Advanced Malignant TumorPhase 1NCT05144061
A First-in-human Study of HRS2398 Tablets in Subjects With Advanced Malignant Tumors
A Phase 1 study testing HRS2398 Tablets in people with Advanced Malignant Tumor, run by Shanghai Hengrui Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
The study is being conducted to determine the dose limited toxicity(DLT) and maximum tolerated dose(MTD) and recommended Phase 2 dose(RP2D) of HRS2398 in subjects with advanced malignant tumor ; The second objectives is to evaluate safety and preliminary efficacy and PK profile of HRS2398 in subjects with advanced… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Advanced Malignant Tumor
- What is being tested?
- HRS2398 Tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteChina
- Study dates
- 20 Dec 2021to 21 Feb 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects are able to give voluntary informed consent, understand the study and are willing to follow and complete all the test procedures.
- subjects ≥18 years and ≤70 years.
- Patients with Histologically or cytologically confirmed advanced Malignant tumors who had failed standard treatment or had not been treated with standard therapy.
- ECOG ≤1.
- Subjects with life expectancy of ≥ 3 months.
- At least one measurable lesion ( RECIST version 1.1).
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- Subjects must have adequate organ function (whole blood or component transfusion or BFGF within 2 weeks before 1st dose of study drug is prohibited):
- Absolute neutrophil count (ANC) ≥1.5 x10^9/L;
- Platelet count ≥ 100 x 10^9/L;
- Hemoglobin ≥ 90 g / L;
- Total bilirubin (TBil) ≤1.5 x ULN;
- Liver function tests alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3 x ULN, for patients with known liver cancer or liver metastases, AST and ALT ≤ 5 x ULN;
- Gr ≤ 1.5x ULN or an estimated glomerular filtration rate (eGFR) > 50 mL/min;
- INR ≤1.5 x ULN and APTT ≤ 1.5 x ULN;
- LVEF≥50%，QTc Male: <450ms; Female: <470ms.
- Subjects (males and females) of childbearing potential should be willing to use reliable contraception methods that are deemed effective by the investigator from visit 1 through 180 days following the last dose of study drug.
- Archived wax lump tumor tissue samples or biopsy and blood sample collection during screening period.
- As judged by the investigator, can follow protocol.
Who cannot join
- Untreated and/or uncontrolled brain metastases.
- Patients with clinical symptoms of cancer ascites, pleural effusion, who need to drainage, or who have undergone ascites drainage within 2 weeks prior to the first administration.
- Failure to recover from adverse events from the most recent anti-tumor treatment to CTCAE ≤ grade2.
- Inability to swallow tablets or gastrointestinal disease, possible impairment of adequate absorption of study drugs.
- Have severe cardiac disease:NYHA class ≥grade II heart failure; unstable angina pectoris；myocardial infarction within 12 months； clinically significant supraventricular or ventricular arrhythmias require treatment or intervention; Hypertension that cannot be well controlled by antihypertensive medication (systolic blood pressure ≥150 mmHg or diastolic blood pressure ≥100 mmHg).
- Known active hepatitis C virus, or known active hepatitis B virus.
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- Allergic to the HRS2398 or the similar drug.
- Concurrent anticancer treatment or use of other investigational product within 4 weeks before start of trial treatment; major surgery, radiotherapy, chemotherapy within 4 weeks before 1st dose of trial treatment.
- The patient is currently using a drug known to be a strong inhibitor of CYP3A4 within 2 weeks before 1st dose of study drug ，or strong inducer of CYP3A4 within 4 weeks before 1st dose of study drug .
- The investigator determined that the patient should not participate in the study.
Trial locations and contacts
1 site in 1 country.
China1 site
Affiliated Cancer Hospital of Zhengzhou University/Henan Cancer Hospital
Zhengzhou, Henan, 450000
About this study
Official title: A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK) of HRS2398 in Subjects With Advanced Malignant Tumors
The study is being conducted to determine the dose limited toxicity(DLT) and maximum tolerated dose(MTD) and recommended Phase 2 dose(RP2D) of HRS2398 in subjects with advanced malignant tumor ; The second objectives is to evaluate safety and preliminary efficacy and PK profile of HRS2398 in subjects with advanced malignant tumor ; Exploratory cohort is to explore the relationship between gene mutation and efficacy and resistance mechanisms.
