Actively Recruiting
An Open-Label, Multicenter First-in-Human Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of SIM0610 in Adults With Locally Advanced/Metastatic Solid Tumors
Led by Jiangsu Simcere Pharmaceutical Co., Ltd. · Updated on 2026-01-23
260
Participants Needed
7
Research Sites
82 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 SIM0610 in a first-in-human, open-label, multicenter study to assess its safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity in adults with locally advanced or metastatic solid tumors. The study uses accelerated titration and Bayesian optimal interval design methods to guide dose escalation, aiming to understand how SIM0610 behaves in the body and its potential effect on various advanced solid cancers. Participants will receive SIM0610 through intravenous infusion in two parts of the study: part 1 focuses on dose escalation to find appropriate dose levels, and part 2 expands the cohort to further assess anti-tumor effects at the recommended dose. Treatment is given according to the study protocol, with doses and schedules carefully monitored throughout. During the study, participants will be closely monitored for dose-limiting toxicities within about 21 days after the first dose and safety up to 28 days following the last dose. Tumor response will be evaluated for up to approximately two years to assess the objective response rate. Participants will undergo assessments including tumor lesion evaluations using RECIST criteria, organ function tests, and provide tumor tissue samples before treatment. The study aims to collect detailed data on safety and possible anti-tumor activity over the course of treatment and follow-up.
CONDITIONS
Brief Title
First in Human Study of SIM0610 in Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily agree to participate and sign informed consent
- At least 18 years old, male or female
- Diagnosed with locally advanced or metastatic solid tumors confirmed by histology or cytology
- Have at least one tumor lesion evaluable by RECIST v1.1 (Part 1) or measurable tumor lesion by RECIST v1.1 (Part 2)
- Have experienced disease progression during or after at least one prior standard systemic anti-tumor treatment and are not suitable for standard treatment
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Expected survival of 12 weeks or more
- Adequate organ and bone marrow function
- Provide archived or fresh tumor tissue sample within 5 years before treatment
You will not qualify if you...
- History of active second primary cancer within 2 years, except cured localized tumors with low recurrence risk
- Symptomatic central nervous system metastases within 2 weeks before treatment or requiring local therapy or corticosteroids
- History or current non-infectious interstitial lung disease or pulmonary inflammation requiring corticosteroids
- Uncontrolled pleural, pericardial effusion, or ascites needing drainage or intervention within 4 weeks before treatment
- Not recovered from adverse events related to prior anti-tumor therapy
- Participation in other investigational drug or device studies within 4 weeks before treatment
- Recent receipt of cytotoxic therapy, targeted therapies, immune checkpoint inhibitors, antibody-drug conjugates, traditional Chinese medicines, or radiotherapy within specified timeframes before treatment
- Previous treatment with ADCs targeting topoisomerase I inhibitor or EGFR/cMET
- Received live vaccines within 4 weeks prior to treatment
- Use of certain medications affecting metabolism or heart rhythm within 14 days before treatment
- Known HIV infection or AIDS
- Significant cardiovascular disease within 6 months before treatment
- History of organ transplantation or graft-versus-host disease
- Hypersensitivity to SIM0610 or similar drugs
- Pregnant or breastfeeding women; women of childbearing potential must have negative pregnancy test and use effective contraception
- Male participants with partners of childbearing potential must use effective contraception
- Any condition increasing risk or interfering with study results as judged by the investigator
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 - Approximately 21 days for dose limiting toxicity period, continuing up to disease progression or last evaluable assessment (approximately 2 years).
Participants receive intravenous infusions of SIM0610 at selected dose levels or recommended dosages according to the protocol.
Multiple visits for intravenous infusions and assessments during treatment period
Duration - 28 days post last dose
Participants are monitored for safety and tolerability up to 28 days after the last dose of SIM0610.
Visits for safety follow-up assessments
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
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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