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Intrathecal Dual Checkpoint Inhibitor (PD-1 and CTLA-4) in Combination With Pemetrexed for Leptomeningeal Metastasis
Sponsor: Guangzhou Medical University
Summary
This phase I/II study is to evaluate the recommended dose, safety, feasibility, and therapeutic response of intrathecal dual checkpoint inhibitor (targeting PD-1 and CTLA-4 with QL1706) in combination with pemetrexed in patients with leptomeningeal metastasis.
Official title: Intrathecal Administration of Dual Checkpoint Inhibitor in Combination With Pemetrexed in Patients With Leptomeningeal Metastasis: a Phase I/II Study
Key Details
Gender
All
Age Range
21 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
34
Start Date
2025-03-17
Completion Date
2026-07-01
Last Updated
2025-05-18
Healthy Volunteers
No
Interventions
QL1706 (bispecific antibody targeting PD-1 and CLTA-4)
Intrathecal injection of PD-1/CTLA-4 bispecific antibody was administered every 2 weeks for 6 weeks during the induction phase, followed by monthly injections during the maintenance phase, until recurrence or death.
Pemetrexed (Alimta)
Pemetrexed (Alimta, Eli Lilly and Company) was administrated by intrathecal injection, first as induction therapy, twice per week for 2 weeks, followed by consolidation therapy, once per week for 4 weeks, then maintenance therapy, once per month until the patient's death, leptomeningeal metastasis progresses, or intolerable severe adverse events occurred.
Locations (2)
The Affiliated Huizhou Hospital, Guangzhou Medical University
Huizhou, Guangdong, China
The Affiliated Huizhou Hospital, Guangzhou Medical University
Huizhou, Guangdong, China