Status:
ACTIVE_NOT_RECRUITING
Phase I Study to Evaluate SIM0270 Alone or in Combination in ER+, HER2- Locally Advanced or Metastatic Breast Cancer
Lead Sponsor:
Jiangsu Simcere Pharmaceutical Co., Ltd.
Collaborating Sponsors:
Nanjing Zaiming Pharmaceutical Co., Ltd.
Conditions:
Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 everolim...
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...
Eligibility Criteria
Inclusion
- key
- 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 .
- 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.
- key
Exclusion
- 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);
- 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.
Key Trial Info
Start Date :
May 18 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 8 2025
Estimated Enrollment :
214 Patients enrolled
Trial Details
Trial ID
NCT05293964
Start Date
May 18 2022
End Date
September 8 2025
Last Update
November 29 2024
Active Locations (1)
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1
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China