Solid TumorsPhase 1NCT06536400
Phase I Study of HSK42360 in Solid Tumors With BRAF V600 Mutation
A Phase 1 study testing HSK42360 in people with Solid Tumors, run by Haisco Pharmaceutical Group Co., Ltd. at 13 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid 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
- 316 participants
- Where
- 13 sitesChina
- Study dates
- 25 Jun 2024to 7 Jul 2027
- 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>60.
- 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.
- 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, 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.
- 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.
- Any thromboembolic events within 6 months prior to the first dose of HSK42360; 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, 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.
- 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 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
13 sites in 1 country. Contact the study team or a site near you to ask about taking part.
13 sites in 1 country
China13 sites, 13 recruiting
- Recruiting
Peking University First Hospital
Beijing, Beijing Municipality, 100034
ShiKai Wu, 15810037307, Skywu4923@sina.com
- 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
Hunan Cancer Hospital
Changsha, Hunan, 410000
ZhengWen He, 13307311232, hezhengwen@hnca.org.cn
- Recruiting
Hunan Cancer Hospital
Changsha, Hunan, 410000
XianAn Li, 18874933879, lixianan2001@163.com
YongChang Zhang, 13873123436, zhangyongchang@hnca.org.cn
- Recruiting
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, 350005
DeZhi Kang, 15759413951, kdz99988@sina.com
- Recruiting
Sun Yat-Sen University Cancer Center
Guangzhou, Guangdong, 510145
XiaoShi Zhang, 15915733209, zhangxsh@sysucc.org.cn
- Recruiting
Affiliated Hangzhou First People's Hospital, School of Medicine, Westlake University
Hangzhou, Zhejiang, 310006
Ying Wang, 18367124548, nancywangying@163.com
Bing Xia, 18857110928, bingxia_hzch@163.com
- Recruiting
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, 210000
ZhengYun Zou, 13815891858, zouzhengyun001@163.com
Juan Li, 15951989771, Juanli2003@163.com
- Recruiting
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, 210000
RuTian Li, 13813863961, li_rutian@163.com
- Recruiting
Guangxi Medical University Cancer Hospital
Nanning, Guangxi, 530012
ZhenChao Yuan, 18677102309, yzhenchao11@163.com
Wei Jiang, 13557710254, 775022385@qq.com
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 201321
Jian Zhang, 18017312991, syner2000@163.com
Yu Xu, 18017312784, xuyudaniel@hotmail.com
- Recruiting
The Third People's Hospital of Zhengzhou
Zhengzhou, Henan, 450099
WeiZhen Zhang, 13937130192, zwzgcp@163.com
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 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 when given orally in patients with active BRAF V600 mutation locally advanced or metastatic Solid Tumors.
Read the detailed description
The study will contain two phases: Phase Ia is dose escalation phase and Phase Ib is dose expansion phase.
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
- Solid 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
| Study group | Role | What they receive |
|---|---|---|
| Phase Ia (Part A): HSK42360 as monotherapy | Experimental | Phase 1a (Part A): dose escalation of HSK42360 as monotherapy at various dose levels Receives: Drug: HSK42360 |
| Phase Ia (Part B): HSK42360 as monotherapy | Experimental | Phase 1a (Part B): dose extention of HSK42360 as monotherapy at certain dose levels Receives: Drug: HSK42360 |
| Phase Ib: HSK42360 as monotherapy | Experimental | 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 Receives: Drug: HSK42360 |
What is being measured
The primary outcome is the main question the study is designed to answer.
MTD
MTD determination: dose limiting toxicity (DLT) rate
Measured: Up to approximately 52 months
DLTs
Incidence of dose-limiting toxicities (DLTs) at Cycle 0 and Cycle1
Measured: Up to approximately 52 months
AEs
Rate and severity of adverse events of HSK42360 as monotherapy
Measured: Up to approximately 52 months
RP2D
RP2D determination: DLT, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary safety and anticancer activity data
Measured: Up to approximately 52 months
ECOG Performance Status Scale
Change of the grade as a part of HSK43260 safety data
Measured: Up to approximately 52 months
Karnofsky Performance Scale, KPS
Change of the grade as a part of HSK43260 safety data
Measured: Up to approximately 52 months
Secondary outcomes (9)
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
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
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
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
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
Area under the curve (AUC) of HSK42360
Measured: Circle 0 (single-dose circle, 3 days) and circle 1 (multiple-dose circle, 21days)
maximum plasma concentration (Cmax) of HSK42360
Measured: Circle 0 (single-dose circle, 3 days) and circle 1 (multiple-dose circle, 21days)
half-life (t1/2) of HSK42360
Measured: Circle 0 (single-dose circle, 3 days) and circle 1 (multiple-dose circle, 21days)
Tmax(Time to maximum plasma concentration) of HSK42360
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.
