Phase I Study of HSK42360 in Solid Tumors With BRAF V600 Mutation
NCT Number: NCT06536400
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Solid Tumors
Interventions: DRUG: HSK42360
Sponsor: Haisco Pharmaceutical Group Co., Ltd.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 316
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-06-25
Completion Date: 2027-07-07
Locations: Peking University First Hospital, Beijing, Beijing, 100034, China|Beijing TianTan Hospital,Capital Medical University, Beijing, Beijing, 100070, China|Beijing Cancer Hospital, Beijing, Beijing, 100142, China|The First Affiliated Hospital of Fujian Medical University, Fuzhou, Fujian, 350005, China|Sun Yat-Sen University Cancer Center, Guangzhou, Guangdong, 510145, China|Guangxi Medical University Cancer Hospital, Nanning, Guangxi, 530012, China|The Third People's Hospital of Zhengzhou, Zhengzhou, Henan, 450099, China|Hunan Cancer Hospital, Changsha, Hunan, 410000, China|Hunan Cancer Hospital, Changsha, Hunan, 410000, China|Nanjing Drum Tower Hospital, Nanjing, Jiangsu, 210000, China|Nanjing Drum Tower Hospital, Nanjing, Jiangsu, 210000, China|Fudan University Shanghai Cancer Center, Shanghai, Shanghai, 201321, China|Affiliated Hangzhou First People's Hospital, School of Medicine, Westlake University, Hangzhou, Zhejiang, 310006, China

Summary:
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.

Primary Outcome Measures: MTD, MTD determination: dose limiting toxicity (DLT) rate, Up to approximately 52 months|DLTs, Incidence of dose-limiting toxicities (DLTs) at Cycle 0 and Cycle1, Up to approximately 52 months|AEs, Rate and severity of adverse events of HSK42360 as monotherapy, Up to approximately 52 months|RP2D, RP2D determination: DLT, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary safety and anticancer activity data, Up to approximately 52 months|ECOG Performance Status Scale, Change of the grade as a part of HSK43260 safety data, Up to approximately 52 months|Karnofsky Performance Scale, KPS, Change of the grade as a part of HSK43260 safety data, Up to approximately 52 months
Secondary Outcome Measures: Overall response rate (ORR), ORR, defined as the proportion of patients who experience a best response of confirmed CR or PR according to RECIST 1.1/RANO, Up to approximately 52 months|Disease control rate (DCR), DCR, defined as the proportion of patients who experience a best response of CR, PR, or stable disease (SD) according to RECIST 1.1, Up to approximately 52 months|Duration of response (DOR), DOR, defined as the time from first documented response of complete response (CR) or partial response (PR) to the date of first documented progressive disease or death due to any cause, whichever occurs first, Up to approximately 52 months|Progression free survival (PFS), PFS, defined as the time frocease or death due to any cause, whichever occurs first, Up to approximately 52 months|Overall survival (OS), OS, defined as the time from the first dose of HSK42360 until the date of death due to any cause, Up to approximately 52 months|Area under the curve (AUC) of HSK42360, Circle 0 (single-dose circle, 3 days) and circle 1 (multiple-dose circle, 21days)|maximum plasma concentration (Cmax) of HSK42360, Circle 0 (single-dose circle, 3 days) and circle 1 (multiple-dose circle, 21days)|half-life (t1/2) of HSK42360, Circle 0 (single-dose circle, 3 days) and circle 1 (multiple-dose circle, 21days)|Tmax(Time to maximum plasma concentration) of HSK42360, Circle 0 (single-dose circle, 3 days) and circle 1 (multiple-dose circle, 21days)
Other Outcome Measures: circulating tumor DNA (ctDNA), Assess treatment-induced modulation of MAPK pathway biomarkers, Up to approximately 52 months|phosphorylate ERK (pERK), Assess the degradation of pERK protein, Up to approximately 52 months