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WithdrawnNCT05983146Updated Jul 24, 2025

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

A Phase 1 interventional study of HRS-7053 Injection in Advanced Malignant Cancer, sponsored by Jiangsu HengRui Medicine Co., Ltd.. Withdrawn. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-07-24.

Sponsored by Jiangsu HengRui Medicine Co., Ltd. · Phase 1, Interventional, and Treatment

Why this study was withdrawn
The sponsor's R\&D strategy is adjusted.
Phase
Phase 1
Study type
Interventional
Enrollment
0
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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)

02

Conditions studied

  • Advanced Malignant Cancer
03

In context

Lead sponsor

Jiangsu HengRui Medicine Co., Ltd. is the lead sponsor of 559 studies on the registry; 85 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 1 (11%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Voluntary participation in this study, signed informed consent, compliance is good, can cooperate with follow-up
  2. Age ≥18 years, both male and female
  3. Histologically or cytologically confirmed patients with advanced hematologic malignancies that have not responded to standard antitumor therapy and currently indicate treatment
  4. Have measurable lesions
  5. ECOG PS score: 0-1
  6. Have a life expectancy of at least 3 months
  7. The functional level of the major organs must meet the requirements
  8. 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

Exclusion criteria

Exclusion Criteria:

  1. The tumor infiltrates the central nervous system
  2. 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
  3. Had major surgery or severe trauma 4 weeks prior to the first study; Or plan to undergo major surgery during the study
  4. 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
  5. 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
  6. 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
  7. Previous treatment-induced adverse events did not recover to ≤CTCAE grade 1
  8. Participating in other clinical studies or signing informed consent less than 1 month after the last medication in the previous clinical study
  9. The active phase of HBV or HCV infection is known
  10. A history of immunodeficiency, including HIV seropositive, or other acquired, congenital immunodeficiency disorders
  11. Active infection or unexplained fever > 38.5 ° c
  12. A history of clinically severe cardiovascular disease; A history of myocarditis within one year prior to drug administration was first studied
  13. The abnormality of electrocardiogram (ECG) was clinically significant
  14. In the first study, cerebrovascular accident, transient ischemic attack occurred within 6 months prior to drug administration
  15. History of other malignancies within 5 years prior to drug administration was first studied
  16. Known allergy to any component of the HRS-7053 product
  17. 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
  18. Female subjects are pregnant or breastfeeding
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    HRS-7053 Injection

    Drug: HRS-7053 Injection

Interventions

  • DrugHRS-7053 Injection

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

06

What researchers measure

Primary outcomes

  1. Incidence and severity of adverse events (AES)

    Time frame: up to 3 years

  2. MTD

    Time frame: up to 3 years

  3. RP2D

    Time frame: up to 3 years

Secondary outcomes

  1. Time to maximum concentration (Tmax)

    Time frame: up to 3 years

  2. Maximum concentration (Cmax)

    Time frame: up to 3 years

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

    Time frame: up to 3 years

  4. Objective response rate (ORR)

    Time frame: up to 3 years]

  5. Disease control rate (DCR)

    Time frame: up to 3 years

  6. Progression-free survival (PFS)

    Time frame: up to 3 years

  7. Duration of response (DoR)

    Time frame: up to 3 years

  8. Overall survival (OS)

    Time frame: up to 3 years

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 24, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05983146
Lead sponsor
Jiangsu HengRui Medicine Co., Ltd.
Responsible party
Sponsor
First posted
Aug 9, 2023
Start date
Sep 1, 2023
Primary completion
May 30, 2025
Completion
May 30, 2025
Last update
Jul 24, 2025

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.

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