Breast CancerPhase 1NCT05293964
Phase I Study to Evaluate SIM0270 Alone or in Combination in ER+, HER2- Locally Advanced or Metastatic Breast Cancer
A Phase 1 study testing SIM0270, Palbociclib and everolimus in people with Breast Cancer, run by Jiangsu Simcere Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
This study is a multi-center, open-label, Phase 1 clinical study to evaluate the safety, pharmacokinetic (PK) and anti-tumor efficacy of SIM0270 and SIM0270 in combination with palbociclib or everolimus in subjects with estrogen receptor (ER) -positive, human epidermal growth factor receptor (HER-2) -negative locally… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- SIM0270, Palbociclib and everolimus
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 214 participants
- Where
- 1 siteChina
- Study dates
- 18 May 2022to 8 Sep 2025
- 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 in clinical trials and signature of informed consent.
- age ≥ 18 years, male or female.
- Histologically or cytologically confirmed metastatic/locally advanced ER-positive, HER-2 negative breast cancer subjects.
- previous treatment meets the criteria of the protocol defined.
- ECOG score of 0 or 1 .
- at least one measurable lesion that meets RECISTv1.1 criteria. Osteolytic lesions can be included in the Ia dose-escalating .
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- expected survival ≥ 12 weeks.
- Adequate organ and bone marrow function.
- Women of childbearing potential must have a negative serum pregnancy test within 7 days prior to the first dose.
- Postmenopausal women; Premenopausal or perimenopausal female subjects met protocol requirements.
Who cannot join
- Documented medical history or ongoing gastrointestinal disease or other malabsorption that may affect the absorption of oral study drug.
- Participated in other clinical trials of investigational drugs or investigational devices within 28 days before the first medication; or received chemotherapy, targeted therapy, immunotherapy and clinical trial medication and other anti-tumor treatment within 4 days or 5 half-lives of the first medication (whichever is shorter), or received radiotherapy, endocrine drugs or Chinese patent medicines with anti-tumor indications 2 weeks before the first medication;
- The toxicity of previous anti-tumor treatment has not recovered to grade 0 or 1 (alopecia, chemotherapy-induced peripheral neurotoxicity ≤ grade 2 can be included).
- Major surgical surgery (except biopsy) or incomplete healing of the surgical incision 4 times before the first study drug treatment;
- Known other malignant tumors within 2 years before enrollment (except treated basal cell carcinoma, scaly cell carcinoma and/or radical carcinoma in situ);
- Leptomeningeal metastasis confirmed by MRI or known cytology of CSF, or cranial Increased internal pressure or brain metastases with unstable central nervous symptoms (within 2 weeks prior to initial medication Treatment with any craniotropic, glucocorticokinin, or anticonvulsant);
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- Previous history of interstitial lung disease, drug-induced interstitial lung disease, symptomatic interstitial lung disease or any evidence of active pneumonia on chest CT scan 4 before the first study drug treatment;
- known to interfere with the test requirements of mental illness or drug abuse disease.
- History of human immunodeficiency virus HIV infection, or active bacterial or fungal infection requiring systemic treatment .
- presence of active syphilis infection.
- Subjects with known active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection with abnormal liver function.
- History of clinically significant cardiovascular disease.
- History of serious allergic reactions to the study drugs or excipients used in the protocol.
- Women who are pregnant or lactating.
- Prior use of SERD oral medications.
- Subjects who use drugs or herbal supplements known to be moderate/strong inhibitors of CYP3A 2 Weeks before the first dose.Or Subjects who use drugs or herbal supplements known to be moderate/strong inducers of CYP3A 4 weeks before the first dose.
- Other conditions that the investigator considers unsuitable for this study.
Trial locations and contacts
1 site in 1 country.
China1 site
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality
About this study
Official title: A Multicenter, Open-label, Phase I Clinical Study to Evaluate the Safety, Pharmacokinetics, and Antitumor Efficacy of SIM0270 Alone or in Combination in Subjects with ER-positive, HER-2 Negative Locally Advanced or Metastatic Breast Cancer
This study is a multi-center, open-label, Phase 1 clinical study to evaluate the safety, pharmacokinetic (PK) and anti-tumor efficacy of SIM0270 and SIM0270 in combination with palbociclib or everolimus in subjects with estrogen receptor (ER) -positive, human epidermal growth factor receptor (HER-2) -negative locally advanced or metastatic breast cancer.
