Phase I Study of HSK42360 in Malignant Brain Tumors With BRAF V600 Mutation
ConditionMalignant Brain Tumors
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorHaisco Pharmaceutical Group Co., Ltd.
About this trial
This is a phase I, open-label, dose-escalation and expansion study to evaluate the safety, tolerability, PK of HSK42360 when given orally in pediatric patients with active BRAF V600 mutation recurrent malignant brain tumors.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥6 and <18 years.
Karnofsky/Lansky Performance Status >60.
Life expectancy ≥ 3 months.
Patients with recurrent malignant brain 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.
Disqualifiers
Patients with NF1 mutation.
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.
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.
Trial design
Design model
Single group
Treatments tested in this trial
HSK42360
DrugOral administration, QD/BID
Treatment groups
159 Participants
are divided into 2 treatment groupsGroup A: Phase Ia: HSK42360 as monotherapyExperimental treatment 1 intervention
Group B: Phase Ib: HSK42360 as monotherapyExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
MTD
MTD determination: dose limiting toxicity (DLT) rate
Time frame
Up to approximately 52 months2
DLTs
Incidence of dose-limiting toxicities (DLTs) at Cycle1
Time frame
Up to approximately 52 months3
AEs
Rate and severity of adverse events of HSK42360 as monotherapy
Time frame
Up to approximately 52 months4
RP2D
RP2D determination: DLT, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary safety and anticancer activity data
Time frame
Up to approximately 52 monthsSecondary outcomes
1
Overall response rate (ORR)
ORR, defined as the proportion of patients who experience a best response of confirmed CR or PR according to RANO
Time frame
Up to approximately 52 months2
Disease control rate (DCR)
DCR, defined as the proportion of patients who experience a best response of CR, PR, MR or stable disease (SD) according to RANO
Time frame
Up to approximately 52 months3
Duration of response (DOR)
DOR, defined as the time from first documented response of CR, PR or MR to the date of first documented progressive disease or death due to any cause, whichever occurs first
Time frame
Up to approximately 52 months4
Progression free survival (PFS)
PFS, defined as the time frocease or death due to any cause, whichever occurs first
Time frame
Up to approximately 52 monthsSponsors and contacts
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Source ClinicalTrials.gov