Advanced Solid TumoursPhase 1SIM0610-101NCT07348211
First in Human Study of SIM0610 in Solid Tumors
A Phase 1 study testing SIM0610 for Injection in people with Advanced Solid Tumours and Non-Small Cell Lung Cancer, run by Jiangsu Simcere Pharmaceutical Co., Ltd. at 7 sites in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumours, Non-Small Cell Lung Cancer, Colorectal Cancer
- What is being tested?
- SIM0610 for Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 260 participants
- Where
- 7 sitesChina
- Study dates
- 19 Jan 2026to Jul 2029
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntarily participate and sign the informed consent form
- At least 18 years old, male or female
- Subjects with locally advanced/metastatic solid tumors confirmed by histology and/or cytology;
- Subjects in Part 1 should have at least one tumor lesion evaluable by RECIST v1.1 criteria, and subjects in Part 2 should have at least one measurable tumor lesion by RECIST v1.1 (lesions that have received radiotherapy or other local treatments cannot be used as target lesions unless there is clear progression of the lesion)
- Subjects with locally advanced/metastatic solid tumors who have failed standard treatment: Part 1: Subjects with solid tumors who have experienced disease progression during/after at least one previous standard systemic anti-tumor regimen and are not suitable for standard treatment. Part 2: Non-small cell lung cancer, liver cancer, head and neck squamous cell carcinoma, colorectal cancer that have experienced disease progression during/after at least one previous standard systemic anti-tumor regimen and are not suitable for standard treatment
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
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- Expected survival period ≥ 12 weeks
- Adequate organ and bone marrow function
- Archived formalin-fixed, paraffin-embedded (FFPE) tumor tissue or fresh biopsy tissue within 5 years must be provided before the first administration
Who cannot join
- A history of active second primary malignancy within the past 2 years, except for localized tumors that are considered cured and have a low risk of recurrence as assessed by the investigator.
- Symptomatic central nervous system (CNS) metastases occurring within 2 weeks prior to the first dose of study treatment; or requirement for local therapy (e.g., radiotherapy or surgery) for CNS metastases; or requirement for corticosteroid therapy for CNS metastases.
- A history of non-infectious interstitial lung disease (ILD)/pulmonary inflammation requiring corticosteroid treatment; current ILD/pulmonary inflammation; or suspected ILD/pulmonary inflammation that cannot be ruled out by screening imaging.
- Uncontrolled pleural effusion, pericardial effusion, or ascites, or occurrence of such effusions requiring drainage or medical intervention within 4 weeks prior to the first dose of study treatment.
- Failure to recover from adverse events (AEs) induced by prior anti-tumor therapy (i.e., recovery to Grade 1 or baseline level).
- Current participation in a study involving investigational drugs or medical devices, or participation in such a study within 4 weeks prior to the first dose of study treatment.
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- Receipt of the following therapies prior to the first dose of study treatment:
- Cytotoxic therapy within 3 weeks; or anti-tumor targeted small-molecule drugs (e.g., tyrosine kinase inhibitors) within 2 weeks.
- Anti-tumor antibody-based immune checkpoint inhibitors, antibody-drug conjugates (ADCs), or other anti-tumor biologics within the shorter of 5 half-lives or 4 weeks.
- Traditional Chinese medicines (TCMs)/herbal preparations with anti-tumor indications within 2 weeks.
- Radiotherapy within 4 weeks.
- Received antibody-drug conjugate (ADC) with topoisomerase I inhibitor (TOP1i) or other ADC targeting EGFR/cMET.
- Received any live vaccine within 4 weeks prior to the first dose of study treatment.
- Received the following medications ≤ 14 days prior to the first dose of study treatment:
- Strong or moderate CYP3A4 induction/inhibitor;
- Drugs known to be at risk for torsade de pointes (TdP);
- Drugs associated with QTcF interval prolongation (TdP risk equivocal).
