Phase I Study to Evaluate SCR-6852 Alone or in Combination in ER+, HER2- Locally Advanced or Metastatic Breast Cancer

• Status: Not yet recruiting
• Trial end date: 2025-09-08
• Target enrollment: 0
• Participant gender: All

Summary

This study is a multi-center, open-label, Phase 1 clinical study to evaluate the safety, kinetics and anti-tumor efficacy of SCR-6852 and SCR-6852 in combination with palbociclib in subjects with estrogen receptor (ER) -positive, human epidermal growth factor receptor (HER-2) -negative locally advanced or metastatic breast cancer.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jiangsu Simcere Pharmaceutical Co., Ltd.
• Treatments: Palbociclib

Criteria

key Inclusion Criteria:

1. voluntary participation in clinical trials and signature of informed consent.

2. age ≥ 18 years, male or female.

3. Histologically or cytologically confirmed metastatic/locally advanced ER-positive, HER-2 negative breast cancer subjects.

4. previous treatment meets the criteria of the protocol defined.

5. ECOG score of 0 or 1 .

6. at least one measurable lesion that meets RECISTv1.1 criteria.

7. expected survival ≥ 12 weeks.

8. Adequate organ and bone marrow function.

9. Women of childbearing potential must have a negative serum pregnancy test within 7 days prior to the first dose.

key Exclusion Criteria:

1. Documented medical history or ongoing gastrointestinal disease or other malabsorption that may affect the absorption of oral study drug.

2. 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;

3. 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).

4. Major surgical surgery (except biopsy) or incomplete healing of the surgical incision 4 times before the first study drug treatment;

5. Known other malignant tumors within 2 years before enrollment (except treated basal cell carcinoma, scaly cell carcinoma and/or radical carcinoma in situ);

6. meningeal metastasis confirmed by MRI or cerebrospinal fluid cytology, increased intracranial pressure or unstable central nervous symptoms of brain metastasis (need to use any intracranial antihypertensive agents, glucocorticoids or anticonvulsant drugs within 2 weeks before the first dose);

7. 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;

8. known to interfere with the test requirements of mental illness or drug abuse disease.

9. History of human immunodeficiency virus HIV infection, or active bacterial or fungal infection requiring systemic treatment 14.

10. presence of active syphilis infection.

11. Subjects with known active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection with abnormal liver function.

12. History of clinically significant cardiovascular disease.

13. History of serious allergic reactions to the study drugs or excipients used in the protocol.

14. Women who are pregnant or lactating.

15. Prior use of SERD oral medications.

16. Subjects who use drugs or herbal supplements known to be moderate/strong inhibitors of CYP3A 2. Subjects who use drugs or herbal supplements known to be moderate/strong inducers of CYP3A 4 weeks before the first dose.

17. Other conditions that the investigator considers unsuitable for this study.