Advanced Solid TumorPhase 1NCT07304128
A Study of PLB-002 in Advanced Solid Tumors
A Phase 1 study testing PLB-002 in people with Advanced Solid Tumor, run by Primelink BioTherapeitics(ShenZhen) Limited at 2 sites in China.
Trial summary
This study will test the safety, including side effects, and determine the characteristics of a drug called PLB-002 in participants with 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?
- PLB-002
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesChina
- Study dates
- 6 Feb 2026to 30 Dec 2027
- 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 who meet all of the following criteria will be eligible to participate in the study:
- 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.
- Adults aged 18 years or older.
- 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.
- At least one measurable lesion as per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria.
- Performance status of Eastern Cooperative Oncology Group (ECOG) 0-1.
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- Expected survival of 3 months or longer.
- 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.
- 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%
- 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).
- 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.
Who cannot join
- Patients who meet any of the following criteria will be excluded from participation in the study:
- 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.
- 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.
- Patient has received any other anti-cancer therapies targeting at CLDN6.
- 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.
- Patient has active or uncontrolled infections, which require systemic treatment of antibiotics, antivirals, or antifungals, within 2 weeks prior to start of study drug.
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- 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.
- 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.
- 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.
- 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.
- 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.
- 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).
- Patient with history of cerebrovascular diseases (including but not limited to stroke or transient ischemic attack) within 6 months prior to the first dose.
- Patient with uncontrolled hypertension (systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 100 mmHg despite treatment), or uncontrolled diabetes despite treatment.
- 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.
- 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.
- Patient with known history of human immunodeficiency virus (HIV) infection and/or acquired immunodeficiency syndrome.
- Patient has major surgery within 2 weeks of first dose of study drug.
- 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.
- Patient with a known history of hypersensitivity to any components of the study drug, including eribulin and excipients.
- Pregnant or breastfeeding women.
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
Fudan University Shanghai Cancer Center- Gynecology Onc
Shanghai, Shanghai Municipality, 200032
Xiaohua Wu, MD, wu.xh@fudan.edu.cn
- Recruiting
Fudan University Shanghai Cancer Center- Phase 1
Shanghai, Shanghai Municipality, 200032
Jian Zhang, MD, syner20000@163.com
About this study
Official title: 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
This study will test the safety, including side effects, and determine the characteristics of a drug called PLB-002 in participants with solid tumors.
- Conditions
- Advanced Solid Tumor
- Being tested
- PLB-002
- Keywords
- PLB-002, ovarian cancer, NSCLC, CLDN6, claudin6
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PLB-002Drug
antibody drug conjugate (ADC)
| Study group | Role | What they receive |
|---|---|---|
| Part 2: Dose Expansion Study | Experimental | Patients with CLDN6 expression Receives: Drug: PLB-002 |
| Part 1: Dose Escalation Study | Experimental | In the dose escalation part of the study, patients with advanced solid tumors will be treated with escalating doses of PLB-002. Receives: Drug: PLB-002 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recommended Extension Dose and Recommended Phase 2 Dose (RP2D)
Based on the maximum tolerated dose, cumulative safety, and pharmacokinetic data
Measured: up to 2 years
Incidence and severity of adverse events and serious adverse events
Number and percentage of patients with adverse events (AEs), serious adverse events (SAEs), treatment-related adverse events (TRAEs), and dose-limiting toxicities (DLTs) ,according to NCI-CTCAE Version 5.0
Measured: up to 2 years
Secondary outcomes (14)
Maximum Serum Concentration of PLB-002 (Cmax)
PK assessment
Measured: 21 days
Time of Maximum Serum Concentration of PLB-002(Tmax)
PK assessment
Measured: 21 days
Area under the Serum Concentration-Time curve from the time of dosing to the last measurable concentration (AUClast) for PLB-002
PK assessment
Measured: 21 days
Area under the Serum Concentration-Time curve from the time of dosing extrapolated to time infinity (AUCinf) for PLB-002
PK Assessment
Measured: 84 days
Terminal Half-life (t1/2) of Serum PLB-002
PK Assessment
Measured: 84 days
Apparent volume of distribution during the terminal phase (Vz) of PLB-002
PK assessment
Measured: 84 days
Clearance (CL) of PLB--002
PK Assessment
Measured: 84 days
Number of anti-drug antibody (ADA) Positive Participants
Immunogenicity will be measured by the number of participants that are ADA positive.
