Clinical Trial

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

Recruiting Phase 1
View on ClinicalTrials.gov →
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
Protocol Amendment History 2 changes
critical Primary endpoint(s) modified 2026-07-29
notable Enrollment increased: 414 -> 738 participants 2026-07-29
Trial Details
NCT Number NCT06792552
Lead Sponsor NextCure, Inc.
Collaborators: Shanghai Simcere Zaiming Biotechnology Co., Ltd.
Conditions Advanced Solid Tumors, Platinum Resistant Ovarian Cancer, Fallopian Tube Cancer, Renal Cell Carcinoma (RCC), Papillary Renal Cell Carcinoma (Prcc), Uterine Serous Carcinoma (USC), NSCLC (Non-small Cell Lung Cancer), Primary Peritoneal Cancer
Enrollment 738 participants
Start Date 2025-02-26
Primary Completion 2028-02 (estimated)
Study Completion 2028-08 (estimated)
Updated on ClinicalTrials.gov 2026-07-28