Testing HS-10370 for advanced solid tumors

A Phase 1/2, Open-label, Multicenter Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of HS-10370 Monotherapy in Patients with Advanced Solid Tumors

This study is testing a new oral medication called HS-10370 to see if it can help people with advanced solid tumors, especially those with a specific lung cancer mutation.

Quick facts

• Phase: PHASE1; PHASE2
• Study type: Interventional
• Enrollment: 176 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd. (industry)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Wuhan, Hubei)
• Trial ID: NCT05367778 on ClinicalTrials.gov

What this trial studies

This phase 1/2 study evaluates HS-10370, an oral small molecular inhibitor targeting the KRAS G12C mutation, in patients with advanced solid tumors. The study is divided into two parts: the first part focuses on dose escalation and safety assessment, while the second part aims to determine the efficacy of HS-10370 specifically in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring the KRAS G12C mutation. The study will be conducted in multiple centers in China.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with locally advanced or metastatic solid tumors for which standard treatments are not suitable.

Not a fit: Patients with tumors that do not have the KRAS G12C mutation or those who are not eligible for the study criteria may not benefit from this treatment.

Why it matters

Potential benefit: If successful, this treatment could provide a new targeted therapy option for patients with advanced solid tumors, particularly those with the KRAS G12C mutation.

How similar studies have performed: Other studies targeting KRAS mutations have shown promise, indicating potential for success with this novel approach.

Eligibility criteria

Inclusion Criteria:

Subjects must meet all of the following inclusion criteria to be eligible for participation in this study:

1. Men or women greater than or equal to 18 years
2. Locally advanced or metastatic cancer patients confirmed by histology or cytology, for which standard treatment is invalid, unavailable or intolerable
3. Pathological, tumor tissue samples can be used to test KRAS G12C mutation by central laboratory for Phase 1b 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:

   1. Previous or current treatment with KRAS G12C inhibitors
   2. Any cytotoxic chemotherapy, anticancer Chinese medicine and targeted small molecule inhibitors within 14 days of the first dose of HS-10370
   3. Any investigational agents and large molecule antibodies within 28 days of the first dose of HS-10370
   4. Local radiotherapy for palliation within 2 weeks of the first dose of HS-10370, or patients received more than 30% of the bone marrow irradiation, or large-scale radiotherapy within 4 weeks of the first dose of HS-10370
   5. Major surgery (including craniotomy, thoracotomy, or laparotomy, etc.) within 4 weeks of the first dose of HS-10370
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-10370 or to drugs with a similar chemical structure or drugs belonging to the same category of HS-10370
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

Wuhan, Hubei

• Union Hospital Tong Ji Medical College, HuaZhong University of Science and Technology — Wuhan, Hubei, China (RECRUITING)

Study contacts

• Principal investigator: Xiaorong Dong, PhD — Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
• Study coordinator: Xiaorong Dong, PhD

Conditions: Advanced Solid Tumor, KRAS G12C mutation, HS-10370