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Malignant Brain TumorsPhase 1NCT07158710

Phase I Study of HSK42360 in Malignant Brain Tumors With BRAF V600 Mutation

A Phase 1 study testing HSK42360 in people with Malignant Brain Tumors, run by Haisco Pharmaceutical Group Co., Ltd. at 6 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Malignant Brain Tumors
What is being tested?
HSK42360
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
159 participants
Where
6 sitesChina
Study dates
15 Aug 2025to 3 Dec 2029
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
  • Positive BRAF V600 mutation result confirmed prior to the administration of HSK42360.
  • Patients will provide blood or tumor sample according to their own willingness.
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  • Measurable disease by RANO criteria.
  • Patients with inactive CNS lesions, or patients treated with ≤5mg/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 after the last dose.

Who cannot join

  • 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.
  • 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.
  • 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.
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  • Any disease which would preclude drug absorption, metabolism or pharmacokinetics, eg. active peptic ulcer or chronic gastroesophageal reflux disease.
  • Patient who have clinically significant or uncontrolled cardiac disease, include: QTc interval ≥ 450 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.
  • Any thromboembolic events within 6 months prior to the first dose of HSK42360; any familial or aquired thrombophilia.
  • Any unstable systemic disease, eg. 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 is shorter.
  • 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 significant traumatic injury occurring within 4 weeks prior to the first dose of HSK42360.
  • Patient with a history of immunodeficiency, including HIV positive, or other acquired/congenital immunodeficiency diseases.
  • Patient with severe retinal abnormalities and uveitis.
  • Patient with active hepatitis B or hepatitis C.
  • 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.

Trial locations and contacts

6 sites in 1 country. Contact the study team or a site near you to ask about taking part.

6 sites in 1 country

China6 sites, 6 recruiting

  • Xuanwu Hospital Capital Medical University

    Beijing, Beijing Municipality, 100021

    Cuibai Wei, 13910076457, xwgcpht@xwh.ccmu.edu.cn

    Recruiting

  • Department of Neuro-oncology, Cancer Center, Beijing Tiantan Hospital, Capital Medical University,Beijing, China

    Beijing, Beijing Municipality, 100070

    WenBin Li, 15301377998, liwenbin@ccmu.edu.cn

    Recruiting

  • The Third Bethune Hospital of Jilin University

    Changchun, Jilin, 130000

    Yufei Gao, 13331686535, 416566173@qq.com

    Recruiting

  • The first affiliated hospital of fujian medical university

    Fuzhou, Fujian, 350200

    Dezhi Kang, 15759413951, kdz99988@sina.com

    Recruiting

  • Zhujiang Hospital of Southern Medical University

    Guangzhou, Guangdong, 510280

    Hongbo Guo, 020-62783372, zjyygcp@163.com

    Recruiting

  • Fudan University Affiliated Huashan Hospital

    Shanghai, Shanghai Municipality, 200000

    Tianming Qiu, 13501665370, Tianming2100@126.com

    Recruiting

Other trials in China

About this study

Official title: A Phase I, Open-label, Dose-escalation and Expansion Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of HSK42360 in Pediatric Patients With BRAF V600-Mutant Malignant Brain Tumors

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.

Being tested
HSK42360

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HSK42360Drug

    Oral administration, QD/BID

Study groups in NCT07158710
Study groupRoleWhat they receive
Phase Ia: HSK42360 as monotherapyExperimentalPhase 1a: dose escalation of HSK42360 as monotherapy at various dose levels
Receives: Drug: HSK42360
Phase Ib: HSK42360 as monotherapyExperimentalPhase 1b: dose expansion for HSK40118 as monotherapy at a dose determined during Phase 1a in patients with BRAF V600 recurrent mutation malignant brain tumors
Receives: Drug: HSK42360

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. MTD

    MTD determination: dose limiting toxicity (DLT) rate

    Measured: Up to approximately 52 months

  2. DLTs

    Incidence of dose-limiting toxicities (DLTs) at Cycle1

    Measured: Up to approximately 52 months

  3. AEs

    Rate and severity of adverse events of HSK42360 as monotherapy

    Measured: Up to approximately 52 months

  4. RP2D

    RP2D determination: DLT, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary safety and anticancer activity data

    Measured: Up to approximately 52 months

  5. Karnofsky/Lansky Performance Scale

    Change of the grade as a part of HSK43260 safety data

    Measured: Up to approximately 52 months

Secondary outcomes (9)

  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

    Measured: Up to approximately 52 months

  2. 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

    Measured: Up to approximately 52 months

  3. 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

    Measured: Up to approximately 52 months

  4. Progression free survival (PFS)

    PFS, defined as the time frocease or death due to any cause, whichever occurs first

    Measured: Up to approximately 52 months

  5. Overall survival (OS)

    OS, defined as the time from the first dose of HSK42360 until the date of death due to any cause

    Measured: Up to approximately 52 months

  6. Area under the curve (AUC)

    Measured: Circle 1 (28days)

  7. maximum plasma concentration (Cmax)

    Measured: Circle 1 (28days)

  8. half-life (t1/2)

    Measured: Circle 1 (28days)

  9. Tmax(Time to maximum plasma concentration)

    Measured: Circle 1 (28days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Sep 2025
  2. Study start15 Aug 2025
  3. Primary completion23 May 2029 (estimated)
  4. Study completion3 Dec 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
159 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07158710
Sponsor's protocol ID
HSK42360-103
Status last verified
Jul 2025
First submitted
6 Aug 2025
Last updated
8 Sep 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing HSK42360 in people with Malignant Brain Tumors, run by Haisco Pharmaceutical Group Co., Ltd. at 6 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 8 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

MTD (time frame: Up to approximately 52 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07158710.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2025.

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