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

Hengrui Medicine

Status and phase

Withdrawn

Phase 1

Conditions

Advanced Malignant Cancer

Treatments

Drug: HRS-7053 Injection

Study type

Interventional

Funder types

Industry

Identifiers

NCT05983146

HRS-7053-101

Details and patient eligibility

About

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)

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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 > 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