Clinical trial NCT05068856: A Study of HRS2543 in Patients With Advanced Tumors
Official title: A Phase I, Multi-Center, Open Label, Dose Escalation/Expansion Study of HRS2543 in Patients With Advanced Tumors
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Advanced Tumors
Lead sponsor: Shanghai Hengrui Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2021-10-06
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: HRS2543 monotherapy
Primary purpose: TREATMENT

Brief summary: To assess the safety and tolerability of HRS2543 in patients with advanced tumors and to determine the recommended phase II dose (RP2D) of HRS2543


Eligibility criteria: Inclusion Criteria:

1. 18-70 years of age, both male and female
2. non standard treatment, invalid the standard treatment or refuse to receive standard treatment in patients with advanced tumors diagnosed by pathology
3. the Eastern Cooperative Oncology Group （ECOG） General status (performance status, PS) of 0-1
4. the expected lifetime ≥ 3 months
5. Has at least one measurable lesion as defined by RECIST v1.1
6. Written informed consent is provided by signing the informed consent form

Exclusion Criteria:

1. Any previous anti-tumor treatment
2. The toxicity caused by any previous anti-tumor treatment has not recovered to ≤ grade 1
3. Any other anti-tumor treatment is planned during the study treatment
4. After imaging diagnosis, there were brain tumor lesions
5. According to the judgment of the researcher, there are factors that can not swallow, chronic diarrhea and intestinal obstruction or other factors that can significantly affect the absorption, distribution, metabolism or excretion of drugs
6. Active heart disease was present within 6 months before the first administration of the study
7. Other malignancies occurred within 5 years before the first administration of the study
8. Active HBV or HCV infection
9. The subject had a history of immune deficiency
10. According to the judgment of the researcher, there are concomitant diseases that seriously endanger the safety of the subjects, confuse the analysis of the test results, or affect the subjects to complete the study

Primary outcomes:
measure: Dose-Limiting Toxicity (DLT)
timeFrame: Day 1 to 28 (Cycle 1)
measure: Maximum Tolerated Dose (MTD)
timeFrame: Day 1 to 28 (Cycle 1)
measure: Recommended PhaseII Dose (RP2D)
timeFrame: Day 1 to 28 (Cycle 1)
Secondary outcomes:
measure: Number of patients with changes in laboratory measurements
timeFrame: up to 24 months
measure: Number of patients with changes in single and triplicate 12-lead Electrocardiogram (ECG).
timeFrame: up to 24 months
measure: Number of patients with changes in ECOG PS score.
timeFrame: up to 24 months
measure: Number of patients with changes in Physical Examination.
timeFrame: up to 24 months
measure: Number of patients with changes in Vital Signs
timeFrame: up to 24 months
measure: Incidence of adverse events (AEs).
timeFrame: up to 24 months
measure: Cmax of HRS2543 after single dose of HRS2543
timeFrame: Day 1 of Cycle 1(each cycle 28 days)
measure: Tmax of HRS2543 after single dose of HRS2543
timeFrame: Day 1 of Cycle 1(each cycle 28 days)
measure: AUC0-t of HRS2543 after single dose of HRS2543
timeFrame: Day 1 of Cycle 1(each cycle 28 days)
measure: AUC0-∞ of HRS2543 after single dose of HRS2543
timeFrame: Day 1 of Cycle 1(each cycle 28 days)
measure: t1/2 of HRS2543 after single dose of HRS2543
timeFrame: Day 1 of Cycle 1(each cycle 28 days)
measure: Vz/F of HRS2543 after single dose of HRS2543
timeFrame: Day 1 of Cycle 1(each cycle 28 days)
measure: CL/F of HRS2543 after single dose of HRS2543
timeFrame: Day 1 of Cycle 1(each cycle 28 days)
measure: Cmax,ss of HRS2543 after multiple dose administration of HRS2543
timeFrame: Up to 4 cycles (each cycle 28 days)
measure: Tmax,ss of HRS2543 after multiple dose administration of HRS2543
timeFrame: Up to 4 cycles (each cycle 28 days)
measure: Cmin,ss of HRS2543 after multiple dose administration of HRS2543
timeFrame: Up to 4 cycles (each cycle 28 days)
measure: AUCss of HRS2543 after multiple dose administration of HRS2543
timeFrame: Up to 4 cycles (each cycle 28 days)
measure: Rac of HRS2543 after multiple dose administration of HRS2543
timeFrame: Up to 4 cycles (each cycle 28 days)
measure: ORR: the Objective Response Rate
timeFrame: up to 24 months
measure: DoR: the Duration of Response
timeFrame: up to 24 months
measure: DCR: the Disease Control Rate
timeFrame: up to 24 months
measure: PFS: the Progression Free Survival
timeFrame: up to 24 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Jiao Tong University School of Medicine, Ruijin Hospital
state: Shanghai
Study officials:
References: