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Advanced Malignant TumorPhase 1NCT05318833

A Study of HRS7415 Tablets in Patients With Advanced Malignant Tumors

A Phase 1 study testing HRS7415 in people with Advanced Malignant Tumor, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study is a multicenter, open phase I clinical study of dose escalation and dose extension of HRS7415 in subjects with advanced malignant tumors. To evaluate the safety, tolerability, pharmacokinetics and efficacy of HRS7415 tablets. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Advanced Malignant Tumor
What is being tested?
HRS7415
Could I receive a placebo?
No, everyone receives an active treatment
How many people
38 participants
Where
1 siteChina
Study dates
12 May 2022to 20 Mar 2025
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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subjects volunteered to participate in the clinical study, understood the study procedure and was able to sign informed consent in person.
  • 18 to 75 years old, male or female.
  • ECOG Performance Status of 0 or 1.
  • The estimated survival time is ≥12 weeks.
  • Subjects with advanced or metastatic malignancy confirmed by histopathology or cytology.
  • Solid tumor subjects had measurable lesions that met RECIST 1.1 criteria.
  • Adequate hematology and terminal organ function, with vital organ function meeting the upper and lower limits required by the protocol.
  • Male subjects and fertile female subjects must agree to use medically approved contraception during the study period and for 6 months following the study; Fertile female subjects must have a negative serum human chorionic gonadotropin (HCG) test within 7 days prior to initial dosing and must be non-lactation blood pregnancy test must be negative and not lactation.

Who cannot join

  • Subjects plan to receive any other antitumor therapy during the study period.
  • Subjects received chemotherapy, radiotherapy, biotherapy, targeted therapy, or immunotherapy within 4 weeks prior to initial dosing.
  • Major surgery other than diagnosis or biopsy was performed within 4 weeks prior to initial dosing.
  • Received any other investigational drug or treatment that is not on the market within 4 weeks prior to initial dosing.
  • The damage caused by any previous antineoplastic therapy has not recovered to grade ≤1.
  • Imaging diagnosis showed tumor lesion or meningeal metastasis in the brain.
Show all 14Show fewer
  • Active heart disease in the 6 months prior to initial dosing.
  • Had other malignancies within 5 years prior to first dosing.
  • Subjects with poorly controlled hypertension and a previous history of hypertensive crisis or hypertensive encephalopathy.
  • Having one of several factors affecting oral medication or having active gastrointestinal disease or other medical conditions that may result in significant influence on drug absorption, distribution, metabolism or excretion;
  • Active hepatitis B and C;
  • Serious infections that require intravenous antibiotics, antivirals or antifungals to control;
  • History of immune deficiency or organ transplantation;
  • Comorbidities or any other conditions that, in the investigator's judgment, seriously endanger patient safety or prevent patients from completing the study.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Cancer Hospital Affiliated to Shandong First Medical University

    Jinan, Shandong, 250021

Other trials in China

About this study

Official title: A Phase I Clinical Study on the Safety, Tolerability, Pharmacokinetics and Efficacy of HRS7415 Tablets in Patients With Advanced Malignant Tumors

This study is a multicenter, open phase I clinical study of dose escalation and dose extension of HRS7415 in subjects with advanced malignant tumors. To evaluate the safety, tolerability, pharmacokinetics and efficacy of HRS7415 tablets.

Being tested
HRS7415

What participants receive

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

  • HRS7415Drug

    Drug: HRS7415

Study groups in NCT05318833
Study groupRoleWhat they receive
HRS7415ExperimentalNot described
Receives: Drug: HRS7415

What is being measured

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

  1. Dose-limiting toxicity (DLT)

    Measured: From the beginning of first patient in (FPI) to the end of dose escalation phase up to approximately 10 months

  2. maximum tolerated dose (MTD)

    Measured: From the beginning of first patient in (FPI) to the end of dose escalation phase up to approximately 10 months

  3. Phase II recommended dose (RP2D)

    Measured: From the beginning of first patient in (FPI) to the end of dose escalation phase up to approximately 10 months

Secondary outcomes (17)

  1. Incidence, severity, duration, and association of adverse events (AE) and severe adverse events (SAE) with the study drug, in addition to abnormalities in vital signs, electrocardiogram, and laboratory tests