- First posted5 Aug 2024
- Study start25 Jun 2024
- Primary completion30 Aug 2026 (estimated)
- Study completion7 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorsStudies of the same condition, open and under way.
- More trials run by Haisco Pharmaceutical Group Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 316 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Haisco Pharmaceutical Group Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06536400
- Sponsor's protocol ID
- HSK42360-101
- Status last verified
- Aug 2024
- First submitted
- 24 Jul 2024
- Last updated
- 5 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Open-label, Dose-escalation and Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic of HSK42360 in Patients With BRAF V600 Mutation Locally Advanced or Metastatic Solid Tumors
- ClinicalTrials.gov ID
- NCT06536400
- Acronym / sponsor ID
- HSK42360-101
- Conditions
- Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 316 participants (estimated)
- Lead sponsor
- Haisco Pharmaceutical Group Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 25 Jun 2024 (actual)
- Primary completion
- 30 Aug 2026 (estimated)
- Study completion
- 7 Jul 2027 (estimated)
- First posted
- 5 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The study will contain two phases: Phase Ia is dose escalation phase and Phase Ib is dose expansion phase.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Phase Ia (Part A): HSK42360 as monotherapy | Experimental | Drug: HSK42360Phase 1a (Part A): dose escalation of HSK42360 as monotherapy at various dose levels |
| Phase Ia (Part B): HSK42360 as monotherapy | Experimental | Drug: HSK42360Phase 1a (Part B): dose extention of HSK42360 as monotherapy at certain dose levels |
| Phase Ib: HSK42360 as monotherapy | Experimental | Drug: HSK42360Phase 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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>60.
- 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.
Key exclusion criteria (21 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HSK42360Oral administration, QD | Drug | Phase Ia (Part A): HSK42360 as monotherapy, Phase Ia (Part B): HSK42360 as monotherapy, Phase Ib: HSK42360 as monotherapy |
Primary outcome
MTD
Time frame: Up to approximately 52 months
MTD determination: dose limiting toxicity (DLT) rate
DLTs
Time frame: Up to approximately 52 months
Incidence of dose-limiting toxicities (DLTs) at Cycle 0 and Cycle1
AEs
Time frame: Up to approximately 52 months
Rate and severity of adverse events of HSK42360 as monotherapy
RP2D
Time frame: Up to approximately 52 months
RP2D determination: DLT, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary safety and anticancer activity data
ECOG Performance Status Scale
Time frame: Up to approximately 52 months
Change of the grade as a part of HSK43260 safety data
Karnofsky Performance Scale, KPS
Time frame: Up to approximately 52 months
Change of the grade as a part of HSK43260 safety data
9 secondary outcomes
Overall response rate (ORR)
Time frame: Up to approximately 52 months
Disease control rate (DCR)
Time frame: Up to approximately 52 months
Duration of response (DOR)
Time frame: Up to approximately 52 months
Progression free survival (PFS)
Time frame: Up to approximately 52 months
Overall survival (OS)
Time frame: Up to approximately 52 months
Area under the curve (AUC) of HSK42360
Time frame: Circle 0 (single-dose circle, 3 days) and circle 1 (multiple-dose circle, 21days)
maximum plasma concentration (Cmax) of HSK42360
Time frame: Circle 0 (single-dose circle, 3 days) and circle 1 (multiple-dose circle, 21days)
half-life (t1/2) of HSK42360
Time frame: Circle 0 (single-dose circle, 3 days) and circle 1 (multiple-dose circle, 21days)
Tmax(Time to maximum plasma concentration) of HSK42360
Time frame: Circle 0 (single-dose circle, 3 days) and circle 1 (multiple-dose circle, 21days)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2024.
Related trials for Solid Tumors
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
Active, not recruitingPhase 3
A Safety and Efficacy Extension Study of Pertuzumab in Patients With Solid Tumors Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Clinical Trial
Solid Tumors
RecruitingPhase 1
IL-12 Genetically Engineered Myeloid Cells in Participants With Relapsed, Refractory Solid Tumors
Relapsed Solid Tumor Malignancies, Refractory Solid Tumor Malignancies
RecruitingObservational study
Immune Checkpoint Inhibitor Toxicity Risk Prediction in Solid Tumors
Malignant Solid Neoplasm
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HSK42360 in people with Solid Tumors, run by Haisco Pharmaceutical Group Co., Ltd. at 13 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 5 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 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 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?
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 5 Aug 2024; AzTrials last refreshed its copy on 6 Nov 2026.