Testing HS-10375 for advanced lung cancer

A Phase 1/2, Open-label, Multicenter Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of HS-10375 Monotherapy in Patients with Advanced or Metastatic Non-Small-Cell Lung Cancer(NSCLC)

This study is testing a new oral medication called HS-10375 to see if it can help people with advanced lung cancer who haven't had success with other treatments.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 354 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd. (Industry-sponsored)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT05435248 on ClinicalTrials.gov

What this trial studies

This study evaluates HS-10375, an oral small molecular inhibitor targeting the EGFR C797S mutation, in patients with advanced or metastatic non-small-cell lung cancer (NSCLC). It aims to assess the safety, tolerability, pharmacokinetics, and clinical activity of the drug in a population where standard treatments are ineffective or unavailable. The study will involve patients from China who meet specific eligibility criteria, including having measurable lesions and a certain performance status.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with advanced or metastatic NSCLC and confirmed EGFR C797S mutation.

Not a fit: Patients who have not been diagnosed with the EGFR C797S mutation or those for whom standard treatments are still effective may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced or metastatic NSCLC who have the EGFR C797S mutation.

How similar studies have performed: While this approach is novel in targeting the EGFR C797S mutation specifically, similar studies targeting other mutations in NSCLC have shown promise.

Eligibility criteria

Inclusion Criteria:

1. Men or women greater than or equal to 18 years.
2. Locally advanced or metastatic NSCLC patients confirmed by histology or cytology, for which standard treatment is invalid, unavailable or intolerable .
3. Pathological, NSCLC tissue samples can be used to test EGFR C797S mutation by central laboratory for Phase 1b and Phase II subjects.
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 the evidence of non-childbearing potential.
9. Signed and dated Informed Consent Form.

Exclusion Criteria:

1. Treatment with any of the following:

   * Previous or current treatment with EGFR C797S inhibitors.
   * Any cytotoxic chemotherapy, anticancer Chinese medicine and targeted small molecule inhibitors within 14 days of the first dose of HS-10375.
   * Any investigational agents and large molecule antibodies within 28 days of the first dose of HS-10375.
   * Local radiotherapy for palliation within 2 weeks of the first dose of HS-10375, or patients received more than 30% of the bone marrow irradiation, or large-scale radiotherapy within 4 weeks of the first dose of HS-10375.
   * Major surgery (including craniotomy, thoracotomy, or laparotomy, etc.) within 4 weeks of the first dose of HS-10375.
2. Inadequate bone marrow reserve or serious organ dysfunction.
3. Uncontrolled pleural, 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 hypersensitivity to any active or inactive ingredient of HS-10375 or to drugs with a similar chemical structure or drugs belonging to the same category of HS-10375.
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.

Where this trial is running

Guangzhou, Guangdong

• Sun Yat-sen University Cancer Center — Guangzhou, Guangdong, China (Recruiting)

Study contacts

• Study coordinator: Li Zhang, Master

Conditions Advanced or Metastatic NSCLC; Advanced or metastatic NSCLC; EGFR C797S mutation; HS-10375