A Study of PLB-002 in Advanced Solid Tumors

NCT07304128 | Recruiting Phase 1 FDA Drug

• 1 other identifier: PLB-002-001
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Advanced Solid Tumor

Keywords

PLB-002; ovarian cancer; NSCLC; CLDN6; claudin6

Outcome Measures

Primary Outcomes (2)

• Recommended Extension Dose and Recommended Phase 2 Dose (RP2D)

  Based on the maximum tolerated dose, cumulative safety, and pharmacokinetic data

  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

  up to 2 years

Secondary Outcomes (14)

• Maximum Serum Concentration of PLB-002 (Cmax)

  21 days

• Time of Maximum Serum Concentration of PLB-002(Tmax)

  21 days

• Area under the Serum Concentration-Time curve from the time of dosing to the last measurable concentration (AUClast) for PLB-002

  21 days

• Area under the Serum Concentration-Time curve from the time of dosing extrapolated to time infinity (AUCinf) for PLB-002

  84 days

• Terminal Half-life (t1/2) of Serum PLB-002

  84 days

Study Arms (2)

Part 2: Dose Expansion Study

EXPERIMENTAL

Patients with CLDN6 expression

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.

Drug: PLB-002

Interventions

PLB-002 DRUG

antibody drug conjugate (ADC)

Part 1: Dose Escalation Study; Part 2: Dose Expansion Study

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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);

Sponsors & Collaborators

• Primelink BioTherapeitics(ShenZhen) Limited: lead

Study Sites (2)

Fudan University Shanghai Cancer Center- Gynecology Onc

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

Fudan University Shanghai Cancer Center- Phase 1

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

MeSH Terms

Conditions

Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Central Study Contacts

Yi Xu

CONTACT

+86 18556849425; yi.xu@primelinkbio.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2025
• First Posted: December 26, 2025
• Study Start: February 6, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): December 30, 2027
• Last Updated: March 3, 2026

Record last verified: 2026-02

Locations

CN (2)