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New treatment option for Solid Tumors
Official title Phase I Study of HSK42360 in Solid Tumors With BRAF V600 Mutation
ClinicalTrials.gov ID: NCT06536400
What this study is testing
What is HSK42360?
HSK42360 is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for solid tumors.
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
- This is a phase I, open-label, dose-escalation and expansion study to evaluate the safety, tolerability, PK and PD of HSK42360 when given orally in patients with active BRAF V600 mutation locally advanced or metastatic Solid Tumors.
- Phase 1: an early, usually small safety study
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
- Age ≥ 18 years，Male and female patients, at time of signing informed consent form (ICF).
- ECOG performance status 0-1, or KPS (Karnofsky Performance Status) Score\>60.
- Life expectancy ≥ 3 months.
- Patients with locally advanced or metastatic solid tumors confirmed by histology or cytology, who have failed standard treatment (disease progression...
- Positive BRAF V600 mutation result confirmed prior to the administration of HSK42360.
You likely can't join if
- malignant tumor within 2 years, with the exception of cutaneous squamous cell carcinoma, cervical carcinoma in situ, papillary thyroid carcinoma, or...
- Uncontrollable pleural effusion, ascites, or pericardial effusion per protocol.
- Treatment with any of the following: Prior treatment with anti-tumor drug within 4 weeks or approximately 5 × t1/2 prior to the first dose of...
- Any unresolved toxicities from prior therapy greater than Common Terminology Criteria for Adverse Events (CTCAE) grade 1 at the time of starting...
- Any disease which would preclude drug absorption, metabolism or pharmacokinetics, e.g. active peptic ulcer or chronic gastroesophageal reflux disease.
- Patients who have clinically significant or uncontrolled cardiac disease, include: QTc interval ≥ 450(male)/470(female) msec; any clinically...
See the full eligibility criteria
- Age ≥ 18 years，Male and female patients, at time of signing informed consent form (ICF).
- ECOG performance status 0-1, or KPS (Karnofsky Performance Status) Score\>60.
- Life expectancy ≥ 3 months.
- Patients with locally advanced or metastatic solid tumors confirmed by histology or cytology, who have failed standard treatment (disease progression after treatment or intolerable treatment); patients who have...
- Positive BRAF V600 mutation result confirmed prior to the administration of HSK42360.
- Patients will provide blood or tumor sample according to their own willingness.
- Measurable or non-measurable disease by RECIST 1.1 or RANO criteria.
- Brain metastasis patients with inactive CNS lesions; Original intracranial tumor patient with inactive CNS lesions, or patients treated with ≤4mg/day corticosteroid and without convulsion for ≥2 weeks.
- Adequate hematologic, hepatic, and renal function.
- Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days...
- malignant tumor within 2 years, with the exception of cutaneous squamous cell carcinoma, cervical carcinoma in situ, papillary thyroid carcinoma, or other tumors with low malignancy.
- Uncontrollable pleural effusion, ascites, or pericardial effusion per protocol.
- Treatment with any of the following: Prior treatment with anti-tumor drug within 4 weeks or approximately 5 × t1/2 prior to the first dose of HSK42360, whichever is shorter; Prior treatment with nitrosourea or mitomycin...
- Any unresolved toxicities from prior therapy greater than Common Terminology Criteria for Adverse Events (CTCAE) grade 1 at the time of starting study treatment, with the exception of alopecia, dermal toxicity, and...
- Any disease which would preclude drug absorption, metabolism or pharmacokinetics, e.g. active peptic ulcer or chronic gastroesophageal reflux disease.
- Patients who have clinically significant or uncontrolled cardiac disease, include: QTc interval ≥ 450(male)/470(female) msec; any clinically significant arrhythmia; left ventricular ejection fraction \< 50%; myocardial...
- Any thromboembolic events within 6 months prior to the first dose of HSK42360; any familial or acquired thrombophilia.
- Uncontrolled hypertension (systolic pressure≥160mmHg, or diastolic pressure≥100mmHg), diabetes (fasting blood-glucose≥10mmol/L), seizures, chronic obstructive pulmonary disease (COPD), interstitial pneumonia, pulmonary...
- Any unstable systemic disease, e.g. severe metabolic disease: liver cirrhosis, renal failure, or uremia.
- Treatment with inhibitors/inducers for CYP3A4, or substrates of CYP3A4, CYP2C9, CYP2C8, OATP1B1, OATP1B3, OAT1, OAT3, P-gp or BCRP within 14 days or approximately 5 × t1/2 prior to the first dose of HSK42360, whichever...
- Patient with cognitive dysfunction, or history of mental illness, other uncontrolled comorbidities, alcohol dependence, hormone dependence or drug abuse.
- Autologous transplantation surgery within 3 months prior to the first dose of HSK42360; Allogeneic transplantation, or stem-cell Transplant surgery within 6 months prior to the first dose of HSK42360; Major surgery or...
- Patient with a history of immunodeficiency, including HIV positive, or other acquired/congenital immunodeficiency diseases.
- Any disease of the eyes \> CTCAE v5.0 Grade 1.
- Patient with active hepatitis B or hepatitis C.
- Patient with active syphilis infection.
- Allergic to any HSK42360 active constituent or ingredients.
- Participate in other clinical trials within 4 weeks prior to the first dose of HSK42360.
- Positive pregnancy test, or breastfeeding.
- Any other circumstances that would, in the investigator's judgment, prevent the subject's participation in the clinical study due to safety concerns or compliance with clinical study procedures.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
- Fuzhou, Fujian, China
- Guangzhou, Guangdong, China
- Nanning, Guangxi, China
- Zhengzhou, Henan, China
- Changsha, Hunan, China
- Nanjing, Jiangsu, China
- Shanghai, Shanghai Municipality, China
- Hangzhou, Zhejiang, 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 Beijing, Beijing Municipality, China; Fuzhou, Fujian, China; Guangzhou, Guangdong, China; Nanning, Guangxi, China; Zhengzhou, Henan, China; Changsha, Hunan, China and 3 more location(s). 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.