Advanced Solid CancerPhase 1Solid TumorsNCT07265921
A Phase I Study of SIM0609 in Adult Participants With Locally Advanced/Metastatic Solid Tumors
A Phase 1 study testing SIM0609 for injection, dose expansion of SIM0609 in CRC and dose expansion of SIM0609 in GC/GEJC cohort in people with Advanced Solid Cancer, run by Jiangsu Simcere Pharmaceutical Co., Ltd. at 6 sites in China.
Trial summary
This is an open-label,multicenter phase I study to evaluate the safety,Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of SIM0609 in Adult Participants 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 Cancer
- What is being tested?
- SIM0609 for injection, dose expansion of SIM0609 in CRC and dose expansion of SIM0609 in GC/GEJC cohort
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 232 participants
- Where
- 6 sitesChina
- Study dates
- 7 Nov 2025to Jun 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
- Voluntary participation and signature of informed consent form;
- At least 18 years old, male or female;
- Participants with histologically and/or cytologically confirmed locally advanced/metastatic solid tumors;
- Participants should have at least one evaluable or measurable tumor lesion;
- Participants have failed the standard of therapy in the locally advanced/metastatic setting;
- Eastern Cooperative Oncology Group (ECOG) performance score of 0 or 1;
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- Expected survival ≥12 weeks;
- Adequate organ and bone marrow function;
- Availability of archival formalin-fixed, paraffin-embedded (FFPE) tumor tissue, or fresh biopsies within 28 days before first administration, is mandatory
Who cannot join
- Active second primary malignancies within the previous 2 years except for localized cancers that are considered to have been cured and in the opinion of the Investigator present a low risk for recurrence;
- Symptomatic central nervous system (CNS) metastases or CNS metastases requiring CNS-directed local therapy or corticosteroid treatment that occurred within 2 weeks prior to the first administration of the investigational treatment;
- Has a history of (non-infectious) interstitial lung disease (ILD)/pneumonitis that required steroids, current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging screening;
- Presence of any serious or unstable concomitant systemic disorder incompatible with the clinical study ;
- Any active infections requiring systemic therapy within 2 weeks prior to the initiation of the study treatment;
- Uncontrollable pleural effusion, pericardial effusion, or ascites requiring drainage or medical intervention within 4 weeks before the first dose of study treatment;
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- Not recovered from previous anticancer therapy-induced AEs(Adverse Events);
- Currently participating or has participated in a study of an investigational agent or using an investigational device within 4 weeks of first dose of study treatment;
- Received prior therapies within the following time frames prior to the first dose of study treatment:
- Previous cytotoxic therapy, anticancer targeted small molecules within 2 weeks.
- Anti-cancer antibody, immune checkpoint inhibitor or ADC within 5 half-lives or 4 weeks (whichever is shorter).
- Chinese medicines/herbal preparations with anticancer indication taken within 2 weeks.
- Radiation therapy within 4 weeks.
- Prior exposure to topoisomerase I inhibitor (TOP1i)-based antibody drug conjugate (ADC) therapies or CDH17-targeted ADC therapies.
- Use of any live vaccine therapy within 4 weeks prior to the first dose of study treatment.
- Administration of below medications ≤14 days prior to the first dose of study treatment.
- Strong or moderate CYP3A4 inducers/inhibitors;
- Drugs with known risk of Torsades de Pointes(TdP);
- Drugs that may prolong the QT interval;
- Major surgery within 2 weeks of receiving the first dose of study treatment;
- Known human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome ;
- Active or chronic hepatitis B or hepatitis C infection;
- Participants with clinically significant cardiovascular diseases;
- History of allogeneic organ transplantation or graft-versus-host disease;
- History of hypersensitivity to active or inactive excipients of SIM0609 or drugs with a similar chemical structure or class to SIM0609;
- Pregnant or nursing (lactating) women;
- Male participants with female partners of reproductive potential, unless they are using highly effective contraceptive methods from signing of informed consent to 180 days after the last dose of study treatment;
- Presence of any other condition that may increase the risk associate with study participant or may interfere with the interpretation of study results, and, in the opinion of the Investigator, would make the participant inappropriate for entry into the study.
