RecruitingPhase 1NCT06792552

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

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

Sponsor

NextCure, Inc.

Enrollment

738 participants

Start Date

Feb 26, 2025

Study Type

INTERVENTIONAL

Conditions

Advanced Solid Tumors Primary Peritoneal Cancer Fallopian Tube Cancer NSCLC (Non-small Cell Lung Cancer)Renal Cell Carcinoma (RCC)Platinum Resistant Ovarian Cancer Uterine Serous Carcinoma (USC)Papillary Renal Cell Carcinoma (Prcc)

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called SIM0505 for injection and a drug called SIM0505 for injection for people with advanced solid tumors. The study is currently recruiting participants at 17 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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 Nona

Orlando, Florida, United States

Emory Winship Cancer Institute

Atlanta, Georgia, United States

University Medical Center of New Orleans LSU-LCMC Health Cancer Center

New Orleans, Louisiana, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Hackensack University Medical Center

Hackensack, New Jersey, United States

Roswell Park Cancer Institute

Buffalo, New York, United States

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Sarah Cannon Research Institute (SCRI) - Nashville

Nashville, Tennessee, United States

UT Health San Antonio - Mays Cancer Center

San Antonio, Texas, United States

The first medical center of PLA general hospital

Beijing, Beijing Municipality, China

Liaoning Cancer Hospital & Institute

Shenyang, China, China

The Fourth Hospital of Hebei Medical University (Heibei Tumor Hospital)

Shijiazhuang, China, China

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

HunanCancer Hospital

Changsha, Hunan, China

Cancer Hospital of Shandong First Medical University

Jinan, Shandong, China

Affiliated Hospital of Jining Medical University

Jining, Shandong, China

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

View Full Details on ClinicalTrials.gov

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NCT06792552

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