Advanced Solid CancerPhase 1SIM0613-101NCT07618260
SIM0613 in Participants With Advanced Solid Tumors
A Phase 1 study testing SIM0613 in people with Advanced Solid Cancer, run by Jiangsu Simcere Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
This is a multicenter, open-label, first-in-human (FIH) study to evaluate the safety, tolerability, efficacy and pharmacokinetic/pharmacodynamic characteristics of SIM0613 in 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?
- SIM0613
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 294 participants
- Where
- 1 siteChina
- Study dates
- 15 May 2026to Dec 2028
- 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
- Written informed consent (ICF) is obtained prior to any of the specified procedures required for the study
- ≥18 years of age
- Histologically or cytologically confirmed locally advanced/metastatic solid tumors
- Have at least one measurable disease per RECIST Version 1.1 criteria
- Have experienced disease progression on/after at least one accessible standard therapy, or are intolerant to standard therapy, or are not suitable for standard therapy, or for whom clinical trial of the investigational drug serves as standard treatment
- Life expectancy of ≥12 weeks
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- Have adequate organ function
- Women of childbearing potential (WOCBP) must have a negative serum pregnancy test within 3 days prior to the start of study treatment.
- For Part 1, archival or fresh tumor tissue sample (preferably 12 with a minimum number of 10 sections) should be collected if available at Biomarker-screening or screening visit. For Part 2, it is mandatory to collect archival tumor tissue sample (preferably 12 with a minimum number of 10 sections) performed within 6 months prior to consent or fresh tumor tissue sample at Biomarker-screening or screening visit
Who cannot join
- Any other malignancy within 2 years prior to the first dose of the study treatment except for localized cancers that are considered to have been cured and in the opinion of the Investigator present a low risk for recurrence (e.g., basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix or breast)
- Participants with symptomatic central nervous system (CNS) metastases, or CNS metastases requiring CNS-directed local therapy (such as radiotherapy or surgery), or CNS metastases requiring corticosteroids therapy within 2 weeks of first dose of study treatment.
- History of bowel obstruction within 3 months prior to the first dose of study treatment.
- Known psychiatric disorder or drug abuse that would interfere the study requirements
- Uncontrollable pleural effusion, pericardial effusion, or ascites requiring drainage or medical intervention within 4 weeks before the first dose of study treatment
- Any active infection requires systemic treatment via intravenous infusion within 2 weeks prior to the first dose of study treatment
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- Has not recovered (i.e., to Grade 1 or to baseline) from previous anticancer therapy-induced AEs.
- Participant is currently participating or has participated in a study of an investigational agent or using an investigational device within 4 weeks of first dose of SIM0613.
- Major surgery within 2 weeks of receiving the first dose of study treatment (minor procedures such as mediastinoscopy, insertion of a central venous access device, insertion of a feeding tube, needle biopsy and percutaneous nephrostomy are not considered major surgery)
- Prior exposure to topoisomerase I (TOP-I) inhibitor inhibitor-based antibody-drug conjugate (ADC) therapies or LRRC15-targeted therapies.
- Use of any live vaccine therapy within 4 weeks prior to the first dose of study treatment
- Known human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS)
- Active hepatitis B (HBsAg or HBcAb positive）
- History of allogeneic organ transplantation or graft-versus-host disease
- Known hypersensitivity to study drug or any of the excipients
- Participant is pregnant or breastfeeding
- Other conditions that researchers consider inappropriate for inclusion.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, 300060
Jihui Hao, PHD, +86 022-23340123-3070, haojihui@tjmuch.com
About this study
Official title: A Phase I First-in-human, Open-label, Multicenter Study to Investigate the Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of SIM0613 in Participants With Advanced Solid Tumors
This is a multicenter, open-label, first-in-human (FIH) study to evaluate the safety, tolerability, efficacy and pharmacokinetic/pharmacodynamic characteristics of SIM0613 in participants with locally advanced/ metastatic solid tumors. The study starts with a dose escalation part (Part 1) followed by a dose expansion part (Part 2).
