AzTrials
AzTrials

Advanced Malignant CancerPhase 1NCT05983146

Phase I Study of HRS-7053 Injection in the Treatment of Patients With Advanced Malignancies

A Phase 1 study testing HRS-7053 Injection in people with Advanced Malignant Cancer, run by Jiangsu HengRui Medicine Co., Ltd..

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
Search all trials

Trial summary

To evaluate the safety and tolerability of multiple administration of HRS-7053 in patients with advanced malignancies Determine the maximum tolerated dose (MTD, if possible) and the recommended dose for Phase II clinical studies (RP2D) Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Malignant Cancer
What is being tested?
HRS-7053 Injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
1 Sep 2023to 30 May 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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Voluntary participation in this study, signed informed consent, compliance is good, can cooperate with follow-up
  • Age ≥18 years, both male and female
  • Histologically or cytologically confirmed patients with advanced hematologic malignancies that have not responded to standard antitumor therapy and currently indicate treatment
  • Have measurable lesions
  • ECOG PS score: 0-1
  • Have a life expectancy of at least 3 months
  • The functional level of the major organs must meet the requirements
  • Fertile female patients must have a serum pregnancy test within 7 days before the first medication and the result is negative; And must be non-lactating

Who cannot join

  • The tumor infiltrates the central nervous system
  • Received autologous stem cell transplantation within 12 weeks prior to administration of the first study; Patients who have previously received allogeneic bone marrow transplantation or solid organ transplantation; In the first study, Car T cell therapy was administered within 12 weeks prior to drug administration
  • Had major surgery or severe trauma 4 weeks prior to the first study; Or plan to undergo major surgery during the study
  • Received antitumor therapy within 2 weeks prior to administration of the first study drug; Received Chinese herbal therapy within 2 weeks before the first dose of study drug administration; Receiving steroid hormones for antitumor purposes within 7 days before the first dose of the investigational drug administration
  • Use of live attenuated vaccine within 28 days prior to signing the informed consent, or expected to require live attenuated vaccine during the study period to 5 months after the final dose
  • Use of any potent drug that inhibits the liver drug metabolizing enzyme CYP3A for 14 days prior to first administration; Any potent drug that induces the liver drug metabolizing enzyme CYP3A has been used for 28 days prior to first administration
Show all 18Show fewer
  • Previous treatment-induced adverse events did not recover to ≤CTCAE grade 1
  • Participating in other clinical studies or signing informed consent less than 1 month after the last medication in the previous clinical study
  • The active phase of HBV or HCV infection is known
  • A history of immunodeficiency, including HIV seropositive, or other acquired, congenital immunodeficiency disorders
  • Active infection or unexplained fever \> 38.5 ° c
  • A history of clinically severe cardiovascular disease; A history of myocarditis within one year prior to drug administration was first studied
  • The abnormality of electrocardiogram (ECG) was clinically significant
  • In the first study, cerebrovascular accident, transient ischemic attack occurred within 6 months prior to drug administration
  • History of other malignancies within 5 years prior to drug administration was first studied
  • Known allergy to any component of the HRS-7053 product
  • The presence of other serious physical or mental illnesses, abnormal laboratory tests, and other factors that may increase the risk of participating in the study or interfere with the study results; And any other conditions that the investigator deems inappropriate for participation in this study
  • Female subjects are pregnant or breastfeeding

About this study

Official title: A Phase I, Open-label, Multi-center Study to Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of HRS-7053 Injection in Patients With Advanced Malignancies

To evaluate the safety and tolerability of multiple administration of HRS-7053 in patients with advanced malignancies Determine the maximum tolerated dose (MTD, if possible) and the recommended dose for Phase II clinical studies (RP2D)

Being tested
HRS-7053 Injection

What participants receive

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

  • HRS-7053 InjectionDrug

    HRS-7053 is administered by intravenous (IV) infusion once a week (QW) for one treatment cycle every 4 weeks

Study groups in NCT05983146
Study groupRoleWhat they receive
HRS-7053 InjectionExperimentalNot described
Receives: Drug: HRS-7053 Injection

What is being measured

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

  1. Incidence and severity of adverse events (AES)

    Measured: up to 3 years

  2. MTD

    Measured: up to 3 years

  3. RP2D

    Measured: up to 3 years

Secondary outcomes (8)

  1. Time to maximum concentration (Tmax)

    Measured: up to 3 years

  2. Maximum concentration (Cmax)

    Measured: up to 3 years

  3. Area under the time curve from 0 to the last measurable concentration time point t (AUC0-t)

    Measured: up to 3 years

  4. Objective response rate （ORR）

    Measured: up to 3 years]

  5. Disease control rate (DCR)

    Measured: up to 3 years

  6. Progression-free survival (PFS)

    Measured: up to 3 years

  7. Duration of response (DoR)

    Measured: up to 3 years

  8. Overall survival (OS)

    Measured: up to 3 years

Timeline

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

  1. First posted9 Aug 2023
  2. Study start1 Sep 2023
  3. Primary completion30 May 2025
  4. Study completion30 May 2025

Why it stopped: The sponsor's R\&D strategy is adjusted.

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
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05983146
Sponsor's protocol ID
HRS-7053-101
Status last verified
Jul 2025
First submitted
31 Jul 2023
Last updated
24 Jul 2025
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 HRS-7053 Injection in people with Advanced Malignant Cancer, run by Jiangsu HengRui Medicine Co., Ltd..

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 18 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: withdrawn, as of the sponsor's last update on 24 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

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 was withdrawn before enrolling participants, so there are no results.

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?

Incidence and severity of adverse events (AES) (time frame: up to 3 years). 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 NCT05983146.

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 24 Jul 2025.

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