- Known human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS).
- A history of clinically significant cardiovascular diseases within 6 months prior to the first dose of study treatment, including but not limited to myocardial infarction, severe/unstable angina pectoris, primary cardiomyopathy, cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction) or congestive heart failure (New York Heart Association [NYHA] Functional Classification > Class II); symptomatic coronary artery disease requiring pharmacotherapy.
- A history of allogeneic organ transplantation or graft-versus-host disease (GVHD).
- A history of hypersensitivity to the active ingredients, inactive excipients of SIM0610, or drugs with similar chemical structures or classifications to SIM0610.
- Pregnant or lactating women. For women of childbearing potential (WOCBP), they are also excluded unless:
- The result of serum pregnancy test within 72 hours prior to the first dose of study treatment is negative;
- They use highly effective contraceptive methods from the time of signing the informed consent form (ICF) until 180 days after the last dose of study treatment.
- Male subjects with female partners of childbearing potential are excluded unless they use highly effective contraceptive methods from the time of signing the ICF until 180 days after the last dose of study treatment.
- Any other conditions that may increase subject-related risks or interfere with the interpretation of study results, and that, in the investigator's judgment, render the subject unsuitable for study enrollment.
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
China7 sites, 7 recruiting
- Not yet recruiting
Chongqing Cancer Hospital
Chongqing, Chongqing Municipality, 400000
Yongsheng Li
- Not yet recruiting
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, 150000
Tongsen Zheng
- Recruiting
The Affiliated Cancer Hospital of Shandong First Medical University& Shan Dong Cancer Hospital
Jinan, Shandong, 250117
Jinming Yu
- Not yet recruiting
Shanghai East Hospital
Shanghai, Shanghai Municipality, 200000
Ye Guo
- Not yet recruiting
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, 200000
Shengxiang Ren
- Not yet recruiting
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200000
Tianshu Liu
- Not yet recruiting
the First Hospital of China Medical University
Shenyang, Liaoning, 110000
Xiujuan Qu
About this study
Official title: An Open-Label, Multicenter, First-in-Human Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of SIM0610 in Adult Subjects With Locally Advanced/Metastatic Solid Tumors
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
- Advanced Solid Tumours, Non-Small Cell Lung Cancer, Colorectal Cancer, Head and Neck Squamous Cell Carcinoma, Hepatocellular Carcinoma
- Being tested
- SIM0610 for Injection
- Keywords
- Locally Advanced/Metastatic Solid Tumors
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Colorectal Neoplasms, Squamous Cell Carcinoma of Head and Neck, Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SIM0610 for InjectionDrug
intravenous infusion
SIM0610 for InjectionDrug
intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| Dose escalation | Experimental | SIM0610 administered intravenously at selected dose levels according to protocol Receives: Drug: SIM0610 for Injection |
| Cohort expansion | Experimental | SIM0610 administered intravenously at Recommended dosage(RDs) according to protocol Receives: Drug: SIM0610 for Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose Limiting Toxicity (DLT)
Measured: From time of first dose of SIM0610 to end of DLT period (approximately 21 days)
Safety and Tolerability
Measured: From time of Informed Consent to 28 days post last dose of SIM0610
Objective response rate (ORR)
Objective response rate (ORR) assessed by the investigator per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
Measured: From date of first dose of SIM0610 up until progression, or the last evaluable assessment in the absence of progression (approximately 2 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2026
- Study start19 Jan 2026
- Primary completionDec 2027 (estimated)
- Study completionJul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumoursStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 260 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu Simcere Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Shanghai Xianwei Medical Technology Co., Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07348211
- Sponsor's protocol ID
- SIM0610-101
- Acronym
- SIM0610-101
- Status last verified
- Jan 2026
- First submitted
- 24 Dec 2025
- Last updated
- 23 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Multicenter, First-in-Human Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of SIM0610 in Adult Subjects With Locally Advanced/Metastatic Solid Tumors
- ClinicalTrials.gov ID
- NCT07348211
- Acronym / sponsor ID
- SIM0610-101 / SIM0610-101
- Conditions
- Advanced Solid Tumours, Non-Small Cell Lung Cancer, Colorectal Cancer, Head and Neck Squamous Cell Carcinoma, Hepatocellular Carcinoma
- Keywords
- Locally Advanced/Metastatic Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 260 participants (estimated)
- Lead sponsor
- Jiangsu Simcere Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Shanghai Xianwei Medical Technology Co., Ltd.
