A Phase I Study of SIM0505 in Participants With Advanced Solid Tumors

PHASE1RecruitingINTERVENTIONAL
Enrollment

414

Participants

Timeline

Start Date

February 26, 2025

Primary Completion Date

February 29, 2028

Study Completion Date

August 31, 2028

Conditions
Advanced Solid Tumors
Interventions
DRUG

SIM0505 for injection

Every 21 days is one cycle. Multiple dose levels of SIM0505 will be explored in dose escalation, and determine the maximum tolerated dose.

DRUG

SIM0505 for injection

Every 21 days is one cycle. 2-3 dose levels of SIM0505 will be explored in dose optimization, and determine the recommended dose (RD) of SIM0505 and evaluate the preliminary anti-tumor activity of SIM0505

Trial Locations (10)

32827

RECRUITING

Sarah Cannon Research Institute (SCRI) - Lake Nona, Orlando

37203

RECRUITING

Sarah Cannon Research Institute (SCRI) - Nashville, Nashville

78229

RECRUITING

UT Health San Antonio - Mays Cancer Center, San Antonio

100000

RECRUITING

The first medical center of PLA general hospital, Beijing

200032

RECRUITING

Fudan University Shanghai Cancer Center, Shanghai

250117

RECRUITING

Cancer Hospital of Shandong First Medical University, Jinan

272000

RECRUITING

Affiliated Hospital of Jining Medical University, Jining

430100

RECRUITING

HunanCancer Hospital, Changsha

510060

RECRUITING

Sun Yat-sen University Cancer Center, Guangzhou

07601

RECRUITING

Hackensack University Medical Center, Hackensack

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Shanghai Xianxiang Medical Technology Co., Ltd.

INDUSTRY

lead

NextCure, Inc.

INDUSTRY

NCT06792552 - A Phase I Study of SIM0505 in Participants With Advanced Solid Tumors | Biotech Hunter | Biotech Hunter