Actively Recruiting
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
Led by Primelink BioTherapeitics(ShenZhen) Limited · Updated on 2026-03-03
100
Participants Needed
2
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and characteristics of a drug called PLB-002 in adults with advanced solid tumors. This phase 1 study focuses on participants with tumors that express CLDN6. The goal is to find a safe dose and understand side effects for patients who have not responded to standard treatments or have no available standard options. The study includes two parts a dose escalation phase where increasing doses of PLB-002 are tested on patients with advanced solid tumors, and a dose expansion phase focusing on patients with positive CLDN6 tumor staining. PLB-002 is an antibody drug conjugate ADC given to participants in these phases to assess how the body processes the drug and to monitor safety. Participants will undergo evaluations for tumor response, side effects, blood and organ function tests, and measurements of drug levels in the blood. The study will track outcomes such as recommended doses, adverse events, tumor control, and survival over up to two years. Patients will be monitored regularly to assess treatment effects and safety throughout the trial period.
CONDITIONS
Brief 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 a written informed consent form
- 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 that failed or are intolerant to standard therapy
- At least one measurable lesion per RECIST 1.1 criteria
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
- Expected survival of 3 months or longer
- Availability of tumor tissue for CLDN6 evaluation; positive CLDN6 staining required for dose expansion phase
- Adequate organ function based on laboratory tests
- Female participants must have a negative pregnancy test if of childbearing potential and agree to contraception, or be postmenopausal or surgically sterile
- Male participants must have undergone vasectomy or agree to use contraception and avoid sperm donation during the study and 6 months after
You will not qualify if you...
- Recent systemic chemotherapy, targeted therapy, hormone therapy, or herbal anti-cancer medications within specified washout periods
- Recent radiotherapy or radioactive drug treatments within specified timeframes
- Previous anti-cancer therapies targeting CLDN6
- Persistent toxicity greater than Grade 1 from prior cancer treatments (except manageable alopecia or endocrine dysfunction)
- Active or uncontrolled infections requiring systemic treatment within 2 weeks prior to study
- Meningeal metastases or symptomatic/uncontrolled brain metastases or spinal cord compression
- Uncontrolled pleural, peritoneal, or pericardial effusion unless stable and asymptomatic
- Other malignancies needing treatment within 5 years except certain treated cancers with favorable prognosis
- Active or chronic ocular diseases affecting monitoring
- Significant lung diseases requiring treatment
- Severe or unstable cardiac conditions including recent heart failure, arrhythmias, or QT prolongation risks
- Recent cerebrovascular disease within 6 months
- Uncontrolled hypertension or diabetes despite treatment
- Active hepatitis B or C infection
- Known HIV infection
- Major surgery within 2 weeks of first study dose
- Participation in another investigational study within specified washout
- Hypersensitivity to study drug components
- Pregnant or breastfeeding women
- Any other condition posing risk to safety or study completion per investigator judgment
Research Team
Y
Yi Xu
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