Actively Recruiting
A Phase I Study of SIM0609 in Adult Participants With Locally Advanced/Metastatic Solid Tumors
Led by Jiangsu Simcere Pharmaceutical Co., Ltd. · Updated on 2025-12-05
232
Participants Needed
6
Research Sites
186 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
This is an open-label,multicenter phase I study to evaluate the safety,Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of SIM0609 in Adult Participants with Locally Advanced/Metastatic Solid Tumors
CONDITIONS
Official Title
A Phase I Study of SIM0609 in Adult Participants With Locally Advanced/Metastatic Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntary participation with signed informed consent
- Age 18 years or older, any gender
- Histologically or cytologically confirmed locally advanced or metastatic solid tumors
- At least one evaluable or measurable tumor lesion
- Failure of standard therapy for locally advanced or metastatic disease
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Expected survival of at least 12 weeks
- Adequate organ and bone marrow function
- Availability of archival tumor tissue or fresh biopsy within 28 days before first treatment
You will not qualify if you...
- Active second primary cancers within 2 years except cured localized cancers with low recurrence risk
- Symptomatic central nervous system metastases or those needing recent local therapy or steroids
- History or current interstitial lung disease or pneumonitis requiring steroids or suspected cases not ruled out by imaging
- Serious or unstable systemic disorders incompatible with the study
- Active infections requiring systemic therapy within 2 weeks before study treatment
- Uncontrollable pleural, pericardial effusion or ascites needing drainage within 4 weeks before treatment
- Unresolved adverse events from previous anticancer treatment
- Participation in another investigational study or device use within 4 weeks before treatment
- Recent prior therapies: cytotoxic or small molecules within 2 weeks; antibodies, checkpoint inhibitors, or ADCs within 4 weeks or 5 half-lives; herbal anticancer medicines within 2 weeks; radiation within 4 weeks
- Prior exposure to topoisomerase I inhibitor-based ADCs or CDH17-targeted ADCs
- Use of live vaccines within 4 weeks before treatment
- Use of strong/moderate CYP3A4 inducers/inhibitors, drugs with TdP risk, or QT prolonging drugs within 14 days before treatment
- Major surgery within 2 weeks before treatment
- Known HIV infection or AIDS
- Active or chronic hepatitis B or C infection
- Clinically significant cardiovascular diseases
- History of allogeneic organ transplant or graft-versus-host disease
- Hypersensitivity to SIM0609 or similar drugs
- Pregnant or nursing women
- Male participants with female partners of reproductive potential not using effective contraception from consent to 180 days after last dose
- Any other condition judged by the investigator to increase risk or interfere with study results
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 6 locations
1
Beijing Cancer Hospital
Beijing, China
Actively Recruiting
2
Jiangsu Province Hospital
Nanjing, China
Not Yet Recruiting
3
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, China
Not Yet Recruiting
4
Zhongshan Hospital，Fudan University
Shanghai, China
Not Yet Recruiting
5
Tianjin Cancer Hospital
Tianjin, China
Not Yet Recruiting
6
Hubei Cancer Hospital
Wuhan, China
Not Yet Recruiting
Research Team
J
Jinxiu Zhang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
5
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