Advanced Solid TumorsPhase 1NCT06331559
Study of SIM0501 Alone and in Combination in Patients With Advanced Solid Tumors
A Phase 1 study testing SIM0501 Tablets and SIM0501 in combination with olaparib in people with Advanced Solid Tumors, run by Jiangsu Simcere Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
This is an open-label, multicenter Phase 1 clinical trial to evaluate the safety and tolerability, efficacy, and pharmacokinetics of SIM0501 in participants with advanced solid tumors. The trial consists two parts, Part 1 for SIM0501 monotherapy and Part 2 for SIM0501 in combination with olaparib. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumors
- What is being tested?
- SIM0501 Tablets and SIM0501 in combination with olaparib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteChina
- Study dates
- 19 Mar 2024to 17 Sep 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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.
- Aged ≥18 years, male or female.
- Patients who have histologically confirmed advanced/metastatic solid tumors that meet the following 3 criteria: 1) progressed on at least one prior systematic anti-tumor regimen; 2) have no standard of care (SOC), or are intolerant to SOC, or have no access to SOC; 3) with documented/locally confirmed deleterious or suspected deleterious germline or somatic BRCAm, HRRm or HRD.
- Has at least one evaluable (described below) or measurable tumor lesion according to RECIST v1.1 , and tumor lesions previously treated with radiotherapy or local therapy should be excluded as measurable lesions unless disease progression has been demonstrated. Palliative radiation therapy is allowed if there are non-radiated measurable disease in other organs.
- Eastern Cooperative Oncology Group (ECOG) score of 0 or 1.
- Expected survival ≥12 weeks.
Who cannot join
- Patients unable to swallow study drug and patients with gastrointestinal disorders likely to interfere with absorption of the study drug.
- Patient has not recovered (i.e., to Grade 1 or to baseline) from previous anticancer therapy-induced AEs.
- Note: Grade ≤2 AEs with no impact on patient safety are exceptions to this criterion and may qualify for the trial, e.g., Grade ≤2 hair loss and neuropathy caused by chemotherapy.
- Patient is currently participating or has participated in a trial of an investigational agent or using an investigational device within 4 weeks prior to the first dose of SIM0501, including but not limited to chemotherapy, radiotherapy, target therapy, immunotherapy or other anti-cancer therapies. Note: This does not include participation in the survival follow-up of a trial.
- Known human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS).
- Active hepatitis B (HBsAg or HBcAb positive and HBV DNA ≥1×104 copies/mL or ≥2000 international unit [IU]/mL) or hepatitis C (HCV antibody positive and HCV RNA ≥ ULN) infection; participant with HBsAg positive or detective HBV-DNA at screening should receive antiviral treatment as per local practice during the trial.
- Any other diseases, active or uncontrolled pulmonary dysfunction, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug, that may affect the interpretation of the results, or that renders the patient at high risk from treatment complications.
- Patient is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I First-in-human, Open-label Trial to Investigate the Safety, Pharmacokinetics and Antitumor Activity of SIM0501 as Monotherapy and in Combination in Participants With Advanced Solid Tumors
This is an open-label, multicenter Phase 1 clinical trial to evaluate the safety and tolerability, efficacy, and pharmacokinetics of SIM0501 in participants with advanced solid tumors. The trial consists two parts, Part 1 for SIM0501 monotherapy and Part 2 for SIM0501 in combination with olaparib. In both parts, SIM0501 with/without olaparib will be administered until disease progression or the investigator determines that continuation of the study drug would not benefit, or there is intolerable toxicity, or the participant or legal representative voluntarily requests withdrawal, or the trial is terminated.
- Conditions
- Advanced Solid Tumors
- Being tested
- SIM0501 Tablets, SIM0501 in combination with olaparib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SIM0501 TabletsDrug
Every 28 days is one cycle. Multiple dose levels of SIM0501 will be explored in dose escalation, and determine the maximum tolerated dose.
SIM0501 TabletsDrug
Every 28 days is one cycle.Patients will be administered a potential recommended dose of SIM0501 established from SIM0501 mono dose escalation.
SIM0501 in combination with olaparibDrug
Every 28 days is one cycle.Multiple dose levels of SIM0501 and olaparib will be explored in dose escalation, and determine the maximum tolerated dose.
SIM0501 in combination with olaparibDrug
Every 28 days is one cycle.Patients will be administered a potential recommended dose of SIM0501 combination with olaparib established from SIM0501 combination dose escalation.
