Locally Advanced Solid TumorsPhase 1NCT07050459
A Phase I Study of SIM0686 in Participants With Locally Advanced/Metastatic Solid Tumors
A Phase 1 study testing SIM0686 in people with Locally Advanced Solid Tumors, run by Jiangsu Simcere Pharmaceutical Co., Ltd. at 10 sites in China.
Trial summary
This is an open-label, multicenter phase 1 study to evaluate the safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of SIM0686 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
- Locally Advanced Solid Tumors
- What is being tested?
- SIM0686
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 10 sitesChina
- Study dates
- 20 May 2025to 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
- 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 (RECIST v1.1);
- 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 6 months before first administration for evaluation of FGFR2b expression levels
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.
- Participant has symptomatic central nervous system (CNS) metastases, or CNS metastases requiring CNS-directed local therapy (such as radiotherapy or surgery) or corticosteroids therapy within 2 weeks of first dose of study treatment.
- Active or chronic corneal disorder, history of corneal transplantation, keratitis, keratoconjunctivitis, keratopathy, keratoconus, corneal abrasion, inflammation or ulceration, other active ocular conditions and any clinically significant corneal disease that prevents adequate monitoring of drug-induced keratopathy.
- 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.
- Participant has not recovered (i.e., to Grade 1 or to baseline) from previous anticancer therapy-induced AEs.
- Has received prior therapies within the following time frames prior to the first dose of study treatment:
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- Previous cytotoxic therapy, anticancer targeted small molecules (e.g., tyrosine kinase inhibitors) 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 FGFR2b-targeted ADC therapies.
- Known human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS).
- Active or chronic hepatitis B or hepatitis C infection;
Trial locations and contacts
10 sites in 1 country. Contact the study team or a site near you to ask about taking part.
10 sites in 1 country
China10 sites, 10 recruiting
- Not yet recruiting
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100021
Jie Wang, PHD, +8613910704669, zlhuxi@163.com
- Not yet recruiting
Hunan Cancer Hospital
Changsha, Hunan, 410017
Zhenyang Liu, PHD, +8618673181133, liuzhenyang@hnca.org.cn
- Recruiting
Sichuan Cancer Hospital
Chengdu, Sichuan, 610040
Tongyu Lin, PHD, +8613926400320, lintongyu@scszlyy.org.cn
- Not yet recruiting
Harbin Medical University Cancer Hospital
Haerbin, Heilongjiang, 150081
Tongsen Zheng, PHD, +8615134569619, yqbfzhengtongsen@163.com
Yan Yu, PHD
- Not yet recruiting
Cancer Hospital of Shandong First Medical University（Shandong Cancer Hospital&Institute）
Jinan, Shandong, 250117
Shuqin Ni, PHD, +8615553115936, nsq163@163.com
- Recruiting
Nanjing Tianyinshan Hospital
Nanjing, Jiangsu, 210008
Shukui Qin, PHD, +8613905158713, qinsk81@163.com
- Not yet recruiting
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
Jian Zhang, PHD, +8618017312991, syner2000@163.com
- Recruiting
Shanghai Gobroad Cancer Hospital
Shanghai, Shanghai Municipality, 200131
Jin Lin, PHD, +8613761222111, jin.li@gobroadhealthcare.com
- Not yet recruiting
Tianjin Cancer Hospital
Tianjin, Tianjin Municipality, 300060
Ting Deng, PHD, +8615802243063, xymcdengting@126.com
- Not yet recruiting
The Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital
Zhengzhou, Henan, 450003
Qiming Wang, PHD, +8613783590691, qimingwang1006@126.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 SIM0686 in Adult Participants With Locally Advanced/Metastatic Solid Tumors
This is an open-label, multicenter phase 1 study to evaluate the safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of SIM0686 in Adult Participants with Locally Advanced/Metastatic Solid Tumors
- Conditions
- Locally Advanced Solid Tumors
- Being tested
- SIM0686
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SIM0686Drug
Administered intravenously
SIM0686Drug
Administered intravenously
| Study group | Role | What they receive |
|---|---|---|
| SIM0686 momo Dose escalation | Experimental | Sequential cohorts of increasing dose levels of SIM0686 will be evaluated as monotherapy Receives: Drug: SIM0686 |
| SIM0686 Corhort expansion | Experimental | Recommended Dose(s) of SIM0686 as determined from Part1 will be evaluated in select indications Receives: Drug: SIM0686 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose escalation: Dose limited toxicity (DLT)
DLTs are assessed during the DLT observation period to determine maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D).