- Study start
- 19 Jan 2026 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Jul 2029 (estimated)
- First posted
- 16 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dose escalation | Experimental | Drug: SIM0610 for InjectionSIM0610 administered intravenously at selected dose levels according to protocol |
| Cohort expansion | Experimental | Drug: SIM0610 for InjectionSIM0610 administered intravenously at Recommended dosage(RDs) according to protocol |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Voluntarily participate and sign the informed consent form
- At least 18 years old, male or female
- Subjects with locally advanced/metastatic solid tumors confirmed by histology and/or cytology;
- Subjects in Part 1 should have at least one tumor lesion evaluable by RECIST v1.1 criteria, and subjects in Part 2 should have at least one measurable tumor lesion by RECIST v1.1 (lesions that have received radiotherapy or other local treatments cannot be used as target lesions unless there is clear progression of the lesion)
- Subjects with locally advanced/metastatic solid tumors who have failed standard treatment: Part 1: Subjects with solid tumors who have experienced disease progression during/after at least one previous standard systemic anti-tumor regimen and are not suitable for standard treatment. Part 2: Non-small cell lung cancer, liver cancer, head and neck squamous cell carcinoma, colorectal cancer that have experienced disease progression during/after at least one previous standard systemic anti-tumor regimen and are not suitable for standard treatment
Key exclusion criteria (26 listed)
- A history of active second primary malignancy within the past 2 years, except for localized tumors that are considered cured and have a low risk of recurrence as assessed by the investigator.
- Symptomatic central nervous system (CNS) metastases occurring within 2 weeks prior to the first dose of study treatment; or requirement for local therapy (e.g., radiotherapy or surgery) for CNS metastases; or requirement for corticosteroid therapy for CNS metastases.
- A history of non-infectious interstitial lung disease (ILD)/pulmonary inflammation requiring corticosteroid treatment; current ILD/pulmonary inflammation; or suspected ILD/pulmonary inflammation that cannot be ruled out by screening imaging.
- Uncontrolled pleural effusion, pericardial effusion, or ascites, or occurrence of such effusions requiring drainage or medical intervention within 4 weeks prior to the first dose of study treatment.
- Failure to recover from adverse events (AEs) induced by prior anti-tumor therapy (i.e., recovery to Grade 1 or baseline level).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SIM0610 for Injectionintravenous infusion | Drug | Cohort expansion |
| SIM0610 for Injectionintravenous infusion | Drug | Dose escalation |
Primary outcome
Dose Limiting Toxicity (DLT)
Time frame: From time of first dose of SIM0610 to end of DLT period (approximately 21 days)
Safety and Tolerability
Time frame: From time of Informed Consent to 28 days post last dose of SIM0610
Objective response rate (ORR)
Time frame: From date of first dose of SIM0610 up until progression, or the last evaluable assessment in the absence of progression (approximately 2 years)
Objective response rate (ORR) assessed by the investigator per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SIM0610 for Injection in people with Advanced Solid Tumours and Non-Small Cell Lung Cancer, run by Jiangsu Simcere Pharmaceutical Co., Ltd. at 7 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jiawei Yao (+8618868816194, yaojiawei@zaiming.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose Limiting Toxicity (DLT) (time frame: From time of first dose of SIM0610 to end of DLT period (approximately 21 days)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2026.