Actively Recruiting
First in Human Study of SIM0610 in Solid Tumors
Led by Jiangsu Simcere Pharmaceutical Co., Ltd. · Updated on 2026-01-23
260
Participants Needed
7
Research Sites
179 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 a multicenter, open-label, first-in-human (FIH) study to evaluate the safety, tolerability, pharmacokinetic/pharmacodynamic profile, and preliminary antitumor activity of SIM0610 in subjects with locally advanced/metastatic solid tumors. Accelerated titration (ATD) and Bayesian optimal interval design (BOIN) will be used to guide dose escalation in part1, the preliminary anti-tumor effect of SIM0610 will to be further evaluated in part 2.
CONDITIONS
Official Title
First in Human Study of SIM0610 in Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily participate and sign the informed consent form
- Be at least 18 years old, male or female
- Have locally advanced or metastatic solid tumors confirmed by histology or cytology
- In Part 1, have at least one tumor lesion evaluable by RECIST v1.1 criteria
- In Part 2, have at least one measurable tumor lesion by RECIST v1.1 that has not been treated or has clearly progressed
- Have disease progression after at least one prior standard systemic anti-tumor treatment and be unsuitable for standard treatment
- Have an ECOG performance status of 0 or 1
- Have an expected survival period of at least 12 weeks
- Have adequate organ and bone marrow function
- Provide archived tumor tissue or fresh biopsy within 5 years before first treatment
You will not qualify if you...
- History of active second primary malignancy within past 2 years except low-risk localized tumors considered cured
- Symptomatic central nervous system metastases within 2 weeks before first dose or requiring local therapy or corticosteroids
- History or current non-infectious interstitial lung disease or pulmonary inflammation requiring corticosteroids or suspected but not ruled out by imaging
- Uncontrolled pleural, pericardial effusion, or ascites requiring drainage or intervention within 4 weeks before first dose
- Failure to recover to Grade 1 or baseline from adverse events caused by prior anti-tumor therapy
- Current or recent (within 4 weeks) participation in other investigational drug or device studies
- Recent cytotoxic therapy within 3 weeks or targeted small-molecule drugs within 2 weeks before first dose
- Recent immune checkpoint inhibitors, ADCs, or other biologics within 5 half-lives or 4 weeks before first dose
- Use of traditional Chinese medicines with anti-tumor effects within 2 weeks before first dose
- Radiotherapy within 4 weeks before first dose
- Previous treatment with ADCs containing topoisomerase I inhibitors or targeting EGFR/cMET
- Receipt of live vaccines within 4 weeks before first dose
- Use of strong or moderate CYP3A4 modulators, drugs at risk for torsade de pointes, or drugs prolonging QTcF interval within 14 days before first dose
- Known HIV infection or AIDS
- Significant cardiovascular diseases within 6 months before first dose including myocardial infarction, unstable angina, cardiomyopathy, stroke, or heart failure above NYHA Class II
- History of allogeneic organ transplantation or graft-versus-host disease
- Known allergy to SIM0610 or similar drugs
- Pregnant or lactating women; women of childbearing potential must have negative pregnancy test and use effective contraception until 180 days after last dose
- Male participants must use effective contraception if their partners are of childbearing potential until 180 days after last dose
- Any other condition increasing risks or interfering with study results as judged by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 7 locations
1
Chongqing Cancer Hospital
Chongqing, Chongqing Municipality, China, 400000
Not Yet Recruiting
2
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China, 150000
Not Yet Recruiting
3
the First Hospital of China Medical University
Shenyang, Liaoning, China, 110000
Not Yet Recruiting
4
The Affiliated Cancer Hospital of Shandong First Medical University& Shan Dong Cancer Hospital
Jinan, Shandong, China, 250117
Actively Recruiting
5
Shanghai East Hospital
Shanghai, Shanghai Municipality, China, 200000
Not Yet Recruiting
6
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, China, 200000
Not Yet Recruiting
7
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, China, 200000
Not Yet Recruiting
Research Team
J
Jiawei Yao
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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