AzTrials
AzTrials

Solid Tumors (Phase 1)Phase 1NCT07561554

Phase I Study of HSK42360-Na in Solid Tumors With BRAF V600 Mutation

A Phase 1 study testing HSK42360-Na in people with Solid Tumors (Phase 1), run by Haisco Pharmaceutical Group Co., Ltd. at 2 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
Search all trials

Trial summary

This is a phase I, open-label, dose-escalation and expansion study to evaluate the safety, tolerability, PK and PD of HSK42360-Na when given orally in patients with active BRAF V600 mutation locally advanced or metastatic Solid Tumors. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Solid Tumors (Phase 1)
What is being tested?
HSK42360-Na
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
159 participants
Where
2 sitesChina
Study dates
6 Mar 2026to 2 Dec 2028
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 ≥ 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≥70.
  • 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 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-Na.
  • Patients will provide blood or tumor sample according to their own willingness.
Show all 10Show fewer
  • 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 after the last dose.

Who cannot join

  • 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-Na, whichever is shorter; Prior treatment with nitrosourea or mitomycin C within 6 weeks prior to the first dose of HSK42360-Na; Prior treatment with palliative radiotherapy or anti-tumor herbs within 2 weeks prior to the first dose of HSK42360-Na; Prior treatment with radiotherapy, electric field therapy, or other anti-tumor therapies within 4 weeks prior to the first dose of HSK42360-Na.
  • 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.
  • Any disease which would preclude drug absorption, metabolism or pharmacokinetics, e.g. active peptic ulcer or chronic gastroesophageal reflux disease.
Show all 21Show fewer
  • 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-Na.
  • Any thromboembolic events within 6 months prior to the first dose of HSK42360-Na; 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 interstitial fibrosis, Parkinson's disease, active bleeding, or systemic active infection.
  • 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-Na, 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-Na; Allogeneic transplantation, or stem-cell Transplant surgery within 6 months prior to the first dose of HSK42360-Na; Major surgery or significant traumatic injury occurring within 4 weeks prior to the first dose of HSK42360-Na.
  • 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-Na active constituent or ingredients.
  • Participate in other clinical trials within 4 weeks prior to the first dose of HSK42360-Na.
  • 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

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

Lin Shen contact

0086-10-88196561

doctorshenlin@sina.cn

China2 sites, 2 recruiting

  • Beijing TianTan Hospital,Capital Medical University

    Beijing, Beijing Municipality, 100070

    WenBin Li, 15301377998, neure55@126.com

    Recruiting

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality, 100142

    Lin Shen, 0086-10-88196561, doctorshenlin@sina.cn

    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, Pharmacokinetic and Pharmacodynamic of HSK42360-Na in Patients With BRAF V600 Mutation Locally Advanced or Metastatic Solid Tumors

This is a phase I, open-label, dose-escalation and expansion study to evaluate the safety, tolerability, PK and PD of HSK42360-Na when given orally in patients with active BRAF V600 mutation locally advanced or metastatic Solid Tumors.

Being tested
HSK42360-Na

What participants receive

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

  • HSK42360-NaDrug

    Oral administration

Study groups in NCT07561554
Study groupRoleWhat they receive
Phase Ia: HSK42360-Na as monotherapyExperimentalPhase 1a (Part A): dose escalation of HSK42360-Na as monotherapy at various dose levels
Receives: Drug: HSK42360-Na
Phase Ib: HSK42360-Na as monotherapyExperimentalPhase 1b: dose expansion for HSK40118 as monotherapy at a dose determined during Phase 1a
Receives: Drug: HSK42360-Na

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 Cycle 0 and Cycle1

    Measured: Up to approximately 52 months

  3. AEs

    Rate and severity of adverse events of HSK42360-Na as monotherapy

    Measured: Up to approximately 52 months

  4. RP2D

    The RP2D is determined based on multiple parameters

    Measured: Up to approximately 52 months

  5. ECOG Performance Status Scale

    Change of the grade as a part of HSK43260 safety data. Scores range from 0 to 5, with lower scores indicating better patient performance status.

    Measured: Up to approximately 52 months

  6. Karnofsky Performance Scale, KPS

    Change of the grade as a part of HSK43260 safety data. Scores range from 0 to 100, with higher scores indicating better patient performance status.

    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 RECIST 1.1/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, or stable disease (SD) according to RECIST 1.1

    Measured: Up to approximately 52 months

  3. 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

    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-Na until the date of death due to any cause

    Measured: Up to approximately 52 months

  6. Area under the curve (AUC) of HSK42360-Na

    Measured: Circle 0 (single-dose circle, 3 days) and circle 1 (multiple-dose circle, 21days)

  7. maximum plasma concentration (Cmax) of HSK42360-Na

    Measured: Circle 0 (single-dose circle, 3 days) and circle 1 (multiple-dose circle, 21days)

  8. half-life (t1/2) of HSK42360-Na

    Measured: Circle 0 (single-dose circle, 3 days) and circle 1 (multiple-dose circle, 21days)

  9. Tmax(Time to maximum plasma concentration) of HSK42360-Na

    Measured: Circle 0 (single-dose circle, 3 days) and circle 1 (multiple-dose circle, 21days)

Timeline

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

  1. First posted1 May 2026
  2. Study start6 Mar 2026
  3. Primary completion2 Dec 2028 (estimated)
  4. Study completion2 Dec 2028 (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
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
159 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07561554
Sponsor's protocol ID
HSK42360-Na-T1-101
Status last verified
Apr 2026
First submitted
23 Mar 2026
Last updated
1 May 2026
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-Na in people with Solid Tumors (Phase 1), run by Haisco Pharmaceutical Group Co., Ltd. at 2 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 21 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 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 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?

Contact Lin Shen (0086-10-88196561, doctorshenlin@sina.cn), or a site near the patient. 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 6 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 NCT07561554.

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 1 May 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in