Measured: up to 2 years
QTc assessment (only applicable for Part 1)
To evaluate the effect of different concentrations of PLB-002 on the QTc interval
Measured: up to 2 years
Objective Response Rate (ORR)
Percentage of participants with best response of complete response (CR) or partial response (PR) according to RECIST 1.1
Measured: up to 2 years
Duration of Response (DOR)
Time from CR or PR to objective disease progression or death to any cause
Measured: up to 2 years
Disease control rate (DCR)
Disease control rate (DCR) refers to the percentage of patients achieving CR, PR or SD among all evaluable cases per RECIST v1.1.
Measured: up to 2 years
Progression Free Survival (PFS)
PFS is defined as the time from the start of the treatment until objective disease progression or death from any cause
Measured: up to 2 years
Overall Survival
To assess Overall survival (OS) (only applicable for Part 2)
Measured: up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2025
- Study start6 Feb 2026
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Primelink BioTherapeitics(ShenZhen) Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07304128
- Sponsor's protocol ID
- PLB-002-001
- Status last verified
- Feb 2026
- First submitted
- 1 Dec 2025
- Last updated
- 3 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07304128
- Acronym / sponsor ID
- PLB-002-001
- Conditions
- Advanced Solid Tumor
- Keywords
- PLB-002, ovarian cancer, NSCLC, CLDN6, claudin6
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Primelink BioTherapeitics(ShenZhen) LimitedIndustry (pharma, biotech, devices)
- Study start
- 6 Feb 2026 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 26 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will test the safety, including side effects, and determine the characteristics of a drug called PLB-002 in participants with solid tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part 2: Dose Expansion Study | Experimental | Drug: PLB-002Patients with CLDN6 expression |
| Part 1: Dose Escalation Study | Experimental | Drug: PLB-002In the dose escalation part of the study, patients with advanced solid tumors will be treated with escalating doses of PLB-002. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Patients who meet all of the following criteria will be eligible to participate in the study:
- 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%
Key exclusion criteria (28 listed)
- Patients who meet any of the following criteria will be excluded from participation in the study:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PLB-002antibody drug conjugate (ADC) | Drug | Part 1: Dose Escalation Study, Part 2: Dose Expansion Study |
Primary outcome
Recommended Extension Dose and Recommended Phase 2 Dose (RP2D)
Time frame: up to 2 years
Based on the maximum tolerated dose, cumulative safety, and pharmacokinetic data
Incidence and severity of adverse events and serious adverse events
Time frame: up to 2 years
Number and percentage of patients with adverse events (AEs), serious adverse events (SAEs), treatment-related adverse events (TRAEs), and dose-limiting toxicities (DLTs) ,according to NCI-CTCAE Version 5.0
14 secondary outcomes
Maximum Serum Concentration of PLB-002 (Cmax)
Time frame: 21 days
Time of Maximum Serum Concentration of PLB-002(Tmax)
Time frame: 21 days
Area under the Serum Concentration-Time curve from the time of dosing to the last measurable concentration (AUClast) for PLB-002
Time frame: 21 days
Area under the Serum Concentration-Time curve from the time of dosing extrapolated to time infinity (AUCinf) for PLB-002
Time frame: 84 days
Terminal Half-life (t1/2) of Serum PLB-002
Time frame: 84 days
Apparent volume of distribution during the terminal phase (Vz) of PLB-002
Time frame: 84 days
Clearance (CL) of PLB--002
Time frame: 84 days
Number of anti-drug antibody (ADA) Positive Participants
Time frame: up to 2 years
QTc assessment (only applicable for Part 1)
Time frame: up to 2 years
Objective Response Rate (ORR)
Time frame: up to 2 years
Duration of Response (DOR)
Time frame: up to 2 years
Disease control rate (DCR)
Time frame: up to 2 years
Progression Free Survival (PFS)
Time frame: up to 2 years
Overall Survival
Time frame: up to 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PLB-002 in people with Advanced Solid Tumor, run by Primelink BioTherapeitics(ShenZhen) Limited at 2 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 15 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 3 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 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 Yi Xu (+86 18556849425, yi.xu@primelinkbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recommended Extension Dose and Recommended Phase 2 Dose (RP2D) (time frame: up to 2 years). 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?
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 3 Mar 2026.