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Trial Title:
A Phase I Clinical Study of HRS-7058 in Patients With Advanced Malignant Tumour
NCT ID:
NCT06383871
Condition:
Advanced Malignant Tumour
Conditions: Official terms:
Neoplasms
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
HRS-7058 capsule/ HRS-7058 tablet
Description:
HRS-7058 capsule/ HRS-7058 tablet
Arm group label:
HRS-7058
Summary:
This study is a multicentre, open phase I clinical study of dose escalation, dose
extension and efficacy extension of HRS-7058 in subjects with advanced malignant tumour.
To evaluate the safety, tolerability, pharmacokinetics and efficacy of HRS-7058.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. The subjects gave informed consent to the study before participating in, and
voluntarily signed informed consent;
2. 18 to 75 years old (including both ends), gender is not limited;
3. Subjects with locally advanced or metastatic solid tumour confirmed by
histopathology;
4. Having at least one evaluable or measurable lesion according to the solid tumour
response Evaluation Criteria (RECIST 1.1);
5. ECOG Performance Status of 0 or 1;
6. The expected survival time is more than 3 months;
7. Be able to ingest drugs and be able to comply with trial and follow-up procedures;
8. Adequate bone marrow and organ function;
9. Fertile women must agree to abstain from sex (abstaining from heterosexual
intercourse) or use a highly effective method of contraception for at least one week
from the time they sign an informed consent form until the last dose of the study
drug. The blood HCG test must be negative within 7 days before the start of the
study treatment, and must be non-lactating;
10. For male patients whose partner is a woman of reproductive age, they must agree to
abstain from sex for at least one week from signing the informed consent until the
last dose of the study drug, or to use a highly effective method of contraception.
Exclusion Criteria:
1. Accompanied by untreated or active central nervous system (CNS) tumour metastasis;
2. Had other malignancies within five years prior to first use of the investigational
drug;
3. With severe cardiovascular and cerebrovascular disease；
4. Refractory nausea, vomiting, or other gastrointestinal disorders that affect the use
of oral medications;
5. The presence of uncontrolled pleural, abdominal or pericardial effusion;
6. Severe infection within 4 weeks prior to initiation of study treatment;
7. History of immune deficiency;
8. The adverse reactions of previous anti-tumour therapy have not recovered to CTCAE ≤
grade 1;
9. Antitumor therapy such as chemotherapy, biotherapy, targeted therapy, immunotherapy,
or other unmarketed investigational drug therapy within 4 weeks prior to initial use
of the investigational drug;
10. Had undergone major organ surgery within 4 weeks prior to the first use of the study
drug;
11. Women who are pregnant, breastfeeding, or who plan to become pregnant within one
week of their last use of the study drug during the study period;
12. Known allergies and contraindications to the investigational drug or any of its
components;
13. In the investigator's judgment, the subjects had other factors that could have
affected the study results or led to the forced termination of the study.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Start date:
April 2024
Completion date:
June 2026
Lead sponsor:
Agency:
Shandong Suncadia Medicine Co., Ltd.
Agency class:
Industry
Source:
Shandong Suncadia Medicine Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06383871