- Conditions
- Advanced Solid Cancer
- Being tested
- SIM0613
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SIM0613Drug
Administered as an intravenous infusion in dosing cycles
SIM0613Drug
Administered as an intravenous infusion in dosing cycles
| Study group | Role | What they receive |
|---|---|---|
| A dose escalation of SIM0613 | Experimental | Not described Receives: Drug: SIM0613 |
| A dose expansion of SIM0613 in several different solid tumors | Experimental | Not described Receives: Drug: SIM0613 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose escalation: Safety and tolerability
Safety and tolerability：Number of participants with treatment-related adverse events as assessed by CTCAE v6.0，including laboratory values, vital signs, and electrocardiograms (ECGs), etc；AE related dose modifications(interruption, reduction and discontinuation) , etc
Measured: 2 years
Dose escalation：Dose -limiting toxicity (DLT)
Measured: The first 21 days after the first dose of study treatment
Dose expansion：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 posted1 Jun 2026
- Study start15 May 2026
- Primary completionJun 2028 (estimated)
- Study completionDec 2028 (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
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 294 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
- NCT07618260
- Sponsor's protocol ID
- SIM0613-101
- Acronym
- SIM0613-101
- Status last verified
- May 2026
- First submitted
- 19 May 2026
- Last updated
- 1 Jun 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 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I First-in-human, Open-label, Multicenter Study to Investigate the Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of SIM0613 in Participants With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT07618260
- Acronym / sponsor ID
- SIM0613-101 / SIM0613-101
- Conditions
- Advanced Solid Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 294 participants (estimated)
- Lead sponsor
- Jiangsu Simcere Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Shanghai Xianwei Medical Technology Co., Ltd.
- Study start
- 15 May 2026 (actual)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 1 Jun 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, efficacy and pharmacokinetic/pharmacodynamic characteristics of SIM0613 in participants with locally advanced/ metastatic solid tumors. The study starts with a dose escalation part (Part 1) followed by a dose expansion part (Part 2).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A dose escalation of SIM0613 | Experimental | Drug: SIM0613 |
| A dose expansion of SIM0613 in several different solid tumors | Experimental | Drug: SIM0613 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Written informed consent (ICF) is obtained prior to any of the specified procedures required for the study
- ≥18 years of age
- Histologically or cytologically confirmed locally advanced/metastatic solid tumors
- Have at least one measurable disease per RECIST Version 1.1 criteria
- Have experienced disease progression on/after at least one accessible standard therapy, or are intolerant to standard therapy, or are not suitable for standard therapy, or for whom clinical trial of the investigational drug serves as standard treatment
Key exclusion criteria (17 listed)
- Any other malignancy within 2 years prior to the first dose of the study treatment except for localized cancers that are considered to have been cured and in the opinion of the Investigator present a low risk for recurrence (e.g., basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix or breast)
- Participants with symptomatic central nervous system (CNS) metastases, or CNS metastases requiring CNS-directed local therapy (such as radiotherapy or surgery), or CNS metastases requiring corticosteroids therapy within 2 weeks of first dose of study treatment.
- History of bowel obstruction within 3 months prior to the first dose of study treatment.
- Known psychiatric disorder or drug abuse that would interfere the study requirements
- Uncontrollable pleural effusion, pericardial effusion, or ascites requiring drainage or medical intervention within 4 weeks before the first dose of 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 |
|---|---|---|
| SIM0613Administered as an intravenous infusion in dosing cycles | Drug | A dose escalation of SIM0613 |
| SIM0613Administered as an intravenous infusion in dosing cycles | Drug | A dose expansion of SIM0613 in several different solid tumors |
Primary outcome
Dose escalation: Safety and tolerability
Time frame: 2 years
Safety and tolerability：Number of participants with treatment-related adverse events as assessed by CTCAE v6.0，including laboratory values, vital signs, and electrocardiograms (ECGs), etc；AE related dose modifications(interruption, reduction and discontinuation) , etc
Dose escalation：Dose -limiting toxicity (DLT)
Time frame: The first 21 days after the first dose of study treatment
Dose expansion：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 1 Jun 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SIM0613 in people with Advanced Solid Cancer, run by Jiangsu Simcere Pharmaceutical Co., Ltd. at 1 site 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 17 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 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Qiuping Huang, Master (+86 021-58831288, huangqiuping@zaiming.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose escalation: Safety and tolerability (time frame: 2 years). 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 1 Jun 2026.