The Efficacy and Safety of Penpulimab in the Treatment of Metastatic PPGL Patients Who Fail to Other Systemic Treatment

NCT05885399 | Unknown Phase 2

• 1 other identifier: 06086-06
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

Metastatic pheochromocytoma / paraganglioma (MPP) are rare while the prognosis was poor. Penpulimab is specifically an immune check-point inhibitor of PD1 and has been approved for the treatment of several malignancies.This phase II trial studies the efficacy and safety of penpulimab in the treatment of MPP patients who fail to other systemic therapy.

Conditions

Pheochromocytoma, Metastatic; Pheochromocytoma Malignant; Paraganglioma, Malignant

Outcome Measures

Primary Outcomes (2)

• The objective response rate (ORR)

  Defined for all patients whose tumor met the criteria of Complete Response (CR)and Partial Response (PR)

  At the end of Cycle 3(each cycle is 21 days)

• The disease control rate (DCR)

  Defined for all patients whose tumor met the criteria of CR or PR or stable disease(SD)

  At the end of Cycle 3(each cycle is 21 days)

Secondary Outcomes (3)

• progression-free survival (PFS)

  At least 1 cycle(each cycle is 21 days)

• biochemical response

  At the end of Cycle 3 (each cycle is 21 days)

• Incidence of adverse events

  At the end of Cycle 1 (each cycle is 21 days)

Study Arms (1)

penpulimab

EXPERIMENTAL

Penpulimab will be administered intravenously at a dose of 200 mg every 3 weeks. Treatment continued until the patient exhibited radiographic or clinical disease progression or unacceptable adverse events.

Drug: Penpulimab

Interventions

Penpulimab DRUG

Penpulimab will be administered intravenously at a dose of 200 mg every 3 weeks. Treatment continued until the patient exhibited radiographic or clinical disease progression or unacceptable adverse events.

penpulimab

Eligibility Criteria

• Age: 15 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Provide written informed consent.
• Age 18-75 years old
• Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2.
• Patients with histologically or radiologically confirmed MPP and fail to other systemic therapy.
• Estimated life expectancy longer than 6 months.
• Confirmed non-pregnancy and lactation. During the entire study period and within 6 months after the last administration, the subjects and their spouses are willing to use efficient contraceptive measures.
• Laboratory requirements:
• Absolute granulocyte count (AGC) greater than 1.5 x 109/L;
• Platelet count greater than 80 x 109/L;
• Hemoglobin greater than 90g/L;
• Serum bilirubin less than 1.5 x upper limit of normal (ULN);
• )Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than 2.5 x ULN;
• Serum creatinine less than 1.5 x ULN or creatinine clearance (CCr)≥60ml/min;
• Doppler ultrasound assessment: left ventricular ejection fraction (LVEF) ≥ lower limit of normal value (50%).

You may not qualify if:

• Patients who had been previously treated with anti-PD1, anti-PD-L1, or anti-PD-L2 medications were excluded from this trial.
• Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 14 days prior to the first dose of trial treatment.
• Has a known history of active TB (Bacillus Tuberculosis).
• Has a known history of Human Immunodeficiency Virus (HIV).
• Has known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA \[qualitative\] is detected).
• Has an active infection requiring systemic therapy.
• Didn't meet eligibility for organ function.
• Abnormal coagulation (INR \>1.5 or prothrombin time (PT) \> ULN 4 seconds or APTT \>1.5 ULN), bleeding tendency or being treated with thrombolytic or anticoagulant therapy.
• Uncontrolled congestive heart failure .

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, China

RECRUITING

MeSH Terms

Conditions

Pheochromocytoma; Neoplasm Metastasis; Paraganglioma, Extra-Adrenal

Interventions

penpulimab

Condition Hierarchy (Ancestors)

Paraganglioma; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Anli Tong

  Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anli Tong

CONTACT

13911413589; tonganli@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2023
• First Posted: June 2, 2023
• Study Start: April 1, 2023
• Primary Completion: March 1, 2025
• Study Completion: March 1, 2025
• Last Updated: June 2, 2023

Record last verified: 2023-05

Locations

CN (1)