SC10914 Monotherapy for the mCRPC With g/s BRCA Mutation

• Status: Not yet recruiting
• Trial end date: 2022-06-30
• Target enrollment: 0
• Participant gender: Male

Summary

This study is a multicenter, single arm phase I / II clinical study in mCRPC subjects who failed to receive docetaxel chemotherapy, abitolone acetate and / or enzalutamide (including its analogues) for the treatment of BRCA mutations in germ cells and / or somatic cells.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jiangxi Qingfeng Pharmaceutical Co. Ltd.

Criteria

Inclusion Criteria:

1. Signing informed consent voluntarily;

2. Prostate cancer confirmed by histology or cytology;

3. Metastatic lesions proved by imaging (CT / MRI / bone scan);

4. At least one measurable lesion in accordance with recist1.1;

5. deleterious or suspected deleterious germline and/or somatic BRCA-mutated (g/sBRCAm)

6. ECOG≤2；

7. The expected survival time was more than 3 months;

8. Serum testosterone levels ≤ 50 ng/dL (≤ 1.75 nmol/L) at screening.

9. Subjects without prior surgical castration must be currently taking and willing to continue luteinizing hormone-releasing hormone (LHRH) analog (agonist or antagonist) therapy throughout the duration of study treatment.

9.Subjects must have progressed on prior NHA (e.g. abiraterone acetate and/or enzalutamide) for the treatment of mCRPC. 10.Subjects must have progressed on prior chemotherapy with docetaxel for the treatment of mCRPC.

Exclusion Criteria:

1. Any previous treatment with PARP inhibitor

2. Concomitant use of known strong CYP3A inhibitors or moderate CYP3A inhibitors. The required washout period prior to starting olaparib is 2 weeks or 5 half-life.

3. Subjects with known brain metastases.

4. Major surgery within 2 weeks of starting study treatment and subjects must have recovered from any effects of any major surgery

5. Subjects unable to swallow orally administered medication and subjects with gastrointestinal disorders likely to interfere with Absorption, distribution, metabolism and excretion of the study

6. Immunocompromised subjects, e.g., subjects who are known to be serologically positive for human immunodeficiency virus (HIV)

7. Subjects with a known hypersensitivity to SC10914 or any of the excipients of the product

8. Subjects with known active hepatitis (i.e. Hepatitis B or C)

9. Subjects with not enough organ functional reserve at baseline, which met at least one of the following criteria：

1. ANC<1.5×109/L；

2. PLT<100×109/L；

3. Hb<100g/L；

4. TBIL>1.5×ULN；

5. ALT、AST>2.5×ULN unless liver metastases are present in which case they must be > 5×ULN；

6. Cr >1.5×ULN。

10. Subjects who have impaired cardiac function or clinically significant cardiac diseases, including any of the following:

1. Baseline QT interval corrected for heart rate (HR) using Fridericia's formula >500 msec or congenital long QT syndrome;

2. Left ventricular ejection fraction (LVEF) <50% assessed by echocardiogram;

3. Other clinically significant heart disease such as congestive heart failure NYHA Class IV and requiring heart transplant

11. Severe bone injury caused by tumor bone metastases as judged by the researchers, including severe bone pain due to poor control, pathological fracture of important parts or spinal cord compression occurred or expected to occur in the near future in the last 6 months.