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
China6 sites, 6 recruiting
- Recruiting
Beijing Cancer Hospital
Beijing
Lin Shen, 86-010-88196561, doctorshenlin@sina.cn
Lin Shen
- Not yet recruiting
Jiangsu Province Hospital
Nanjing
Linjun Zhu, +86-13951807457, 13951807457@139.com
- Not yet recruiting
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai
Jun Zhang, 86-021-64741635, zj10977@rjh.com.cn
- Not yet recruiting
Zhongshan Hospital，Fudan University
Shanghai
Tianshu Liu, +86-13681973996, liu.tianshu@zs-hospital.sh.cn
- Not yet recruiting
Tianjin Cancer Hospital
Tianjin
Ting Deng, +86-15802243063, xymcdengting@126.com
- Not yet recruiting
Hubei Cancer Hospital
Wuhan
Xinjun Liang, 86-027-8767045, Doctorlxj@163.com
About this study
Official title: A Phase I First-in-Human, Multicenter Study to Investigate the Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of SIM0609 in Adult Participants With Locally Advanced/Metastatic Solid Tumors
This is an open-label,multicenter phase I study to evaluate the safety,Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of SIM0609 in Adult Participants with Locally Advanced/Metastatic Solid Tumors
- Conditions
- Advanced Solid Cancer
- Being tested
- SIM0609 for injection, dose expansion of SIM0609 in CRC, dose expansion of SIM0609 in GC/GEJC cohort, dose expansion of SIM0609 in PDAC cohort, dose expansion of SIM0609 in positive other solid tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SIM0609 for injectionDrug
Multiple dose levels of SIM0609 will be explored in dose escalation
dose expansion of SIM0609 in CRCDrug
1~3 dose levels of SIM0609 will be explored in dose expansion to evaluate the preliminary anti-tumor activity of SIM0609 in colorectal carcinoma (CRC)
dose expansion of SIM0609 in GC/GEJC cohortDrug
1~3 dose levels of SIM0609 will be explored in dose expansion in GC/GEJC cohort
dose expansion of SIM0609 in PDAC cohortDrug
1~3 dose levels of SIM0609 will be explored in dose expansion in PDAC cohort
dose expansion of SIM0609 in positive other solid tumorsDrug
1~3 dose levels of SIM0609 will be explored in positive other solid tumors cohort
| Study group | Role | What they receive |
|---|---|---|
| A dose escalation of SIM0609 | Experimental | Multiple dose levels of SIM0609 will be explored in dose escalation, and determine the maximum tolerated dose. Receives: Drug: SIM0609 for injection |
| A dose expansion of SIM0609 -CRC cohort | Experimental | 1~3 dose levels of SIM0609 will be explored in dose expansion to evaluate the preliminary anti-tumor activity of SIM0609 in colorectal carcinoma (CRC) Receives: Drug: dose expansion of SIM0609 in CRC |
| A dose expansion of SIM0609-GC/GEJC cohort | Experimental | 1~3 dose levels of SIM0609 will be explored in dose expansion to evaluate the preliminary anti-tumor activity of SIM0609 in gastric/gastroesophageal junction adenocarcinoma (GC/GEJC) Receives: Drug: dose expansion of SIM0609 in GC/GEJC cohort |
| A dose expansion of SIM0609-PDAC cohort | Experimental | 1~3 dose levels of SIM0609 will be explored in dose expansion to evaluate the preliminary anti-tumor activity of SIM0609 in pancreatic ductal adenocarcinoma (PDAC) Receives: Drug: dose expansion of SIM0609 in PDAC cohort |
| A dose expansion of SIM0609-positive other solid tumors cohort | Experimental | 1~3 dose levels of SIM0609 will be explored in dose expansion to evaluate the preliminary anti-tumor activity of SIM0609 in positive other solid tumors Receives: Drug: dose expansion of SIM0609 in positive other solid tumors |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose escalation:Dose -limiting toxicity (DLT)
Measured: At the end of Cycle 1 (each cycle is 21/28days)
Dose escalation:Safety and Tolerability
Safety and tolerability: Incidence and severity of AEs and serious adverse events (SAEs) assessed by CTCAE v5.0, changes in laboratory values, vital signs, and ECGs. AE related dose interruptions, dose reduction and treatment discontinuation, dose intensity
Measured: 2 years
Dose escalation: Objective response rate(ORR)
Proportion of subjects who have a complete or partial response assessed by investigator per RECIST 1.1
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2025
- Study start7 Nov 2025
- Primary completionDec 2028 (estimated)
- Study completionJun 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 CancerStudies of the same condition, open and under way.
- More trials run by Jiangsu Simcere Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Sequential
- Model description
- Sequential Assignment
- Masking
- None (open label)
- Enrolment
- 232 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
- NCT07265921
- Sponsor's protocol ID
- SIM0609-101
- Acronym
- Solid Tumors
- Status last verified
- Sep 2025
- First submitted
- 20 Nov 2025
- Last updated
- 5 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I First-in-Human, Multicenter Study to Investigate the Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of SIM0609 in Adult Participants With Locally Advanced/Metastatic Solid Tumors
- ClinicalTrials.gov ID
- NCT07265921
- Acronym / sponsor ID
- Solid Tumors / SIM0609-101
- Conditions
- Advanced Solid Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 232 participants (estimated)
- Lead sponsor
- Jiangsu Simcere Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Shanghai Xianwei Medical Technology Co., Ltd.
