A Study of HRS2543 in Patients With Advanced Tumors

NCT05068856 | Terminated Phase 1

• 1 other identifier: HRS2543-I-101
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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

Conditions

Advanced Tumors

Outcome Measures

Primary Outcomes (3)

• Dose-Limiting Toxicity (DLT)

  A DLT is considered at AE related to study drug unless there is a clear, well-documented, alternative explanation for the toxicity. Severity of AEs are graded according to the NCI CTCAE 5.0 for the study, the occurrence of the following drug related AEs during the single dose and the first cycle (28 days) will be considered a DLT by the investigator and SMC.

  Day 1 to 28 (Cycle 1)

• Maximum Tolerated Dose (MTD)

  Toxicity will be evaluated according to the NCI CTCAE Version 5.0.

  Day 1 to 28 (Cycle 1)

• Recommended PhaseII Dose (RP2D)

  Toxicity will be evaluated according to the NCI CTCAE Version 5.0.

  Day 1 to 28 (Cycle 1)

Secondary Outcomes (22)

• Number of patients with changes in laboratory measurements

  up to 24 months

• Number of patients with changes in single and triplicate 12-lead Electrocardiogram (ECG).

  up to 24 months

• Number of patients with changes in ECOG PS score.

  up to 24 months

• Number of patients with changes in Physical Examination.

  up to 24 months

• Number of patients with changes in Vital Signs

  up to 24 months

Study Arms (1)

HRS2543

EXPERIMENTAL

Drug: HRS2543

Interventions

HRS2543 DRUG

Dose-escalation part For the dose-escalation study, five dose cohorts (25 mg , 75 mg , 150 mg , 300 mg , and 450 mg ) of HRS2543 are initially set. Dose-expansion part After the completion of dose-escalation study, the dose-expansion study will be carried out at the recommended dose level by the SMC.

HRS2543

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Any previous anti-tumor treatment
• The toxicity caused by any previous anti-tumor treatment has not recovered to ≤ grade 1
• Any other anti-tumor treatment is planned during the study treatment
• After imaging diagnosis, there were brain tumor lesions
• 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
• Active heart disease was present within 6 months before the first administration of the study
• Other malignancies occurred within 5 years before the first administration of the study
• Active HBV or HCV infection
• The subject had a history of immune deficiency
• 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

Sponsors & Collaborators

• Shanghai Hengrui Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Shanghai Jiao Tong University School of Medicine, Ruijin Hospital

Shanghai, Shanghai Municipality, 200025, China

Location

Study Design

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

Model Details: HRS2543 monotherapy

Study Record Dates

• First Submitted: September 15, 2021
• First Posted: October 6, 2021
• Study Start: December 28, 2021
• Primary Completion: May 15, 2024
• Study Completion: May 15, 2024
• Last Updated: July 18, 2024

Record last verified: 2024-07

Locations

CN (1)