Phase I Study to Evaluate SIM0270 Alone or in Combination in ER+, HER2- Locally Advanced or Metas… (NCT05293964) | Clinical Trial Compass
Active — Not RecruitingPhase 1
Phase I Study to Evaluate SIM0270 Alone or in Combination in ER+, HER2- Locally Advanced or Metastatic Breast Cancer
China214 participantsStarted 2022-05-18
Plain-language 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 advanced or metastatic breast cancer.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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.
Exclusion criteria
✕. 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).
What they're measuring
1
Maximum Tolerated Dose
Timeframe: At the end of Cycle 1 (each cycle is 28 days)
2
recommended phase 2 Dose
Timeframe: At the end of Cycle 1 (each cycle is 28 days)
3
Dose-Limiting Toxicities
Timeframe: At the end of Cycle 1 (each cycle is 28 days)
✕. 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.