- Conditions
- Advanced Malignant Tumor
- Being tested
- HRS2398 Tablets
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HRS2398 TabletsDrug
Take 5mg to 320mg once or twice a day ; Oral administration , 21 days as a cycle.
| Study group | Role | What they receive |
|---|---|---|
| Single Arm | Experimental | HRS2398 Tablets Receives: Drug: HRS2398 Tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-limiting toxicity（DLT）
Measured: up to 21 days
Maximum tolerated dose（MTD）
Measured: up to 6 months
Recommended Phase II Dose (RP2D)
Measured: up to 21 days
Secondary outcomes (16)
Number of subjects with adverse events and the severity of adverse events
Measured: from the first drug administration to within 30 days for the last treatment dose
Cmax of HRS2398 of Single administration
Measured: Single administration : 30min before administration of Day1, 5min, 0.25 hour, 0.5 hour, 0.75 hour, 1 hour , 2hours, 4hours, 6hours, 8hours, 10hours, 24hours, 48hours, 72hours after administration of Day1
Tmax of HRS2398 of Single administration
Measured: Single administration : 30min before administration of Day1, 5min, 0.25 hour, 0.5 hour, 0.75 hour, 1 hour , 2hours, 4hours, 6hours, 8hours, 10hours, 24hours, 48hours, 72hours after administration of Day1
AUC0-t of HRS2398 of Single administration
Measured: ingle administration : 30min before administration of Day1, 5min, 0.25 hour, 0.5 hour, 0.75 hour, 1 hour , 2hours, 4hours, 6hours, 8hours, 10hours, 24hours, 48hours, 72hours after administration of Day1
AUC0-12 of HRS2398 of Single administration
Measured: Single administration : 30min before administration of Day1, 5min, 0.25 hour, 0.5 hour, 0.75 hour, 1 hour , 2hours, 4hours, 6hours, 8hours, 10hours after administration of Day1
T1/2 of HRS2398 of Single administration
Measured: Single administration : 30min before administration of Day1, 5min, 0.25 hour, 0.5 hour, 0.75 hour, 1 hour , 2hours, 4hours, 6hours, 8hours, 10hours, 24hours, 48hours, 72hours after administration of Day1
Cmax of HRS2398 of Multiple doses
Measured: Multiple administration: Day8, Day15, Day17 of Cycle1, Day1 of Cycle2-4 (each cycle is 21 days)
Tmax of HRS2398 of Multiple administration
Measured: Multiple administration: Day8, Day15, Day17 of Cycle1, Day1 of Cycle2-4 (each cycle is 21 days)
AUC0-t of HRS2398 of Multiple administration
Measured: Multiple administration: Day8, Day15, Day17 of Cycle1, Day1 of Cycle2-4 (each cycle is 21 days)
AUC0-12 of HRS2398 of Multiple administration
Measured: Multiple administration: Day8, Day15, Day17 of Cycle1, Day1 of Cycle2-4 (each cycle is 21 days)
T1/2 of HRS2398 of Multiple administration
Measured: Multiple administration: Day8, Day15, Day17 of Cycle1, Day1 of Cycle2-4 (each cycle is 21 days)
Bioavailability of fasting state
PK blood samples from subjects were collected for bioavailability ，Postprandial AUC divided by fasting AUC
Measured: up to 4 months
Objective Response Rate(ORR)
Radiological scans performed at baseline then every 6 weeks until objective radiological disease progression
Measured: up to 4 months
Disease Control Rate(DCR)
Complete response + Partial response + Stable disease (CR+PR+SD) based on RECIST 1.1
Measured: up to 4 months
Duration of response (DoR)
Time from documentation of tumor response to disease progression assessed among patients who had an objective response
Measured: up to 4 months
Progression free survival(PFS)
Defined as Progression free survival per RECIST 1.1 criteria according to Investigator's assessment
Measured: up to 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2021
- Study start20 Dec 2021
- Primary completion21 Feb 2024
- Study completion21 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Malignant TumorStudies of the same condition, open and under way.
- More trials run by Shanghai Hengrui Pharmaceutical 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
- Model description
- Single therapy of HRS2398
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Hengrui Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05144061
- Sponsor's protocol ID
- HRS2398-I-101
- Status last verified
- Nov 2022
- First submitted
- 12 Oct 2021
- Last updated
- 18 Dec 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK) of HRS2398 in Subjects With Advanced Malignant Tumors
- ClinicalTrials.gov ID
- NCT05144061
- Acronym / sponsor ID
- HRS2398-I-101
- Conditions
- Advanced Malignant Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Shanghai Hengrui Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 20 Dec 2021 (actual)
- Primary completion
- 21 Feb 2024 (actual)
- Study completion
- 21 Feb 2024 (actual)
- First posted
- 3 Dec 2021 (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.
The study is being conducted to determine the dose limited toxicity(DLT) and maximum tolerated dose(MTD) and recommended Phase 2 dose(RP2D) of HRS2398 in subjects with advanced malignant tumor ; The second objectives is to evaluate safety and preliminary efficacy and PK profile of HRS2398 in subjects with advanced malignant tumor ; Exploratory cohort is to explore the relationship between gene mutation and efficacy and resistance mechanisms.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single therapy of HRS2398
| Arm | Type | Receives |
|---|---|---|
| Single Arm | Experimental | Drug: HRS2398 TabletsHRS2398 Tablets |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Subjects are able to give voluntary informed consent, understand the study and are willing to follow and complete all the test procedures.
