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

ClinicalTrials.gov ID: NCT06792552

Public ClinicalTrials.gov record NCT06792552. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced Sep 1, 2026, 5:36 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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

Study identification

NCT ID: NCT06792552
Recruitment status: Recruiting
Study type: Interventional
Phase: Phase 1
Lead sponsor: NextCure, Inc.; Industry
Enrollment: 738 participants

Conditions and interventions

Conditions

Interventions

SIM0505 for injection Drug

Drug

Eligibility (public fields only)

Age range: 18 Years and older
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Feb 25, 2025
Primary completion: Jan 31, 2028
Completion: Jul 31, 2028
Last update posted: Aug 16, 2026

2025 – 2028

United States locations

U.S. sites: 9
U.S. states: 8
U.S. cities: 9

Facility	City	State	ZIP	Site status
Sarah Cannon Research Institute (SCRI) - Lake Nona	Orlando	Florida	32827	Active, not recruiting
Emory Winship Cancer Institute	Atlanta	Georgia	30322	Active, not recruiting
University Medical Center of New Orleans LSU-LCMC Health Cancer Center	New Orleans	Louisiana	70112	Active, not recruiting
Dana-Farber Cancer Institute	Boston	Massachusetts	02215	Active, not recruiting
Hackensack University Medical Center	Hackensack	New Jersey	07601	Active, not recruiting
Roswell Park Cancer Institute	Buffalo	New York	14263	Active, not recruiting
Icahn School of Medicine at Mount Sinai	New York	New York	10128	Active, not recruiting
Sarah Cannon Research Institute (SCRI) - Nashville	Nashville	Tennessee	37203	Active, not recruiting
UT Health San Antonio - Mays Cancer Center	San Antonio	Texas	78229	Active, not recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 8 non-U.S. sites.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT06792552, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Aug 16, 2026 · Synced Sep 1, 2026

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The complete protocol, eligibility criteria, and contact information for NCT06792552 live on ClinicalTrials.gov.

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