Actively Recruiting
A Phase I Study of SIM0686 in 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
184 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is an open-label, multicenter phase 1 study to evaluate the safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of SIM0686 in Adult Participants with Locally Advanced/Metastatic Solid Tumors
CONDITIONS
Official 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...
- Voluntarily agree to participate and sign informed consent
- Age 18 years or older, male or female
- Histologically or cytologically confirmed locally advanced or metastatic solid tumors
- At least one measurable or evaluable tumor lesion according to RECIST v1.1
- Disease progression after standard 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 or fresh tumor tissue within 6 months for FGFR2b expression evaluation
You will not qualify if you...
- Active second primary malignancies within the past 2 years except for localized cancers considered cured
- Symptomatic central nervous system (CNS) metastases or CNS metastases requiring local therapy or corticosteroids within 2 weeks prior to treatment
- Active or chronic corneal disorders or significant ocular conditions preventing monitoring of drug-induced keratopathy
- History of or current interstitial lung disease (ILD)/pneumonitis requiring steroids or suspected ILD/pneumonitis not ruled out by imaging
- Unresolved adverse events from prior anticancer treatments (not recovered to Grade 1 or baseline)
- Recent therapies before study start: cytotoxic or targeted small molecules within 2 weeks; antibodies, immune checkpoint inhibitors or ADCs within 4 weeks or 5 half-lives; anticancer Chinese medicines within 2 weeks; radiation therapy within 4 weeks
- Prior exposure to topoisomerase I inhibitor-based ADCs or FGFR2b-targeted ADC therapies
- Known HIV infection or AIDS
- Active or chronic hepatitis B or C infection
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
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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