Actively Recruiting
A Phase I First-in-Human, Open-label, Multicenter Study to Investigate the Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of SIM0686 in Adult Participants With Locally Advanced/Metastatic Solid Tumors
Led by Jiangsu Simcere Pharmaceutical Co., Ltd. · Updated on 2025-07-03
220
Participants Needed
10
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating SIM0686, a drug being studied for safety, tolerability, how it moves through the body, and its early effects against locally advanced or metastatic solid tumors in adults. This open-label, phase 1 study involves multiple centers and aims to better understand the drug's impact in patients whose cancers have progressed despite standard treatments. Participants will receive SIM0686 intravenously in increasing doses to assess safety and find the recommended dose. After this dose escalation phase, the determined dose will be further evaluated in select patient groups with specific tumor types. Each treatment cycle lasts 21 days, and the study includes both dose escalation and cohort expansion phases. During the study, researchers will monitor dose-limiting toxicities, adverse events, and overall response rates to the drug. Participants will undergo evaluations including tumor lesion measurements, tissue biopsies, and organ function assessments. The trial may last up to about two years during the main phases, with ongoing safety monitoring throughout treatment.
CONDITIONS
Brief Title
A Phase I Study of SIM0686 in Participants With Locally Advanced/Metastatic Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntary participation and signature of informed consent form
- At least 18 years old, male or female
- Histologically and/or cytologically confirmed locally advanced/metastatic solid tumors
- At least one evaluable or measurable tumor lesion (RECIST v1.1)
- Failed the standard of therapy in the locally advanced/metastatic setting
- Eastern Cooperative Oncology Group (ECOG) performance score of 0 or 1
- Expected survival of at least 12 weeks
- Adequate organ and bone marrow function
- Availability of archival formalin-fixed, paraffin-embedded (FFPE) tumor tissue, or fresh biopsies within 6 months before first administration for evaluation of FGFR2b expression levels
You will not qualify if you...
- Active second primary malignancies within the previous 2 years except for localized cancers considered cured and low risk
- Symptomatic central nervous system (CNS) metastases or CNS metastases requiring therapy within 2 weeks of first dose
- Active or significant corneal disorders or clinically significant corneal disease preventing monitoring
- History of (non-infectious) interstitial lung disease (ILD)/pneumonitis requiring steroids, current ILD/pneumonitis, or suspected ILD/pneumonitis
- Not recovered to Grade 1 or baseline from previous anticancer therapy-induced adverse events
- Received prior cytotoxic therapy or targeted small molecules within 2 weeks
- Received anti-cancer antibody, immune checkpoint inhibitor, or ADC within 5 half-lives or 4 weeks
- Taken Chinese medicines/herbal preparations with anticancer indication within 2 weeks
- Received radiation therapy within 4 weeks
- Prior exposure to topoisomerase I inhibitor-based ADC therapies or FGFR2b-targeted ADC therapies
- Known HIV infection or AIDS
- Active or chronic hepatitis B or hepatitis C infection
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 increasing dose levels of SIM0686 administered intravenously as monotherapy or at recommended doses in select indications.
Visits every 21 days for treatment administration and monitoring
Trial Site Locations
Total: 10 locations
1
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China, 100021
Not Yet Recruiting
2
Harbin Medical University Cancer Hospital
Haerbin, Heilongjiang, China, 150081
Not Yet Recruiting
3
The Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital
Zhengzhou, Henan, China, 450003
Not Yet Recruiting
4
Hunan Cancer Hospital
Changsha, Hunan, China, 410017
Not Yet Recruiting
5
Nanjing Tianyinshan Hospital
Nanjing, Jiangsu, China, 210008
Actively Recruiting
6
Cancer Hospital of Shandong First Medical University（Shandong Cancer Hospital&Institute）
Jinan, Shandong, China, 250117
Not Yet Recruiting
7
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China, 200032
Not Yet Recruiting
8
Shanghai Gobroad Cancer Hospital
Shanghai, Shanghai Municipality, China, 200131
Actively Recruiting
9
Sichuan Cancer Hospital
Chengdu, Sichuan, China, 610040
Actively Recruiting
10
Tianjin Cancer Hospital
Tianjin, Tianjin Municipality, China, 300060
Not Yet Recruiting
Research Team
Z
Zhi Zhang
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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