Measured: At the end of Cycle 1(each cycle is 21 days)
Dose escalation phase: Adverse Events (AEs) and Serious Adverse Events (SAEs)
Adverse events will be assessed by investigator(s) according to NCI-CTCAE v5.0.
Measured: The whole dose escalation phase，an average of 2 years
Cohort expansion phase：Overall Response Rate (ORR)
ORR is defined as the percentage of participants with confirmed complete response (CR) or partial response (PR) by Response Evaluations Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
Measured: The whole Cohort expansion phase，an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2025
- Study start20 May 2025
- Primary completionDec 2027 (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 Locally Advanced Solid TumorsStudies 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
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu Simcere Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07050459
- Sponsor's protocol ID
- SIM0686-101
- Status last verified
- Jul 2025
- First submitted
- 27 May 2025
- Last updated
- 3 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2025. 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 SIM0686 in Adult Participants With Locally Advanced/Metastatic Solid Tumors
- ClinicalTrials.gov ID
- NCT07050459
- Acronym / sponsor ID
- SIM0686-101
- Conditions
- Locally Advanced Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Jiangsu Simcere Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 20 May 2025 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 3 Jul 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 1 study to evaluate the safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of SIM0686 in Adult Participants with Locally Advanced/Metastatic Solid Tumors
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SIM0686 momo Dose escalation | Experimental | Drug: SIM0686Sequential cohorts of increasing dose levels of SIM0686 will be evaluated as monotherapy |
| SIM0686 Corhort expansion | Experimental | Drug: SIM0686Recommended Dose(s) of SIM0686 as determined from Part1 will be evaluated in select indications |
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 (RECIST v1.1);
- Participants have failed the standard of therapy in the locally advanced/metastatic setting
Key exclusion criteria (13 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.
- Participant has symptomatic central nervous system (CNS) metastases, or CNS metastases requiring CNS-directed local therapy (such as radiotherapy or surgery) or corticosteroids therapy within 2 weeks of first dose of study treatment.
- Active or chronic corneal disorder, history of corneal transplantation, keratitis, keratoconjunctivitis, keratopathy, keratoconus, corneal abrasion, inflammation or ulceration, other active ocular conditions and any clinically significant corneal disease that prevents adequate monitoring of drug-induced keratopathy.
- 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.
- Participant has not recovered (i.e., to Grade 1 or to baseline) from previous anticancer therapy-induced AEs.
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 |
|---|---|---|
| SIM0686Administered intravenously | Drug | SIM0686 Corhort expansion |
| SIM0686Administered intravenously | Drug | SIM0686 momo Dose escalation |
Primary outcome
Dose escalation: Dose limited toxicity (DLT)
Time frame: At the end of Cycle 1(each cycle is 21 days)
DLTs are assessed during the DLT observation period to determine maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D).
Dose escalation phase: Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: The whole dose escalation phase，an average of 2 years
Adverse events will be assessed by investigator(s) according to NCI-CTCAE v5.0.
Cohort expansion phase：Overall Response Rate (ORR)
Time frame: The whole Cohort expansion phase，an average of 2 years
ORR is defined as the percentage of participants with confirmed complete response (CR) or partial response (PR) by Response Evaluations Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
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 3 Jul 2025.
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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.
10 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 SIM0686 in people with Locally Advanced Solid Tumors, run by Jiangsu Simcere Pharmaceutical Co., Ltd. at 10 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 13 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 3 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 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 Zhi Zhang (+8618670738874, zhangzhi4@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 limited toxicity (DLT) (time frame: At the end of Cycle 1(each cycle is 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 3 Jul 2025.