Actively Recruiting
A Study of PLB-002 in Advanced Solid Tumors
Led by Primelink BioTherapeitics(ShenZhen) Limited · Updated on 2026-03-03
100
Participants Needed
2
Research Sites
98 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
A Study of PLB-002 in Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ability to understand and voluntarily sign informed consent before any study procedure
- Adults aged 18 years or older
- Histologically or cytologically confirmed advanced solid tumors, including platinum-resistant ovarian cancer, NSCLC, testicular cancer, or other solid tumors, with no effective standard treatment or failure/intolerance to standard therapy
- At least one measurable lesion according to RECIST 1.1 criteria
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Expected survival of 3 months or longer
- For Part 1, available archived or fresh tissue for retrospective CLDN6 evaluation; for Part 2, positive CLDN6 staining of tumor tissue by immunohistochemistry
- Adequate organ function as shown by specified blood counts, liver and kidney function, coagulation, and cardiac function
- Female participants must have negative pregnancy test, not be breastfeeding, and agree to effective contraception if of childbearing potential; or be postmenopausal or surgically sterile
- Male participants must have had vasectomy or agree to use effective contraception and avoid sperm donation up to 6 months after last dose
You will not qualify if you...
- Received systemic chemotherapy, targeted therapy, hormone therapy, or herbal anti-cancer medication within 2 weeks before study drug; or biological anti-cancer products within 4 weeks or 5 half-lives (whichever shorter); or cytotoxic agents with major delayed toxicity within 6 weeks
- Underwent radical radiotherapy within 4 weeks, stereotactic or whole brain radiotherapy within 4 weeks, palliative radiotherapy within 2 weeks, or radioactive drug treatment within 8 weeks before study drug
- Prior anti-cancer therapies targeting CLDN6
- Persistent toxicity greater than grade 1 from prior anti-cancer therapy except manageable alopecia or endocrine dysfunction
- Active or uncontrolled infections needing systemic antibiotics, antivirals, or antifungals within 2 weeks
- Meningeal metastases or symptomatic/uncontrolled brain metastases or spinal cord compression; asymptomatic brain metastases allowed if treated, stable, and off high-dose steroids for 4 weeks
- Uncontrolled pleural, peritoneal, or pericardial effusion unless stable and asymptomatic
- Other malignancies requiring treatment within 5 years except certain treated cancers with no relapse
- History of active or chronic corneal, conjunctival, or ocular surface diseases affecting monitoring
- Pre-existing significant lung diseases with symptoms or requiring treatment
- Severe or unstable cardiac conditions including specific heart failure, arrhythmias, recent myocardial infarction, or QT prolongation
- History of cerebrovascular diseases within 6 months
- Uncontrolled hypertension or diabetes despite treatment
- Active hepatitis B or C infection above specified viral loads
- Known HIV infection or AIDS
- Major surgery within 2 weeks before first dose
- Participation in another investigational clinical study within 28 days or 5 half-lives before first dose
- Known hypersensitivity to study drug components including eribulin
- Pregnant or breastfeeding women
- Any other clinically significant condition that could risk safety or interfere with study participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Fudan University Shanghai Cancer Center- Gynecology Onc
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
2
Fudan University Shanghai Cancer Center- Phase 1
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
Research Team
Y
Yi Xu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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