Safety and Efficacy of Pucotenlimab in pLECC

NCT06969534 | Recruiting Phase 2

• 1 other identifier: PLECC-1001
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

Lymphoepithelioma-like carcinoma (LELC) in children is a rare epithelial malignant tumor. Regarding pediatric lymphoepithelioma-like carcinoma (pLELC), its clinicopathological features, prognosis, and molecular characteristics remain unknown. In preclinical studies, this study aims to explore the safety and efficacy of the PD-1 monoclonal antibody pucotenlimab combined with the chemotherapy regimen of gemcitabine and cisplatin as the first-line treatment for lymphoepithelioma-like carcinoma in children and adolescents.

Conditions

Lymphoepithelioma-like Carcinoma; Lymphoepithelioma; Carcinoma

Outcome Measures

Primary Outcomes (1)

• PFS

  progression of the disease or the death

  PFS is defined as the time interval from the start of treatment until the occurrence of disease progression or death of the patient from any cause, whichever happens first (up to 24 months）.

Secondary Outcomes (2)

• ORR

  The objective response rate will be assessed over an estimated period of up to 3 months（after first 2 cycles, before the 3rd cycle, each cycle is 21 days).

• OS

  The assessment of OS will be carried out over an estimated period of up to 24 months.

Study Arms (1)

Pucotenlimab plus a fixed regimen( Gemcitabine and cisplatin)

EXPERIMENTAL

Drug: Pucotenlimab combined with GP regimen

Interventions

Pucotenlimab combined with GP regimen DRUG

A total of 33 cases are planned to be enrolled. All the subjects will receive Pucotenlimab (3mg/kg, on day 1, with a maximum dose not exceeding 200mg), administered once every 3 weeks (Q3W), and combined with the GP regimen. The chemotherapy is a fixed regimen, with Gemcitabine at a dose of 1g/m² on day 1 and day 8, and cisplatin at a dose of 80mg/m² on day 1. The chemotherapy will be given for 3 to 6 cycles, once every 3 weeks (Q3W).

Pucotenlimab plus a fixed regimen( Gemcitabine and cisplatin)

Eligibility Criteria

• Age: 1 Year - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Age: Between 1 and 18 years old;
• ECOG PS score: 0 to 1 point;
• Histopathologically confirmed locally advanced or metastatic lymphoepithelioma-like carcinoma in children or adolescents;
• Must have at least one measurable lesion defined by the RECIST or WHO criteria;
• Estimated survival time ≥ 6 months;
• Cardiac function:Left ventricular ejection fraction (LVEF) detected by echocardiography ≥ 50%; Electrocardiogram (EKG) shows no signs of myocardial ischemia;
• No history of arrhythmia requiring drug intervention before enrollment;
• No history of severe immune-related adverse events (CTCAE V4.03 Grade 3 or Grade 4);
• For patients known not to have bone marrow (BM) involvement:Absolute neutrophil count (ANC) ≥ 1.0×10⁹/L; Platelet count ≥ 100.0×10⁹/L;Hemoglobin ≥ 90 g/L;
• Liver and kidney functions should meet the following criteria: Total bilirubin (conjugated + unconjugated) ≤ 2.5× the upper limit of normal value (ULN) (corresponding to the age). Patients with confirmed Gilbert's syndrome can be considered for enrollment at the discretion of the investigator;Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5× ULN; Estimated glomerular filtration rate ≥ 30 mL/min/1.73 m² or serum creatinine (Cr) ≤ 1.5× ULN;
• During participation in the study, be able to comply with outpatient treatment, laboratory monitoring and necessary clinical visits;
• The parents/guardians of child or adolescent subjects are capable of understanding, consenting to and signing the Informed Consent Form (ICF) for the study and the applicable child consent form before any protocol-related procedures are initiated. With the consent of the parents/guardians, the subject is capable of expressing consent (when applicable).

You may not qualify if:

• Have received anti-PD-1 or anti-PD-L1 monoclonal antibodies or targeted drugs of related pathways;
• Known to be allergic to PD-1 monoclonal antibody or any of its excipients; Known to have a history of allergic diseases or have a severe allergic constitution;
• Have other malignant tumor diseases other than the tumor being treated in this study, except for: Malignant tumors that have been cured and have not recurred within 3 years before study enrollment, completely resected basal cell and squamous cell skin cancers, and any type of in-situ cancer that has been completely resected;
• Active central nervous system metastases (whether treated or not), including symptomatic brain metastases, meningeal metastases, spinal cord compression, etc.; Except for: Asymptomatic brain metastases (no progression within at least 4 weeks after radiotherapy and/or no neurological symptoms or signs after surgical resection, and no need for dexamethasone or mannitol treatment).
• Uncontrollable pleural effusion, pericardial effusion or ascites that requires repeated drainage;
• The toxicity of previous treatment is still \> Grade 1 (CTCAE V4.03 criteria), except for alopecia and neurotoxicity;
• Have a history of mental disorders;
• Have a history of drug abuse or drug addiction as determined by inquiry;
• Have a history of idiopathic pulmonary fibrosis or idiopathic pneumonia;
• Have comorbidities that require treatment with immunosuppressive drugs, or have comorbidities that require systemic or local use of corticosteroids at immunosuppressive doses (prednisone \> 10 mg/day or equivalent dose of similar drugs).
• Have a history of autoimmune diseases, including but not limited to systemic lupus erythematosus, psoriasis, rheumatoid arthritis, inflammatory bowel disease, Hashimoto's thyroiditis, etc., except for: Type 1 diabetes mellitus, hypothyroidism that can be controlled only by hormone replacement therapy, skin diseases that do not require systemic treatment (such as vitiligo, psoriasis), celiac disease that has been controlled, or diseases that are not expected to recur without external stimulating factors;
• Have a history of previous or current active tuberculosis infection;
• Have active infections that require systemic treatment;
• Uncontrolled hypertension (systolic blood pressure ≥ 140 mmHg and/or diastolic blood pressure ≥ 90 mmHg), or pulmonary hypertension, or unstable angina pectoris; Have had a myocardial infarction or undergone coronary artery bypass grafting or stenting surgery within 6 months before drug administration; Have a history of chronic heart failure meeting New York Heart Association (NYHA) criteria Class 3-4; Have clinically significant valvular heart disease; Have severe arrhythmias that require treatment (excluding atrial fibrillation and paroxysmal supraventricular tachycardia), including a QTc interval of ≥ 450 ms for men and ≥ 470 ms for women (calculated by the Fridericia formula); Have had a cerebrovascular accident (CVA) or transient ischemic attack (TIA) within 6 months before drug administration, etc.;
• Have severe medical comorbidities, including but not limited to: Uncontrolled diabetes mellitus, active peptic ulcer, active bleeding, etc.;

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Yizhuo Zhang

Guangzhou, Guangdong, 510060, China

RECRUITING

MeSH Terms

Conditions

Carcinoma

Condition Hierarchy (Ancestors)

Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Central Study Contacts

Yizhuo Zhang

CONTACT

020-87342460; zhangyzh@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of department of pediatric cancer,Principal Investigator,Clinical Professor,

Study Record Dates

• First Submitted: April 23, 2025
• First Posted: May 14, 2025
• Study Start: May 15, 2025
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): December 30, 2028
• Last Updated: May 15, 2025

Record last verified: 2025-05

Locations

CN (1)