Overview

A Study of HS-10365 in Patients With Advanced or Metastatic RET Fusion-Positive Non-Small Cell Lung Cancer

Status:
Recruiting
Trial end date:
2028-08-31
Target enrollment:
0
Participant gender:
All
Summary
HS-10365 is a small molecular, oral potent, selective RET inhibitor. The purpose of this study is to investigate the efficacy and safety of HS-10365 in Chinese advanced RET fusion-positive non-small cell lung cancer patients without any systemic therapy.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Jiangsu Hansoh Pharmaceutical Co., Ltd.
Criteria
Inclusion Criteria:

1. Men or women aged more than or equal to (≥) 18 years.

2. Histologically or cytologically confirmed diagnosis of locally advanced or metastatic
NSCLC with RET fusion-positive, including recurrent or initial diagnosed Stage
IIIB-IIIC/IV NSCLC that is not suitable for radical surgery.

3. A RET gene fusion is required by using tumor tissue for central testing.

4. At least one measurable lesion in accordance with RECIST 1.1

5. Eastern Cooperative Oncology Group (ECOG) performance status: 0~1.

6. Estimated life expectancy >12 weeks.

7. Reproductive-age women agree to use adequate contraception and cannot breastfeed while
participating in this study and for a period of 6 months after the last dose.
Likewise, men also consent to use adequate contraceptive method within the same time
limit.

8. Females must have evidence of non-childbearing potential.

9. Signed and dated Informed Consent Form.

Exclusion Criteria:

1. Treatment with any of the following:

Additional validated oncogenic drivers in NSCLC if known. Previous or current
treatment with selective RET inhibitors or multi-kinase Inhibitor of RET.

Prior systemic therapy for metastatic disease. Treatment (including chemotherapy or
immunotherapy) in the adjuvant/neoadjuvant setting is permitted if it was completed at
least 6 months prior to relapse.

Local radiotherapy for palliation within 2 weeks of the first dose of study drug, or
patients received more than 30% of the bone marrow irradiation, or large-scale
radiotherapy within 4 weeks of the first dose.

Major surgery (including craniotomy, thoracotomy, or laparotomy, etc.) within 4 weeks
of the first dose of study drug.

2. Inadequate bone marrow reserve or serious organ dysfunction.

3. Uncontrolled pleural effusion or ascites or pericardial effusion.

4. Known and untreated, or active central nervous system metastases.

5. Active autoimmune diseases or active infectious disease

6. Refractory nausea, vomiting, or chronic gastrointestinal diseases, or inability to
swallow oral medications.

7. History of severe allergic reaction, hypersensitivity to any active or inactive
ingredient of HS-10365 or to drugs with a similar chemical structure or class to
HS-10365.

8. The subject who is unlikely to comply with study procedures, restrictions, or
requirements judged by the investigator.

9. The subject whose safety cannot be ensured or study assessments would be interfered
judged by the investigator.

10. Pregnant women, breastfeeding women or woman who has a child-bearing plan during the
study.

11. History of neuropathy or mental disorders, including epilepsy and dementia