NCT05576961View on ClinicalTrials.gov

Safety and Efficacy of RX-af01 Combined With PD-1 Antibody

PHASE1/PHASE2RecruitingINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

September 15, 2022

Primary Completion Date

December 31, 2024

Study Completion Date

December 31, 2024

Conditions
Solid TumorImmune Checkpoint InhibitorIntestinal Flora
Interventions
DRUG

RX-af01

Pretreatment： vancomycin: 125mg po, tid, D-6 to D-3 RX-af01: 2 capsules, bid, po, D-2 to D0 Treatment (Every 3 weeks) RX-af01: 1 capsule, bid, po, every day Toripalimab: 240mg, ivdrip, D1, every 3 weeks.

DRUG

Mixed bacteria

Pretreatment： vancomycin: 125mg po, tid, D-5 to D-3

DRUG

High dose RX-af01

Pretreatment： vancomycin: 125mg po, tid, D-5 to D-3

Trial Locations (1)

510060

RECRUITING

Miao-Zhen Qiu, Guangzhou

All Listed Sponsors
lead

Sun Yat-sen University

OTHER