| Study group | Role | What they receive |
|---|---|---|
| SIM0501 mono dose escalation | Experimental | Not described Receives: Drug: SIM0501 Tablets |
| SIM0501 mono dose optimization | Experimental | Not described Receives: Drug: SIM0501 Tablets |
| SIM0501 combination dose escalation | Experimental | Not described Receives: Drug: SIM0501 in combination with olaparib |
| SIM0501 combination dose optimization | Experimental | Not described Receives: Drug: SIM0501 in combination with olaparib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-limiting toxicity (DLT)
Primary Endpoints
Measured: At the end of Cycle 1 (each cycle is 28 days)
Adverse events will be evaluated according to the CTCAE v5.0
Primary Endpoints
Measured: The informed consent is signed until 30 days after the last dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2024
- Study start19 Mar 2024
- Primary completion17 Sep 2025
- Study completion17 Sep 2025
Why it stopped: Company development strategy change
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu Simcere Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Shanghai Xianxiang Medical Technology Co., Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06331559
- Sponsor's protocol ID
- SIM0501-101
- Status last verified
- Feb 2026
- First submitted
- 13 Mar 2024
- Last updated
- 9 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I First-in-human, Open-label Trial to Investigate the Safety, Pharmacokinetics and Antitumor Activity of SIM0501 as Monotherapy and in Combination in Participants With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT06331559
- Acronym / sponsor ID
- SIM0501-101
- Conditions
- Advanced Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Company development strategy change
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Jiangsu Simcere Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Shanghai Xianxiang Medical Technology Co., Ltd.
- Study start
- 19 Mar 2024 (actual)
- Primary completion
- 17 Sep 2025 (actual)
- Study completion
- 17 Sep 2025 (actual)
- First posted
- 26 Mar 2024 (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 clinical trial to evaluate the safety and tolerability, efficacy, and pharmacokinetics of SIM0501 in participants with advanced solid tumors. The trial consists two parts, Part 1 for SIM0501 monotherapy and Part 2 for SIM0501 in combination with olaparib. In both parts, SIM0501 with/without olaparib will be administered until disease progression or the investigator determines that continuation of the study drug would not benefit, or there is intolerable toxicity, or the participant or legal representative voluntarily requests withdrawal, or the trial is terminated.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| SIM0501 mono dose escalation | Experimental | Drug: SIM0501 Tablets |
| SIM0501 mono dose optimization | Experimental | Drug: SIM0501 Tablets |
| SIM0501 combination dose escalation | Experimental | Drug: SIM0501 in combination with olaparib |
| SIM0501 combination dose optimization | Experimental | Drug: SIM0501 in combination with olaparib |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Voluntary participation and signature of informed consent form.
- Aged ≥18 years, male or female.
- Patients who have histologically confirmed advanced/metastatic solid tumors that meet the following 3 criteria: 1) progressed on at least one prior systematic anti-tumor regimen; 2) have no standard of care (SOC), or are intolerant to SOC, or have no access to SOC; 3) with documented/locally confirmed deleterious or suspected deleterious germline or somatic BRCAm, HRRm or HRD.
- Has at least one evaluable (described below) or measurable tumor lesion according to RECIST v1.1 , and tumor lesions previously treated with radiotherapy or local therapy should be excluded as measurable lesions unless disease progression has been demonstrated. Palliative radiation therapy is allowed if there are non-radiated measurable disease in other organs.
- Eastern Cooperative Oncology Group (ECOG) score of 0 or 1.
Key exclusion criteria (8 listed)
- Patients unable to swallow study drug and patients with gastrointestinal disorders likely to interfere with absorption of the study drug.
- Patient has not recovered (i.e., to Grade 1 or to baseline) from previous anticancer therapy-induced AEs.
- Note: Grade ≤2 AEs with no impact on patient safety are exceptions to this criterion and may qualify for the trial, e.g., Grade ≤2 hair loss and neuropathy caused by chemotherapy.
- Patient is currently participating or has participated in a trial of an investigational agent or using an investigational device within 4 weeks prior to the first dose of SIM0501, including but not limited to chemotherapy, radiotherapy, target therapy, immunotherapy or other anti-cancer therapies. Note: This does not include participation in the survival follow-up of a trial.
- Known human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS).
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 |
|---|---|---|
| SIM0501 TabletsEvery 28 days is one cycle. Multiple dose levels of SIM0501 will be explored in dose escalation, and determine the maximum tolerated dose. | Drug | SIM0501 mono dose escalation |
| SIM0501 TabletsEvery 28 days is one cycle.Patients will be administered a potential recommended dose of SIM0501 established from SIM0501 mono dose escalation. | Drug | SIM0501 mono dose optimization |
| SIM0501 in combination with olaparibEvery 28 days is one cycle.Multiple dose levels of SIM0501 and olaparib will be explored in dose escalation, and determine the maximum tolerated dose. | Drug | SIM0501 combination dose escalation |
| SIM0501 in combination with olaparibEvery 28 days is one cycle.Patients will be administered a potential recommended dose of SIM0501 combination with olaparib established from SIM0501 combination dose escalation. | Drug | SIM0501 combination dose optimization |
Primary outcome
Dose-limiting toxicity (DLT)
Time frame: At the end of Cycle 1 (each cycle is 28 days)
Primary Endpoints
Adverse events will be evaluated according to the CTCAE v5.0
Time frame: The informed consent is signed until 30 days after the last dosing
Primary Endpoints
Results and safety
The study was stopped early (reason given: Company development strategy change). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2026.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 SIM0501 Tablets and SIM0501 in combination with olaparib in people with Advanced Solid Tumors, 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 6 inclusion and 8 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: stopped early, as of the sponsor's last update on 9 Feb 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?
The study was stopped early (reason given: Company development strategy change). Results are not available in the source record.
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?
Dose-limiting toxicity (DLT) (time frame: At the end of Cycle 1 (each cycle is 28 days)). The study lists 2 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 9 Feb 2026.