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

NCT05983146 | Withdrawn Phase 1

• 1 other identifier: HRS-7053-101
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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)

Conditions

Advanced Malignant Cancer

Outcome Measures

Primary Outcomes (3)

• Incidence and severity of adverse events (AES)

  up to 3 years

• MTD

  up to 3 years

• RP2D

  up to 3 years

Secondary Outcomes (8)

• Time to maximum concentration (Tmax)

  up to 3 years

• Maximum concentration (Cmax)

  up to 3 years

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

  up to 3 years

• Objective response rate （ORR）

  up to 3 years]

• Disease control rate (DCR)

  up to 3 years

Study Arms (1)

HRS-7053 Injection

EXPERIMENTAL

Drug: HRS-7053 Injection

Interventions

HRS-7053 Injection DRUG

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

HRS-7053 Injection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2023
• First Posted: August 9, 2023
• Study Start: September 1, 2023
• Primary Completion: May 30, 2025
• Study Completion: May 30, 2025
• Last Updated: July 24, 2025

Record last verified: 2025-07