- subjects ≥18 years and ≤70 years.
- Patients with Histologically or cytologically confirmed advanced Malignant tumors who had failed standard treatment or had not been treated with standard therapy.
- ECOG ≤1.
- Subjects with life expectancy of ≥ 3 months.
Key exclusion criteria (10 listed)
- Untreated and/or uncontrolled brain metastases.
- Patients with clinical symptoms of cancer ascites, pleural effusion, who need to drainage, or who have undergone ascites drainage within 2 weeks prior to the first administration.
- Failure to recover from adverse events from the most recent anti-tumor treatment to CTCAE ≤ grade2.
- Inability to swallow tablets or gastrointestinal disease, possible impairment of adequate absorption of study drugs.
- Have severe cardiac disease:NYHA class ≥grade II heart failure; unstable angina pectoris；myocardial infarction within 12 months； clinically significant supraventricular or ventricular arrhythmias require treatment or intervention; Hypertension that cannot be well controlled by antihypertensive medication (systolic blood pressure ≥150 mmHg or diastolic blood pressure ≥100 mmHg).
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 |
|---|---|---|
| HRS2398 TabletsTake 5mg to 320mg once or twice a day ; Oral administration , 21 days as a cycle. | Drug | Single Arm |
Primary outcome
Dose-limiting toxicity（DLT）
Time frame: up to 21 days
Maximum tolerated dose（MTD）
Time frame: up to 6 months
Recommended Phase II Dose (RP2D)
Time frame: up to 21 days
16 secondary outcomes
Number of subjects with adverse events and the severity of adverse events
Time frame: from the first drug administration to within 30 days for the last treatment dose
Cmax of HRS2398 of Single administration
Time frame: Single administration : 30min before administration of Day1, 5min, 0.25 hour, 0.5 hour, 0.75 hour, 1 hour , 2hours, 4hours, 6hours, 8hours, 10hours, 24hours, 48hours, 72hours after administration of Day1
Tmax of HRS2398 of Single administration
Time frame: Single administration : 30min before administration of Day1, 5min, 0.25 hour, 0.5 hour, 0.75 hour, 1 hour , 2hours, 4hours, 6hours, 8hours, 10hours, 24hours, 48hours, 72hours after administration of Day1
AUC0-t of HRS2398 of Single administration
Time frame: ingle administration : 30min before administration of Day1, 5min, 0.25 hour, 0.5 hour, 0.75 hour, 1 hour , 2hours, 4hours, 6hours, 8hours, 10hours, 24hours, 48hours, 72hours after administration of Day1
AUC0-12 of HRS2398 of Single administration
Time frame: Single administration : 30min before administration of Day1, 5min, 0.25 hour, 0.5 hour, 0.75 hour, 1 hour , 2hours, 4hours, 6hours, 8hours, 10hours after administration of Day1
T1/2 of HRS2398 of Single administration
Time frame: Single administration : 30min before administration of Day1, 5min, 0.25 hour, 0.5 hour, 0.75 hour, 1 hour , 2hours, 4hours, 6hours, 8hours, 10hours, 24hours, 48hours, 72hours after administration of Day1
Cmax of HRS2398 of Multiple doses
Time frame: Multiple administration: Day8, Day15, Day17 of Cycle1, Day1 of Cycle2-4 (each cycle is 21 days)
Tmax of HRS2398 of Multiple administration
Time frame: Multiple administration: Day8, Day15, Day17 of Cycle1, Day1 of Cycle2-4 (each cycle is 21 days)
AUC0-t of HRS2398 of Multiple administration
Time frame: Multiple administration: Day8, Day15, Day17 of Cycle1, Day1 of Cycle2-4 (each cycle is 21 days)
AUC0-12 of HRS2398 of Multiple administration
Time frame: Multiple administration: Day8, Day15, Day17 of Cycle1, Day1 of Cycle2-4 (each cycle is 21 days)
T1/2 of HRS2398 of Multiple administration
Time frame: Multiple administration: Day8, Day15, Day17 of Cycle1, Day1 of Cycle2-4 (each cycle is 21 days)
Bioavailability of fasting state
Time frame: up to 4 months
Objective Response Rate(ORR)
Time frame: up to 4 months
Disease Control Rate(DCR)
Time frame: up to 4 months
Duration of response (DoR)
Time frame: up to 4 months
Progression free survival(PFS)
Time frame: up to 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2024.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HRS2398 Tablets in people with Advanced Malignant Tumor, run by Shanghai Hengrui Pharmaceutical Co., Ltd. at 1 site 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 18 inclusion and 10 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: finished, as of the sponsor's last update on 18 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose-limiting toxicity（DLT） (time frame: up to 21 days). The study lists 3 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 18 Dec 2024.