Actively Recruiting
A Phase I First-in-human, Open-label, Multicenter Study to Investigate the Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of SIM0613 in Participants With Advanced Solid Tumors
Led by Jiangsu Simcere Pharmaceutical Co., Ltd. · Updated on 2026-06-01
294
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
Sponsors
J
Jiangsu Simcere Pharmaceutical Co., Ltd.
Lead Sponsor
S
Shanghai Xianwei Medical Technology Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating SIM0613, a new drug administered by intravenous infusion, in participants with locally advanced or metastatic solid tumors. This open-label, first-in-human Phase 1 study aims to assess the safety, tolerability, effectiveness, and how the drug moves and acts in the body. The trial includes people who have progressed on or cannot tolerate standard therapies or for whom the trial drug is considered standard treatment. The study is divided into two parts: Part 1 involves dose escalation to find the appropriate dosing, followed by Part 2 which expands dosing to different solid tumor types. Treatment consists of cycles of intravenous infusions of SIM0613. Tumor tissue samples are collected at screening or prior to consent for biomarker analysis, with specific requirements depending on the study part. Participants will undergo regular safety and response monitoring for up to two years, including assessments of dose-limiting toxicity within the first 21 days and objective tumor response rate over two years. Organ function tests, pregnancy testing for women of childbearing potential, and tumor measurements per RECIST criteria will be conducted. Safety follow-up and long-term observation are included to gather detailed information on the drug's effects and tolerability.
CONDITIONS
Brief Title
SIM0613 in Participants With Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Written informed consent is obtained before any study procedures
- Age 18 years or older
- Histologically or cytologically confirmed locally advanced or metastatic solid tumors
- At least one measurable tumor according to RECIST Version 1.1
- Disease progression after at least one standard therapy, or intolerance to or unsuitability for standard therapy, or investigational drug is standard treatment
- Life expectancy of 12 weeks or more
- Adequate organ function
- Women of childbearing potential must have a negative serum pregnancy test within 3 days before treatment starts
- For dose escalation (Part 1), archival or fresh tumor tissue sample should be collected if available
- For dose expansion (Part 2), archival tumor tissue sample within 6 months prior to consent or fresh tumor tissue at screening is mandatory
You will not qualify if you...
- Any other malignancy within 2 years before treatment except certain localized cancers with low risk of recurrence
- Symptomatic central nervous system metastases or those requiring recent CNS-directed therapy or corticosteroids within 2 weeks before treatment
- History of bowel obstruction within 3 months before treatment
- Known psychiatric disorder or drug abuse interfering with study requirements
- Uncontrollable pleural, pericardial effusion, or ascites needing intervention within 4 weeks before treatment
- Active infection requiring intravenous systemic treatment within 2 weeks before treatment
- Not recovered from previous anticancer therapy side effects
- Participation in another investigational study or device use within 4 weeks before treatment
- Major surgery within 2 weeks before treatment (minor procedures excluded)
- Prior exposure to topoisomerase I inhibitor-based ADC therapies or LRRC15-targeted therapies
- Use of live vaccine within 4 weeks before treatment
- Known HIV infection or AIDS
- Active hepatitis B infection
- History of allogeneic organ transplantation or graft-versus-host disease
- Known allergy to study drug or its components
- Pregnancy or breastfeeding
- Other conditions deemed inappropriate by researchers
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated 21-day cycles until disease progression or discontinuation
Participants receive SIM0613 administered as an intravenous infusion in dosing cycles.
1 visit per dosing cycle (in-person)
Trial Site Locations
Total: 1 location
1
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, China, 300060
Actively Recruiting
Research Team
Q
Qiuping Huang, Master
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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