    Measured: From the beginning of first patient in (FPI) to the end of study up to approximately 2 years

  2. Single dose parameters: Peak plasma concentration (Cmax) of HRS7415 and its main metabolite after single dosing

    Measured: From the beginning of first patient in (FPI) to the end of study up to approximately 2 years

  3. Single dose parameters: Time to peak (Tmax) of HRS7415 and its main metabolite after single dosing

    Measured: From the beginning of first patient in (FPI) to the end of study up to approximately 2 year

  4. Single dose parameters: Area under the curve from 0 to the last measurable concentration time point t (AUC0-t) of HRS7415 and its main metabolite after single dosing (if applicable)

    Measured: From the beginning of first patient in (FPI) to the end of study up to approximately 2 years

  5. Single dose parameters: Area under the time curve from 0 to infinity (AUC0-inf) of HRS7415 and its main metabolite after single dosing (if applicable)

    Measured: From the beginning of first patient in (FPI) to the end of study up to approximately 2 years

  6. Single dose parameters: Half-value period (t1/2) of HRS7415 and its main metabolite after single dosing (if applicable)

    Measured: From the beginning of first patient in (FPI) to the end of study up to approximately 2 years

  7. Single dose parameters: Apparent volume of distribution (Vz/F) of HRS7415 and its main metabolite after single dosing (if applicable)

    Measured: From the beginning of first patient in (FPI) to the end of study up to approximately 2 years

  8. Single dose parameters: Apparent clearance (CL/F) of HRS7415 and its main metabolite after single dosing (if applicable)

    Measured: From the beginning of first patient in (FPI) to the end of study up to approximately 2 years

  9. Multiple dose parameters: Steady state peak concentration (Cmax，ss) of HRS7415 and its main metabolite after multiple dosing

    Measured: From the beginning of first patient in (FPI) to the end of study up to approximately 2 years

  10. Multiple dose parameters: Time to peak (Tmax, ss) of HRS7415 and its main metabolite after multiple dosing

    Measured: From the beginning of first patient in (FPI) to the end of study up to approximately 2 years

  11. Multiple dose parameters: Steady valley concentration (Cmin，ss) of HRS7415 and its main metabolite after multiple dosing

    Measured: From the beginning of first patient in (FPI) to the end of study up to approximately 2 years

  12. Multiple dose parameters: Area under steady-state drug concentration-time curve (AUCss) of HRS7415 and its main metabolite after multiple dosing

    Measured: From the beginning of first patient in (FPI) to the end of study up to approximately 2 years

  13. Multiple dose parameters: Drug storage ratio (Rac) of HRS7415 and its main metabolite after multiple dosing

    Measured: From the beginning of first patient in (FPI) to the end of study up to approximately 2 years

  14. Efficacy endpoints: Objective response rate (ORR)

    Measured: From the beginning of first patient in (FPI) to the end of study up to approximately 2 years

  15. Efficacy endpoints: Disease control rate (DCR)

    Measured: From the beginning of first patient in (FPI) to the end of study up to approximately 2 years

  16. Efficacy endpoints: Duration of response (DoR)

    Measured: From the beginning of first patient in (FPI) to the end of study up to approximately 2 years

  17. Efficacy endpoints: Progression-free survival (PFS)

    Measured: From the beginning of first patient in (FPI) to the end of study up to approximately 2 years

Timeline

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

  1. First posted8 Apr 2022
  2. Study start12 May 2022
  3. Primary completion20 Mar 2025
  4. Study completion20 Mar 2025

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
Model description
The study was divided into two phases, the dose escalation phase and the dose extension phase of HRS7415 in subjects with advanced malignant tumors.
Masking
None (open label)
Enrolment
38 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05318833
Sponsor's protocol ID
HRS7415-I-101
Status last verified
Mar 2026
First submitted
18 Mar 2022
Last updated
13 Mar 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing HRS7415 in people with Advanced Malignant Tumor, run by Jiangsu HengRui Medicine 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 8 inclusion and 14 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 13 Mar 2026. 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: From the beginning of first patient in (FPI) to the end of dose escalation phase up to approximately 10 months). 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?

On the ClinicalTrials.gov record for NCT05318833.

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 13 Mar 2026.

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