Histologically or Cytologically Confirmed Advanced Solid TumorsPhase 1NCT07749703
A Phase I Study of SIM0532 in Adult Participants With Advanced Solid Tumors
A Phase 1 study testing SIM0532 Tablets in people with Histologically or Cytologically Confirmed Advanced Solid Tumors, run by Jiangsu Simcere Pharmaceutical Co., Ltd. at 6 sites in China.
Trial summary
an open-label, multicenter, Phase I study designed to evaluate the safety, tolerability, efficacy, and pharmacokinetic/pharmacodynamic (PK/PD) characteristics of SIM0532 in participants with advanced solid tumors. The study commences with a dose-escalation part (Part 1), followed by a dose-expansion part (Part 2). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Histologically or Cytologically Confirmed Advanced Solid Tumors
- What is being tested?
- SIM0532 Tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 346 participants
- Where
- 6 sitesChina
- Study dates
- 31 Mar 2026to 30 Jun 2030
- 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
- 1. Signed the informed consent form prior to performing the specified procedures required by the study.
- 2. Aged ≥18 years.
- 3. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
- 4. Expected survival ≥12 weeks.
- 5. Laboratory test results indicating sufficient organ function.
- 6. At least one measurable lesion per RECIST v1.1;
Who cannot join
- 1. A history of other malignant tumors within 2 years.
- 2. With symptomatic central nervous system (CNS) metastases.
- 3. Gastrointestinal diseases that affect drug administration/absorption.
- 4. Known psychiatric disorders or substance abuse that may interfere with the conduct of the study.
- 5. Uncontrolled pleural effusion, pericardial effusion or ascites requiring drainage or medical intervention within 4 weeks.
- 6. Any active infection requiring systemic treatment within 2 weeks.
Show all 19Show fewer
- 7. A history of non-infectious pneumonia requiring oral or intravenous steroid therapy for recovery, or interstitial lung disease (ILD) or severe obstructive pulmonary disease.
- 8. Previous treatment with RAS-targeting therapies other than RAS (OFF) inhibitors.
- 9. Failure to recover from adverse events (AEs) caused by previous antineoplastic therapy.
- 10. Currently participating in or having participated in a study of other investigational drugs or devices within 4 weeks.
- 11. Major surgery within 4 weeks.
- 12. Previous antineoplastic therapy before the first dose of study treatment should have a certain wash-out period
- 13. Vaccination with any live vaccine within 4 weeks.
- 14. Known human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS).
- 15. Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection;
- 16. A history of clinically significant cardiovascular disease.
- 17. A history of allogeneic organ transplantation or graft-versus-host disease (GVHD).
- 18. Known hypersensitivity to the study drug or any of its excipients.
- 19. Participants who are pregnant or breastfeeding.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
China6 sites
Zhejiang Cancer Hospital
Hangzhou, Zhejiang
The First Affiliated Hospital of University of Science and Technology of China
Hefei, Anhui
Shandong Cancer Hospital and Institute
Jinan, Shandong
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality
The First Hospital of China Medical University
Shenyang, Liaoning
About this study
Official title: An Open-label, Multicenter, First-in-human Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of SIM0532 in Adult Participants With Advanced Solid Tumors
an open-label, multicenter, Phase I study designed to evaluate the safety, tolerability, efficacy, and pharmacokinetic/pharmacodynamic (PK/PD) characteristics of SIM0532 in participants with advanced solid tumors. The
study commences with a dose-escalation part (Part 1), followed by a dose-expansion part (Part 2).
Read the detailed description
Part 1 will be guided by the Bayesian Optimal Interval (BOIN) dose-escalation rule. In Part 2, patients with advanced pancreatic adenocarcinoma, RAS-mutant advanced non-small cell lung cancer (NSCLC) and other RAS-mutant advanced solid tumors.
- Being tested
- SIM0532 Tablets
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SIM0532 TabletsDrug
SIM0532 Tablets
| Study group | Role | What they receive |
|---|---|---|
| Oral SIM0532 | Experimental | Not described Receives: Drug: SIM0532 Tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part 1: Dose-limiting toxicity (DLT)
Measured: Cycle 1 Day 1 (C1D1) to Cycle 1 Day 21 (C1D21) (Each cycle is 21 days)
Part 1: Safety: Incidence and severity of adverse events (AEs) and serious adverse events (SAEs)
Measured: From informed consent signing to 30 days after the last dose
Part 2: Incidence and severity of subjects with AEs/SAEs
Measured: From informed consent signing to 30 days after the last dose
Part 2: Objective response rate (ORR)
Measured: About 24 months.
