Phase I Study of HSK42360 in Solid Tumors With BRAF V600 Mutation
NCT ID: NCT06536400
Last Updated: 2024-08-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
316 participants
INTERVENTIONAL
2024-06-25
2027-07-07
Brief Summary
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Detailed Description
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Phase Ia will contain two part: Dose Escalation Part (Part A) and Extension Part (Part B). Part A based on the "3+3" design for dose escalation and safety evaluation requirements. Patient cohorts at selected doses may be extended to further investigate the tolerability, PK and PD of HSK42360. The number of patients to be enrolled will be up to 10 subjects in each Part B cohort. Approximately 30-70 subjects will be enrolled in Phase Ia.
Phase Ib no less than 10-50 subjects will be enrolled in each expansion cohort.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Phase Ia (Part A): HSK42360 as monotherapy
Phase 1a (Part A): dose escalation of HSK42360 as monotherapy at various dose levels
HSK42360
Oral administration, QD
Phase Ia (Part B): HSK42360 as monotherapy
Phase 1a (Part B): dose extention of HSK42360 as monotherapy at certain dose levels
HSK42360
Oral administration, QD
Phase Ib: HSK42360 as monotherapy
Phase 1b: dose expansion for HSK40118 as monotherapy at a dose determined during Phase 1a (Part B) in patients with BRAF V600 mutation locally advanced or metastatic solid tumors
HSK42360
Oral administration, QD
Interventions
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HSK42360
Oral administration, QD
Eligibility Criteria
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Inclusion Criteria
2. ECOG performance status 0-1, or KPS (Karnofsky Performance Status) Score\>60.
3. Life expectancy ≥ 3 months.
4. 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 previously received BRAF and/or MEK inhibitor therapy are allowed to be included in this study.
5. Positive BRAF V600 mutation result confirmed prior to the administration of HSK42360.
6. Patients will provide blood or tumor sample according to their own willingness.
7. Measurable or non-measurable disease by RECIST 1.1 or RANO criteria.
8. 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.
9. Adequate hematologic, hepatic, and renal function.
10. 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 after the last dose.
Exclusion Criteria
2. Uncontrollable pleural effusion, ascites, or pericardial effusion per protocol.
3. 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 C within 6 weeks prior to the first dose of HSK42360; Prior treatment with palliative radiotherapy or anti-tumor herbs within 2 weeks prior to the first dose of HSK42360; Prior treatment with radiotherapy, electric field therapy, or other anti-tumor therapies within 4 weeks prior to the first dose of HSK42360.
4. 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 other toxicity considering no safety risks by investigator.
5. Any disease which would preclude drug absorption, metabolism or pharmacokinetics, e.g. active peptic ulcer or chronic gastroesophageal reflux disease.
6. 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 infarction, unstable angina, or class III/IV cardiac failure by the NYHA that occurred within 6 months prior to the first dose of HSK42360.
7. Any thromboembolic events within 6 months prior to the first dose of HSK42360; any familial or acquired thrombophilia.
8. Uncontrolled hypertension (systolic pressure≥160mmHg, or diastolic pressure≥100mmHg), diabetes (fasting blood-glucose≥10mmol/L), seizures, chronic obstructive pulmonary disease (COPD), interstitial pneumonia, pulmonary interstitial fibrosis, Parkinson's disease, active bleeding, or systemic active infection.
9. Any unstable systemic disease, e.g. severe metabolic disease: liver cirrhosis, renal failure, or uremia.
10. 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 is shorter.
11. Patient with cognitive dysfunction, or history of mental illness, other uncontrolled comorbidities, alcohol dependence, hormone dependence or drug abuse.
12. 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 significant traumatic injury occurring within 4 weeks prior to the first dose of HSK42360.
13. Patient with a history of immunodeficiency, including HIV positive, or other acquired/congenital immunodeficiency diseases.
14. Any disease of the eyes \> CTCAE v5.0 Grade 1.
15. Patient with active hepatitis B or hepatitis C.
16. Patient with active syphilis infection.
17. Allergic to any HSK42360 active constituent or ingredients.
18. Participate in other clinical trials within 4 weeks prior to the first dose of HSK42360.
19. Positive pregnancy test, or breastfeeding.
20. 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.
18 Years
ALL
No
Sponsors
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Haisco Pharmaceutical Group Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Peking University First Hospital
Beijing, Beijing Municipality, China
Beijing TianTan Hospital,Capital Medical University
Beijing, Beijing Municipality, China
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, China
Sun Yat-Sen University Cancer Center
Guangzhou, Guangdong, China
Guangxi Medical University Cancer Hospital
Nanning, Guangxi, China
The Third People's Hospital of Zhengzhou
Zhengzhou, Henan, China
Hunan Cancer Hospital
Changsha, Hunan, China
Hunan Cancer Hospital
Changsha, Hunan, China
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, China
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, China
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
Affiliated Hangzhou First People's Hospital, School of Medicine, Westlake University
Hangzhou, Zhejiang, China
Countries
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Facility Contacts
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Other Identifiers
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HSK42360-101
Identifier Type: -
Identifier Source: org_study_id
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