Read the detailed description
The study is comprised of two parts: Phase Ia and Phase Ib. Phase Ia includes dose-escalating stage and dose expansion stageof SIM0270 monotherapy to determine the MTD/ RP2D and the preliminary safety and efficacy of SIM0270; Phase Ib includes 2 arms, armA: dose escalation and dose expansion of SIM0270 in combination with palbociclib; armB: dose escalation and dose expansion of SIM0270 in combination with palbociclib everolimus; phase Ib is designed to determine the MTD/RP2D and the preliminary safety and efficacy of SIM0270 in combination with palbociclib or everolimus.
- Conditions
- Breast Cancer
- Being tested
- SIM0270, Palbociclib, everolimus
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SIM0270Drug
Also called SCR6852
SIM0270 is an oral, selective estrogen receptor degrader (SERD)
PalbociclibDrug
palbociclib is a selective inhibitor of cyclin D-cyclin-dependent kinase (CDK) 4/6
everolimusDrug
Everolimus is an inhibitor of mTOR (mammalian target of rapamycin)
| Study group | Role | What they receive |
|---|---|---|
| SIM0270 | Experimental | Phase Ia SIM0270 monotherapy dose escalation and expansion Receives: Drug: SIM0270 |
| SIM0270+palbociclib | Experimental | Phase Ib SIM0270 with palbociclib dose escalation and expansion Receives: Drug: SIM0270; Drug: Palbociclib |
| SIM0270+everolimus | Experimental | Phase Ib SIM0270 with everolimus dose escalation and expansion Receives: Drug: SIM0270; Drug: everolimus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose
Dose Escalation: Maximum Tolerated Dose (MTD) of SIM0270 When Administered as a Single Agent or in Combination with Palbociclib or Everolimus
Measured: At the end of Cycle 1 (each cycle is 28 days)
recommended phase 2 Dose
Dose Escalation: recommended phase 2 Dose (RP2D) of SIM0270 When Administered as a Single Agent or in Combination with Palbociclib or Everolimus
Measured: At the end of Cycle 1 (each cycle is 28 days)
Dose-Limiting Toxicities
Dose Escalation: Number of Participants with Dose-Limiting Toxicities When SIM0270 is Administered as a Single Agent or in Combination with Palbociclib or Everolimus
Measured: At the end of Cycle 1 (each cycle is 28 days)
Secondary outcomes (12)
Adverse event
Number of Participants with Adverse Events by Severity, According to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI-CTCAE v5.0)
Measured: From Baseline until 30 days after the last dose of study treatment
Peak Plasma Concentration (Cmax) of SIM0270 as monotherapy or combination with palbociclib or everolimus
Peak Plasma Concentration (Cmax)
Measured: At the end of Cycle 4 (each cycle is 28 days)
Time of Peak Plasma Concentration (Tmax) of SIM0270 as monotherapy or combination with palbociclib or everolimus
Time of Peak Plasma Concentration (Tmax)
Measured: At the end of Cycle 4 (each cycle is 28 days)
Area under the plasma concentration versus time curve (AUC) of SIM0270 as monotherapy or combination with palbociclib or everolimus
Area under the plasma concentration versus time curve (AUC)
Measured: At the end of Cycle 4 (each cycle is 28 days)
clinical benefit rate
Antitumour activity by evaluation of clinical benefit rate assessments using Response Evaluation Criteria in breast cancer (RECIST 1.1)or Response Assessment in Neuro-Oncology Brain Metastases (RANO-BM)
Measured: through study completion, an average of 1 year
disease control rate
Antitumour activity by evaluation of disease control rate assessments using Response Evaluation Criteria in breast cancer (RECIST 1.1)or Response Assessment in Neuro-Oncology Brain Metastases (RANO-BM)
Measured: through study completion, an average of 1 year
duration of response
Antitumour activity by evaluation of duration of response assessments using Response Evaluation Criteria in breast cancer (RECIST 1.1)or Response Assessment in Neuro-Oncology Brain Metastases (RANO-BM)
Measured: through study completion, an average of 1 year
progression free survival
Antitumour activity by evaluation of progression free survival assessments using Response Evaluation Criteria in breast cancer (RECIST 1.1)or Response Assessment in Neuro-Oncology Brain Metastases (RANO-BM)
Measured: From date of C1D1 until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
