Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
PHASE1
10 participants
INTERVENTIONAL
2021-12-28
2024-05-15
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Phase I Study of HRS-4642 in Patients With Advanced Solid Tumors Harboring KRAS G12D Mutation
NCT05533463
A Study of HRS-4642 in Combination With Antineoplastic Agents in Advanced Solid Tumors
NCT06520488
Study of HRS-1167 as Monotherapy in Patients With Advanced Solid Tumors
NCT05473624
Clinical Trial of HRS-4642 Plus SHR-A2102 in Patients With Advanced Solid Tumors
NCT06955390
A Phase I Clinical Study of the Safety， Tolerability，Pharmacokinetics, and Initial Efficacy of HRS-6209 Monotherapy in Patients With Advanced Solid Tumors
NCT05781048
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
HRS2543
HRS2543
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
HRS2543
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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
18 Years
70 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Shanghai Hengrui Pharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Shanghai Jiao Tong University School of Medicine, Ruijin Hospital
Shanghai, Shanghai Municipality, China
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
HRS2543-I-101
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.