A Phase I Clinical Study of HRS-7058 in Patients With Advanced Malignant Tumour

  • STATUS
    Recruiting
  • days left to enroll
    33
  • participants needed
    233
  • sponsor
    Shandong Suncadia Medicine Co., Ltd.
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Updated on 11 February 2026
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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.

Details
Condition Advanced Malignant Tumour
Age 18years - 75years
Clinical Study IdentifierNCT06383871
SponsorShandong Suncadia Medicine Co., Ltd.
Last Modified on11 February 2026

Eligibility

 Yes No Not Sure

Inclusion Criteria

The subjects gave informed consent to the study before participating in, and voluntarily signed informed consent
18 to 75 years old (including both ends), gender is not limited
Subjects with locally advanced or metastatic solid tumour confirmed by histopathology
Having at least one evaluable or measurable lesion according to the solid tumour response Evaluation Criteria (RECIST 1.1)
ECOG Performance Status of 0 or 1
The expected survival time is more than 3 months
Be able to ingest drugs and be able to comply with trial and follow-up procedures
Adequate bone marrow and organ function
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
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

Accompanied by untreated or active central nervous system (CNS) tumour metastasis
Had other malignancies within five years prior to first use of the investigational drug
With severe cardiovascular and cerebrovascular disease；
Refractory nausea, vomiting, or other gastrointestinal disorders that affect the use of oral medications
The presence of uncontrolled pleural, abdominal or pericardial effusion
Severe infection within 4 weeks prior to initiation of study treatment
History of immune deficiency
The adverse reactions of previous anti-tumour therapy have not recovered to CTCAE ≤ grade 1
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
Had undergone major organ surgery within 4 weeks prior to the first use of the study drug
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
Known allergies and contraindications to the investigational drug or any of its components
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
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