A Phase I Study of SIM0505 in Participants With Advanced Solid Tumors
← catalyst calendarNCT06792552 · readout ≤ 559 d
Sponsored by NextCure, Inc. (industry) · NXTC — their whole pipeline →. With Shanghai Simcere Zaiming Biotechnology Co., Ltd..
Phase
Phase 1
Status
Recruiting
Study type
Interventional
Design
Randomized · None · Treatment
Enrollment
738estimated
Sites
17
Countries
China, United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2025-02-26 | actual | When the study began enrolling |
| Primary completion | Feb 2028 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Aug 2028 | estimated | The whole study's end, after follow-up |
| First posted | 2025-01-24 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-08-17 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
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
Interventions
- Drug: SIM0505 for injection
- Drug: SIM0505 for injection
Primary outcomes
what the primary-completion date above is the date OFdose escalation: Dose-limiting toxicity (DLT)
measured At the end of Cycle 1 (each cycle is 21 days)
dose escalation & optimization: Adverse events (AEs)
measured the whole dose escalation phase，an average of 2 year
dose optimization：Objective response rate (ORR)
measured the whole dose optimization phase，an average of 1.5 year
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