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NCT06809530 | RECRUITING | Leptomeningeal Metastasis

Intrathecal Double Checkpoint Inhibition in Combination with Pemetrexed
Sponsor:

Z is very much with pan

Information provided by (Responsible Party):

Z is very much with pan

Brief Summary:

The objective of the present study is to evaluate the tolerability, feasibility, safety and therapeutic response of intrathecal administration of double checkpoint inhibition(QL1706) in combination with pemetrexed in patients with leptomeningeal metastasis.

Condition or disease

Leptomeningeal Metastasis

Intervention/treatment

QL1706 (bispecific antibody targeting PD-1 and CLTA-4)

Pemetrexed (Alimta)

Phase

PHASE1

PHASE2

Detailed Description:

Previous studies have demonstrated that combining PD-1 monoclonal antibody immunotherapy with intrathecal pemetrexed is both safe and effective. The treatment regimen within the IT-P-QL1706 study consists of intrathecal administration of iparomlimab and tuvonralimab (QL1706) in combination with intrathecal pemetrexed.

Study Type : INTERVENTIONAL
Estimated Enrollment : 34 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : Intrathecal Administration of Double Checkpoint Inhibition in Combination with Pemetrexed in Patients with Leptomeningeal Metastasis: a Monocentric Phase I/II
Actual Study Start Date : 2025-09-01
Estimated Primary Completion Date : 2026-06-01
Estimated Study Completion Date : 2026-07-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 21 Years to 75 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • 1. Histologically or cytologically confirmed diagnosis of solid tumors; Cerebrospinal fluid cytopathology is positive.
  • 2. Male or female aged between 21 and 75 years; Normal liver and kidney function; WBC≥4000/mm3, Plt≥100000/mm3.
  • 3. No history of severe nervous system disease; No severe dyscrasia.
Exclusion Criteria
  • 1. Any evidence of nervous system failure, including severe encephalopathy, grade 3 or 4 leukoencephalopathy on imaging, and Glasgow Coma Score less than 11.
  • 2. Any evidence of extensive and lethal progressive systemic diseases without effective treatment.
  • 3. A history of HIV or AIDS, acute or chronic hepatitis B or C infection, previous anti-PD1 therapy-induced pneumonitis, or have ongoing \>Grade 2 adverse events of such therapy; or ongoing autoimmune disease that required systemic treatment in the past 2 years.
  • 4. Patients with poor compliance or other reasons that were unsuitable for this study.
Intrathecal Double Checkpoint Inhibition in Combination with Pemetrexed

Location Details

NCT06809530

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Locations

RECRUITING

China, Guangdong

The Affiliated Huizhou Hospital, Guangzhou Medical University

Huizhou, Guangdong, China, 516000

RECRUITING

China, Guangdong

The Affiliated Huizhou Hospital, Guangzhou Medical University

Huizhou, Guangdong, China, 516000