Phase
Condition
Neoplasms
Treatment
HRS-7058 + Cetuximab
HRS-7058 + SHR-1316
HRS-7058 + SHR-1826 + SHR-1316
Clinical Study ID
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
The subjects gave informed consent to the study before participating in, andvoluntarily signed informed consent;
18 to 75 years old (including both ends), gender is not limited;
Subjects with unresectable locally advanced or metastatic solid tumour confirmed byhistopathology;
Having at least one evaluable or measurable lesion according to the solid tumourresponse Evaluation Criteria (RECIST 1.1);
ECOG Performance Status of 0 or 1;
The expected survival time is more than 12 weeks;
Be able to ingest drugs and be able to comply with trial and follow-up procedures;
Adequate bone marrow and organ function;
Female subjects of childbearing potential must undergo a serum pregnancy test within 7 days before the first administration of the study drug, and the result must benegative; and they must not be lactating. Female subjects of childbearing potentialand male subjects whose partners are females of childbearing potential must agree tocomply with contraceptive requirements from the time of signing the informed consentform until 5 months after the last administration of the study drug (for malesubjects) or 8 months after the last administration of the study drug (for femalesubjects).
Exclusion
Exclusion Criteria:
Accompanied by untreated or active central nervous system (CNS) tumour metastasis;
Antitumor therapy within 28 days prior to initial use of the investigational drug;
The adverse reactions of previous anti-tumour therapy have not recovered to CTCAE ≤grade 1;
With known or suspected interstitial pneumonia;
With severe cardiovascular and cerebrovascular disease
Had other malignancies within five years prior to first use of the investigationaldrug;
Severe infection within 28 days prior to first use of the investigational drug;
History of immune deficiency;
Refractory nausea, vomiting, or other gastrointestinal disorders that affect the useof oral medications;
The presence of uncontrolled pleural, abdominal or pericardial effusion;
Had undergone major organ surgery within 28 days prior to the first use of the studydrug;
Women during pregnancy or lactation;
Known allergies and contraindications to the investigational drug or any of itscomponents;
According to the judgment of the investigator, there are any other circumstancesthat may increase the risks of participating in the study, interfere with the studyresults, or make the subjects unsuitable for participating in this study.
Study Design
Connect with a study center
Tianjin Cancer Hospital
Tianjin, Tianjin 300060
ChinaActive - Recruiting

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