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

Study Overview
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Brief Summary
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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)

Official Title
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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

Conditions
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Advanced Malignant Cancer

Intervention / Treatment
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* Drug: HRS-7053 Injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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 &gt; 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HRS-7053 Injection<br> | Drug: HRS-7053 Injection<br>* HRS-7053 is administered by intravenous (IV) infusion once a week (QW) for one treatment cycle every 4 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence and severity of adverse events (AES) |  | up to 3 years | 
| MTD |  | up to 3 years | 
| RP2D |  | up to 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Progression-free survival (PFS) |  | up to 3 years | 
| Duration of response (DoR) |  | up to 3 years | 
| Overall survival (OS) |  | up to 3 years |