A Phase I First-in-human, Open-label, Multicenter Study to Investigate the Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of SIM0505 in Adult Participants With Advanced Solid Tumors
NextCure, Inc.
Summary
This is an open-label, multicenter phase 1 study to evaluate the safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of SIM0505 in Adult Participants with Advanced Solid Tumors
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Written informed consent is obtained prior to any procedures that are not considered standard of care 2. ≥18 years of age. 3. In Part 1: 1. Participants with histologically or cytologically confirmed advanced solid tumors, who have failed or are ineligible for standard of care therapies. 2. Have progressed on at least one prior systematic anti-tumor regimen, and presence of at least one evaluable lesion according to RECIST Version 1.1. Measurable lesions are required in the backfill period. 3. In the backfill period, eligible tumor types are limited to high-gr…
Interventions
- DrugSIM0505 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.
- DrugSIM0505 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
Locations (17)
- Sarah Cannon Research Institute (SCRI) - Lake NonaOrlando, Florida
- Emory Winship Cancer InstituteAtlanta, Georgia
- University Medical Center of New Orleans LSU-LCMC Health Cancer CenterNew Orleans, Louisiana
- Dana-Farber Cancer InstituteBoston, Massachusetts
- Hackensack University Medical CenterHackensack, New Jersey
- Roswell Park Cancer InstituteBuffalo, New York