time to progression
Antitumour activity by evaluation of time to progression assessments using Response Evaluation Criteria in breast cancer (RECIST 1.1)or Response Assessment in Neuro-Oncology Brain Metastases (RANO-BM)
Measured: From date of C1D1 until the date of first documented progression, assessed up to100 months
time to response
Antitumour activity by evaluation of time to response assessments using Response Evaluation Criteria in breast cancer (RECIST 1.1)or Response Assessment in Neuro-Oncology Brain Metastases (RANO-BM)
Measured: through study completion, an average of 1 year
overall survival
Antitumour activity by evaluation of overall survival assessments
Measured: From date of C1D1 until the date of death from any cause, assessed up to 100 months
overall response rate
Antitumour activity by evaluation of tumour response assessments using Response Evaluation Criteria in breast cancer (RECIST 1.1)
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2022
- Study start18 May 2022
- Primary completion31 Dec 2024 (estimated)
- Study completion8 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- 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
- 214 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu Simcere Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Nanjing Zaiming Pharmaceutical Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Jiong Wu, phD, Principal investigator, chief physician
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05293964
- Sponsor's protocol ID
- SIM-1907-02-SERD-101
- Status last verified
- Nov 2024
- First submitted
- 7 Mar 2022
- Last updated
- 29 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: the plan to make individual participant data (IPD) available to other researchers is not decided yet.
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-label, Phase I Clinical Study to Evaluate the Safety, Pharmacokinetics, and Antitumor Efficacy of SIM0270 Alone or in Combination in Subjects with ER-positive, HER-2 Negative Locally Advanced or Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT05293964
- Acronym / sponsor ID
- SIM-1907-02-SERD-101
- Conditions
- Breast Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 214 participants (actual)
- Lead sponsor
- Jiangsu Simcere Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Nanjing Zaiming Pharmaceutical Co., Ltd.
- Study start
- 18 May 2022 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 8 Sep 2025 (estimated)
- First posted
- 24 Mar 2022 (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 study is a multi-center, open-label, Phase 1 clinical study to evaluate the safety, pharmacokinetic (PK) and anti-tumor efficacy of SIM0270 and SIM0270 in combination with palbociclib or everolimus in subjects with estrogen receptor (ER) -positive, human epidermal growth factor receptor (HER-2) -negative locally advanced or metastatic breast cancer.
Detailed description
The study is comprised of two parts: Phase Ia and Phase Ib. Phase Ia includes dose-escalating stage and dose expansion stageof SIM0270 monotherapy to determine the MTD/ RP2D and the preliminary safety and efficacy of SIM0270; Phase Ib includes 2 arms, armA: dose escalation and dose expansion of SIM0270 in combination with palbociclib; armB: dose escalation and dose expansion of SIM0270 in combination with palbociclib everolimus; phase Ib is designed to determine the MTD/RP2D and the preliminary safety and efficacy of SIM0270 in combination with palbociclib or everolimus.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| SIM0270 | Experimental | Drug: SIM0270Phase Ia SIM0270 monotherapy dose escalation and expansion |
| SIM0270+palbociclib | Experimental | Drug: SIM0270, Drug: PalbociclibPhase Ib SIM0270 with palbociclib dose escalation and expansion |
| SIM0270+everolimus | Experimental | Drug: SIM0270, Drug: everolimusPhase Ib SIM0270 with everolimus dose escalation and expansion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- voluntary participation in clinical trials and signature of informed consent.
- age ≥ 18 years, male or female.
- Histologically or cytologically confirmed metastatic/locally advanced ER-positive, HER-2 negative breast cancer subjects.
