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RECRUITING
NCT06809530
PHASE1/PHASE2

Intrathecal Dual Checkpoint Inhibitor (PD-1 and CTLA-4) in Combination With Pemetrexed for Leptomeningeal Metastasis

Sponsor: Guangzhou Medical University

View on ClinicalTrials.gov

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

DRUG

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.

DRUG

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