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New treatment option for Advanced Solid Tumor
Official title Phase 1/2 Study of HS-10370 in Patients with Advanced Solid Tumors
ClinicalTrials.gov ID: NCT05367778
What this study is testing
What is HS-10370?
HS-10370 is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for advanced solid tumor.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- HS-10370 is an oral, highly selective, small molecular inhibitor of KRAS G12C. This study will evaluate the safety, tolerability, pharmacokinetics and clinical activity of HS-10370 in Chinese advanced solid tumor patients.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- people must meet all of the following to be eligible for participation in this study:
- Men or women greater than or equal to 18 years
- Locally advanced or metastatic cancer patients confirmed by histology or cytology, for which standard treatment is invalid, unavailable or intolerable
- Pathological, tumor tissue samples can be used to test KRAS G12C mutation by central laboratory for Phase 1b people.
- At least one measurable lesion in accordance with RECIST 1.1
You likely can't join if
- Treatment with any of the following:
- Previous or current treatment with KRAS G12C inhibitors
- Any cytotoxic chemotherapy, anticancer Chinese medicine and targeted small molecule inhibitors within 14 days of the first dose of HS-10370
- Any investigational agents and large molecule antibodies within 28 days of the first dose of HS-10370
- 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...
- Major surgery (including craniotomy, thoracotomy, or laparotomy, etc.) within 4 weeks of the first dose of HS-10370
See the full eligibility criteria
- people must meet all of the following to be eligible for participation in this study:
- Men or women greater than or equal to 18 years
- Locally advanced or metastatic cancer patients confirmed by histology or cytology, for which standard treatment is invalid, unavailable or intolerable
- Pathological, tumor tissue samples can be used to test KRAS G12C mutation by central laboratory for Phase 1b people.
- At least one measurable lesion in accordance with RECIST 1.1
- Eastern Cooperative Oncology Group (ECOG) performance status: 0\~1
- Estimated life expectancy \>12 weeks
- 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...
- Females must have the evidence of non-childbearing potential
- Signed and dated Informed Consent Form
- Treatment with any of the following:
- Previous or current treatment with KRAS G12C inhibitors
- Any cytotoxic chemotherapy, anticancer Chinese medicine and targeted small molecule inhibitors within 14 days of the first dose of HS-10370
- Any investigational agents and large molecule antibodies within 28 days of the first dose of HS-10370
- 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
- Major surgery (including craniotomy, thoracotomy, or laparotomy, etc.) within 4 weeks of the first dose of HS-10370
- Inadequate bone marrow reserve or serious organ dysfunction
- Uncontrolled pleural, ascites or pericardial effusion
- Known and untreated, or active central nervous system metastases
- Active autoimmune diseases or active infectious disease
- Refractory nausea, vomiting, or chronic gastrointestinal diseases, or inability to swallow oral medications
- 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
- The subject who is unlikely to comply with study procedures, restrictions, or requirements judged by the investigator
- The subject whose safety cannot be ensured or study assessments would be interfered judged by the investigator
- Pregnant women, breastfeeding women or woman who has a child-bearing plan during the study
- History of neuropathy or mental disorders, including epilepsy and dementia
The study team makes the final eligibility decision.
Where it's taking place
- Wuhan, Hubei, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Wuhan, Hubei, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.