Secondary outcomes (6)
Maximum plasma concentration (Cmax)
Measured: About 24 months
Duration of response (DOR)
Measured: About 24 months
Disease control rate (DCR)
Measured: About 24 months
Time to response (TTR)
Measured: About 24 months
Overall survival (OS)
Measured: About 24 months
Progression-free survival (PFS)
Measured: About 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2026
- Study start31 Mar 2026
- Primary completion30 Jun 2028 (estimated)
- Study completion30 Jun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Histologically or Cytologically Confirmed 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 346 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
- NCT07749703
- Sponsor's protocol ID
- SIM0532-101
- Other IDs
- Center for drug Evaluation
- Status last verified
- Apr 2026
- First submitted
- 3 Aug 2026
- Last updated
- 11 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Multicenter, First-in-human Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of SIM0532 in Adult Participants With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT07749703
- Acronym / sponsor ID
- SIM0532-101
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 346 participants (estimated)
- Lead sponsor
- Jiangsu Simcere Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Shanghai Xianwei Medical Technology Co., Ltd.
- Study start
- 31 Mar 2026 (actual)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 30 Jun 2030 (estimated)
- First posted
- 6 Aug 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.
an open-label, multicenter, Phase I study designed to evaluate the safety, tolerability, efficacy, and pharmacokinetic/pharmacodynamic (PK/PD) characteristics of SIM0532 in participants with advanced solid tumors. The
study commences with a dose-escalation part (Part 1), followed by a dose-expansion part (Part 2).
Detailed description
Part 1 will be guided by the Bayesian Optimal Interval (BOIN) dose-escalation rule. In Part 2, patients with advanced pancreatic adenocarcinoma, RAS-mutant advanced non-small cell lung cancer (NSCLC) and other RAS-mutant advanced solid tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Oral SIM0532 | Experimental | Drug: SIM0532 Tablets |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 1. Signed the informed consent form prior to performing the specified procedures required by the study.
- 2. Aged ≥18 years.
- 3. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
- 4. Expected survival ≥12 weeks.
- 5. Laboratory test results indicating sufficient organ function.
Key exclusion criteria (19 listed)
- 1. A history of other malignant tumors within 2 years.
- 2. With symptomatic central nervous system (CNS) metastases.
- 3. Gastrointestinal diseases that affect drug administration/absorption.
- 4. Known psychiatric disorders or substance abuse that may interfere with the conduct of the study.
- 5. Uncontrolled pleural effusion, pericardial effusion or ascites requiring drainage or medical intervention within 4 weeks.
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 |
|---|---|---|
| SIM0532 TabletsSIM0532 Tablets | Drug | Oral SIM0532 |
Primary outcome
Part 1: Dose-limiting toxicity (DLT)
Time frame: Cycle 1 Day 1 (C1D1) to Cycle 1 Day 21 (C1D21) (Each cycle is 21 days)
Part 1: Safety: Incidence and severity of adverse events (AEs) and serious adverse events (SAEs)
Time frame: From informed consent signing to 30 days after the last dose
Part 2: Incidence and severity of subjects with AEs/SAEs
Time frame: From informed consent signing to 30 days after the last dose
Part 2: Objective response rate (ORR)
Time frame: About 24 months.
6 secondary outcomes
Maximum plasma concentration (Cmax)
Time frame: About 24 months
Duration of response (DOR)
Time frame: About 24 months
Disease control rate (DCR)
Time frame: About 24 months
Time to response (TTR)
Time frame: About 24 months
Overall survival (OS)
Time frame: About 24 months
Progression-free survival (PFS)
Time frame: About 24 months
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 11 Aug 2026.
- Individual participant dataSharing planned: Undecided
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 SIM0532 Tablets in people with Histologically or Cytologically Confirmed Advanced Solid Tumors, 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 6 inclusion and 19 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: under way, not looking for participants, as of the sponsor's last update on 11 Aug 2026. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Part 1: Dose-limiting toxicity (DLT) (time frame: Cycle 1 Day 1 (C1D1) to Cycle 1 Day 21 (C1D21) (Each cycle is 21 days)). The study lists 4 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 11 Aug 2026.