Actively Recruiting
A Phase I Study to Investigate the Safety, Pharmacokinetics, and Preliminary Antitumor Activity of SIM0609 in Adults With Locally Advanced or Metastatic Solid Tumors
Led by Jiangsu Simcere Pharmaceutical Co., Ltd. · Updated on 2025-12-05
232
Participants Needed
6
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 the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of SIM0609 in adults with locally advanced or metastatic solid tumors. This phase I, open-label, multicenter trial aims to explore how SIM0609 behaves in the body and its potential effects on different types of advanced solid cancers. The study is sponsored by Jiangsu Simcere Pharmaceutical Co., Ltd. and focuses on adults who have failed standard treatments for their cancer. The study involves multiple dose levels of SIM0609 to identify the maximum tolerated dose through a dose escalation phase. Following this, dose expansion phases will test 1 to 3 dose levels to assess preliminary antitumor activity in specific tumor types including colorectal carcinoma, gastric/gastroesophageal junction adenocarcinoma, pancreatic ductal adenocarcinoma, and other solid tumors. Participants receive SIM0609 injections with dosing cycles lasting 21 or 28 days. Participants will be closely monitored for dose-limiting toxicities by the end of the first treatment cycle, along with safety and response outcomes over a two-year period. Researchers will evaluate tumor response rates and collect data on tolerability and pharmacokinetics. Assessments include tumor measurements and safety evaluations. The total duration of follow-up for participants can extend up to two years to gather comprehensive information on treatment effects and side effects.
CONDITIONS
Brief 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 and signed informed consent
- Adults aged 18 years or older
- Histologically or cytologically confirmed locally advanced or metastatic solid tumors
- At least one measurable or evaluable tumor lesion
- Failed standard therapy for locally advanced or metastatic cancer
- ECOG performance status of 0 or 1
- Expected survival of at least 12 weeks
- Adequate organ and bone marrow function
- Availability of tumor tissue sample within 28 days before first study drug administration
You will not qualify if you...
- Active second primary cancers within past 2 years except for cured localized cancers
- Symptomatic central nervous system metastases or requiring recent CNS therapy
- History or current interstitial lung disease or pneumonitis requiring steroids
- Serious or unstable systemic disorders incompatible with study
- Active infections needing systemic therapy within 2 weeks prior to study
- Uncontrolled pleural, pericardial effusion, or ascites requiring intervention
- Not recovered from adverse effects of prior anticancer therapy
- Participation in another investigational study within 4 weeks prior to study
- Recent anticancer therapies within specified timeframes prior to study start
- Prior exposure to specific antibody drug conjugate therapies
- Use of live vaccines within 4 weeks prior to first dose
- Use of certain medications affecting drug metabolism within 14 days prior
- Major surgery within 2 weeks before first dose
- Known HIV infection or AIDS
- Active or chronic hepatitis B or C infection
- Significant cardiovascular diseases
- History of organ transplantation or graft-versus-host disease
- Hypersensitivity to SIM0609 or related drugs
- Pregnant or nursing women
- Male participants with female partners of reproductive potential not using effective contraception
- Any other condition increasing risk or interfering with study participation per investigator's judgment
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 - Each cycle lasts 21 to 28 days; dosing continues through multiple cycles during the study period.
Participants receive multiple dose levels of SIM0609 to evaluate safety, pharmacokinetics, and preliminary antitumor activity.
Visits occur during each treatment cycle as per protocol
Duration - Up to 2 years
Participants are monitored for safety, tolerability, and tumor response after treatment completion.
Regular follow-up visits for up to 2 years after treatment
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
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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