection fraction (LVEF) ≥ 50% 9. Female patients should meet at least 1 of the following criteria before they can participate in the study: * Women of childbearing potential (WOCBP) must have a negative serum pregnancy test during the screening period (within 7 days prior to the first dose of the study drug), must not be lactating, and must be willing to practice a highly effective contraceptive method throughout the study (i.e., from study entry up to 6 months after the last dose of the study drug). * Females who have no childbearing potential (i.e., physiologically incapable of pregnancy), including those who have undergone hysterectomy, bilateral oophorectomy, or bilateral salpingectomy. * Postmenopausal (total cessation of menses for ≥ 1 year). 10. Male patients are eligible to participate in the study if they have undergone a vasectomy or agree to use a highly effective method of contraception and refrain from donating sperm from study entry up to 6 months after the last dose of the study drug. Exclusion Criteria: * Patients who meet any of the following criteria will be excluded from participation in the study: 1. Patient received systemic chemotherapy, small molecular target therapy, hormone therapy, or herbal medication with anti-cancer indication within 2 weeks prior to start of study drug; or received biological anti-cancer products (such as antibody, antibody-drug conjugate \[ADC\]) within 4 weeks or 5 half-life time prior to start of study drug (whichever is shorter). For cytotoxic agents with major delayed toxicity (such as nitrosourea or mitomycin C), 6 weeks of washout are mandated. 2. Patients who have undergone radical radiotherapy within 4 weeks prior to the first dose of study drug, or have undergone brain stereotactic radiotherapy or whole brain radiotherapy within 4 weeks prior to the first dose of study drug, or have undergone palliative radiotherapy within 2 weeks prior to the first dose of study drug, or have used a radioactive drug (Strontium, Samarium, etc.) within 8 weeks prior to the first dose of the study drug. 3. Patient has received any other anti-cancer therapies targeting at CLDN6. 4. Patient has persisting toxicity of \> Grade 1 (NCI CTCAE v5.0) relating to prior anti-cancer therapy with the exceptions of alopecia and endocrine dysfunction which could be managed by replacement therapy. 5. Patient has active or uncontrolled infections, which require systemic treatment of antibiotics, antivirals, or antifungals, within 2 weeks prior to start of study drug. 6. Patient has meningeal metastases (symptomatic or asymptomatic), or has symptomatic or uncontrolled brain metastases or spinal cord compression. Patients with asymptomatic brain metastases (longest diameter of brain lesion ≤ 3 cm) can be enrolled only if treated, non-progressive brain metastases and off high-dose steroids (\> 20 mg prednisone or equivalent) for at least 4 weeks. If the patient has previously received antiepileptic treatment for central nervous system (CNS) metastases, antiepileptic medications should be discontinued for at least 2 weeks (14 days) prior to start of study drug. 7. Patient has uncontrolled pleural, peritoneal or pericardial effusion. Asymptomatic and stable effusion could be enrolled if any one of the following criteria is met: * If previous imaging indicated the presence of effusion, subsequent imaging shows a reduction, no change, or a slight increase of the effusion volume, and the patient has no effusion related symptom. * If puncture drainage or other therapy was performed, reexamination after an interval of 2 weeks at least shows no significant increase of the effusion volume, and the patient has no effusion related symptom. 8. Patients who have other malignancies requiring treatment within 5 years prior to the first dose of study drug will be excluded, except for radically treated locally curable basal or squamous cell skin cancer, cervical carcinoma in situ, papillary thyroid carcinoma, breast ductal carcinoma in situ and other malignancies with favorable prognosis that have been treated with no relapse within 5 years. 9. Patients with history of active or chronic corneal and conjunctival diseases; or history of active ocular surface diseases or scarring conjunctivitis; or presence of other clinically significant ocular diseases affecting corneal, conjunctival, or other areas that may impact drug-related ophthalmic toxicity monitoring. 10. Has a pre-existing clinically significant lung diseases (e.g., interstitial lung disease, non-infectious pneumonitis, pulmonary fibrosis, and severe radiation pneumonitis), with abnormal signs or symptoms, or require treatment. 11. Patient has severe or unstable cardiac conditions, including: * History of congestive heart failure (New York Heart Association Class \> 2); * History of unstable angina or myocardial infarction within 6 months prior to the first dose of study drug; * History of atrial fibrillation, supraventricular arrhythmia, or ventricular arrhythmia within 6 months prior to the first dose of study drug and still in unstable condition and requiring treatment or intervention; * QTcF prolongation \>470 ms, or risk factors for Torsades de Pointes (such as congenital long QT syndrome, family history of long QT syndrome, unexplained sudden death under the age of 40 years old in first-degree relatives, severe hypokalemia or hypomagnesemia, concomitant use of medication which has known risk of QT prolongation). 12. Patient with history of cerebrovascular diseases (including but not limited to stroke or transient ischemic attack) within 6 months prior to the first dose. 13. Patient with uncontrolled hypertension (systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 100 mmHg despite treatment), or uncontrolled diabetes despite treatment. 14. Patient with active hepatitis B virus (HBV) infection, defined as positive hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb), and HBV deoxyribonucleic acid (DNA) levels higher than 200 IU/mL or 1000 copies/mL. 15. Patient with active hepatitis C virus (HCV) infection, defined as positive hepatitis C antibody (HCV-Ab) and HCV-ribonucleic acid (RNA) quantified above the upper limit of the normal detection units. 16. Patient with known history of human immunodeficiency virus (HIV) infection and/or acquired immunodeficiency syndrome. 17. Patient has major surgery within 2 weeks of first dose of study drug. 18. Participation in another clinical study with an investigational product administered within 28 days or 5 half-lives (whichever is shorter) prior to receiving the first dose of study drug. 19. Patient with a known history of hypersensitivity to any components of the study drug, including eribulin and excipients. 20. Pregnant or breastfeeding women. 21. Patient with history or evidence of any other clinically significant condition or disease that, in the opinion of the investigator, would be a risk to patient's safety or interfere with the study evaluation, procedures or completion.

Treatments Being Tested

DRUG

PLB-002

antibody drug conjugate (ADC)

Locations (2)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Fudan University Shanghai Cancer Center- Gynecology Onc
Shanghai, Shanghai Municipality, China
Fudan University Shanghai Cancer Center- Phase 1
Shanghai, Shanghai Municipality, China

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT07304128), the sponsor (Primelink BioTherapeitics(ShenZhen) Limited), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT07304128 clinical trial studying?

This study will test the safety, including side effects, and determine the characteristics of a drug called PLB-002 in participants with solid tumors. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT07304128?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT07304128?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT07304128. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT07304128. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.