- Study start
- 7 Nov 2025 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Jun 2029 (estimated)
- First posted
- 5 Dec 2025 (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 an open-label,multicenter phase I study to evaluate the safety,Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of SIM0609 in Adult Participants with Locally Advanced/Metastatic Solid Tumors
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 5
- Model description
- Sequential Assignment
| Arm | Type | Receives |
|---|---|---|
| A dose escalation of SIM0609 | Experimental | Drug: SIM0609 for injectionMultiple dose levels of SIM0609 will be explored in dose escalation, and determine the maximum tolerated dose. |
| A dose expansion of SIM0609 -CRC cohort | Experimental | Drug: dose expansion of SIM0609 in CRC1~3 dose levels of SIM0609 will be explored in dose expansion to evaluate the preliminary anti-tumor activity of SIM0609 in colorectal carcinoma (CRC) |
| A dose expansion of SIM0609-GC/GEJC cohort | Experimental | Drug: dose expansion of SIM0609 in GC/GEJC cohort1~3 dose levels of SIM0609 will be explored in dose expansion to evaluate the preliminary anti-tumor activity of SIM0609 in gastric/gastroesophageal junction adenocarcinoma (GC/GEJC) |
| A dose expansion of SIM0609-PDAC cohort | Experimental | Drug: dose expansion of SIM0609 in PDAC cohort1~3 dose levels of SIM0609 will be explored in dose expansion to evaluate the preliminary anti-tumor activity of SIM0609 in pancreatic ductal adenocarcinoma (PDAC) |
| A dose expansion of SIM0609-positive other solid tumors cohort | Experimental | Drug: dose expansion of SIM0609 in positive other solid tumors1~3 dose levels of SIM0609 will be explored in dose expansion to evaluate the preliminary anti-tumor activity of SIM0609 in positive other solid tumors |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Voluntary participation and signature of informed consent form;
- At least 18 years old, male or female;
- Participants with histologically and/or cytologically confirmed locally advanced/metastatic solid tumors;
- Participants should have at least one evaluable or measurable tumor lesion;
- Participants have failed the standard of therapy in the locally advanced/metastatic setting;
Key exclusion criteria (28 listed)
- Active second primary malignancies within the previous 2 years except for localized cancers that are considered to have been cured and in the opinion of the Investigator present a low risk for recurrence;
- Symptomatic central nervous system (CNS) metastases or CNS metastases requiring CNS-directed local therapy or corticosteroid treatment that occurred within 2 weeks prior to the first administration of the investigational treatment;
- Has a history of (non-infectious) interstitial lung disease (ILD)/pneumonitis that required steroids, current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging screening;
- Presence of any serious or unstable concomitant systemic disorder incompatible with the clinical study ;
- Any active infections requiring systemic therapy within 2 weeks prior to the initiation of the study treatment;
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 |
|---|---|---|
| SIM0609 for injectionMultiple dose levels of SIM0609 will be explored in dose escalation | Drug | A dose escalation of SIM0609 |
| dose expansion of SIM0609 in CRC1~3 dose levels of SIM0609 will be explored in dose expansion to evaluate the preliminary anti-tumor activity of SIM0609 in colorectal carcinoma (CRC) | Drug | A dose expansion of SIM0609 -CRC cohort |
| dose expansion of SIM0609 in GC/GEJC cohort1~3 dose levels of SIM0609 will be explored in dose expansion in GC/GEJC cohort | Drug | A dose expansion of SIM0609-GC/GEJC cohort |
| dose expansion of SIM0609 in PDAC cohort1~3 dose levels of SIM0609 will be explored in dose expansion in PDAC cohort | Drug | A dose expansion of SIM0609-PDAC cohort |
| dose expansion of SIM0609 in positive other solid tumors1~3 dose levels of SIM0609 will be explored in positive other solid tumors cohort | Drug | A dose expansion of SIM0609-positive other solid tumors cohort |
Primary outcome
Dose escalation:Dose -limiting toxicity (DLT)
Time frame: At the end of Cycle 1 (each cycle is 21/28days)
Dose escalation:Safety and Tolerability
Time frame: 2 years
Safety and tolerability: Incidence and severity of AEs and serious adverse events (SAEs) assessed by CTCAE v5.0, changes in laboratory values, vital signs, and ECGs. AE related dose interruptions, dose reduction and treatment discontinuation, dose intensity
Dose escalation: Objective response rate(ORR)
Time frame: 2 years
Proportion of subjects who have a complete or partial response assessed by investigator per RECIST 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 5 Dec 2025.
- 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.
6 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 SIM0609 for injection, dose expansion of SIM0609 in CRC and dose expansion of SIM0609 in GC/GEJC cohort in people with Advanced Solid Cancer, run by Jiangsu Simcere Pharmaceutical Co., Ltd. at 6 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 28 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 5 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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 Jinxiu Zhang (86-010-65212241, zhangjinxiu@zaiming.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose escalation:Dose -limiting toxicity (DLT) (time frame: At the end of Cycle 1 (each cycle is 21/28days)). 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 5 Dec 2025.