- previous treatment meets the criteria of the protocol defined.
- ECOG score of 0 or 1 .
Key exclusion criteria (17 listed)
- Documented medical history or ongoing gastrointestinal disease or other malabsorption that may affect the absorption of oral study drug.
- Participated in other clinical trials of investigational drugs or investigational devices within 28 days before the first medication; or received chemotherapy, targeted therapy, immunotherapy and clinical trial medication and other anti-tumor treatment within 4 days or 5 half-lives of the first medication (whichever is shorter), or received radiotherapy, endocrine drugs or Chinese patent medicines with anti-tumor indications 2 weeks before the first medication;
- The toxicity of previous anti-tumor treatment has not recovered to grade 0 or 1 (alopecia, chemotherapy-induced peripheral neurotoxicity ≤ grade 2 can be included).
- Major surgical surgery (except biopsy) or incomplete healing of the surgical incision 4 times before the first study drug treatment;
- Known other malignant tumors within 2 years before enrollment (except treated basal cell carcinoma, scaly cell carcinoma and/or radical carcinoma in situ);
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 |
|---|---|---|
| SIM0270Also: SCR6852SIM0270 is an oral, selective estrogen receptor degrader (SERD) | Drug | SIM0270, SIM0270+everolimus, SIM0270+palbociclib |
| Palbociclibpalbociclib is a selective inhibitor of cyclin D-cyclin-dependent kinase (CDK) 4/6 | Drug | SIM0270+palbociclib |
| everolimusEverolimus is an inhibitor of mTOR (mammalian target of rapamycin) | Drug | SIM0270+everolimus |
Primary outcome
Maximum Tolerated Dose
Time frame: At the end of Cycle 1 (each cycle is 28 days)
Dose Escalation: Maximum Tolerated Dose (MTD) of SIM0270 When Administered as a Single Agent or in Combination with Palbociclib or Everolimus
recommended phase 2 Dose
Time frame: At the end of Cycle 1 (each cycle is 28 days)
Dose Escalation: recommended phase 2 Dose (RP2D) of SIM0270 When Administered as a Single Agent or in Combination with Palbociclib or Everolimus
Dose-Limiting Toxicities
Time frame: At the end of Cycle 1 (each cycle is 28 days)
Dose Escalation: Number of Participants with Dose-Limiting Toxicities When SIM0270 is Administered as a Single Agent or in Combination with Palbociclib or Everolimus
12 secondary outcomes
Adverse event
Time frame: From Baseline until 30 days after the last dose of study treatment
Peak Plasma Concentration (Cmax) of SIM0270 as monotherapy or combination with palbociclib or everolimus
Time frame: At the end of Cycle 4 (each cycle is 28 days)
Time of Peak Plasma Concentration (Tmax) of SIM0270 as monotherapy or combination with palbociclib or everolimus
Time frame: At the end of Cycle 4 (each cycle is 28 days)
Area under the plasma concentration versus time curve (AUC) of SIM0270 as monotherapy or combination with palbociclib or everolimus
Time frame: At the end of Cycle 4 (each cycle is 28 days)
clinical benefit rate
Time frame: through study completion, an average of 1 year
disease control rate
Time frame: through study completion, an average of 1 year
duration of response
Time frame: through study completion, an average of 1 year
progression free survival
Time frame: From date of C1D1 until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
time to progression
Time frame: From date of C1D1 until the date of first documented progression, assessed up to100 months
time to response
Time frame: through study completion, an average of 1 year
overall survival
Time frame: From date of C1D1 until the date of death from any cause, assessed up to 100 months
overall response rate
Time frame: through study completion, an average of 1 year
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 29 Nov 2024.
- Individual participant dataSharing planned: No. the plan to make individual participant data (IPD) available to other researchers is not decided yet.
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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.
Jiong Wu, phD principal investigator
chief physician
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 SIM0270, Palbociclib and everolimus in people with Breast 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 10 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: under way, not looking for participants, as of the sponsor's last update on 29 Nov 2024. 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?
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?
Maximum Tolerated Dose (time frame: At the end of Cycle 1 (each cycle is 28 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 29 Nov 2024.