Advanced Malignant Tumour
Conditions
Brief summary
This study is a multicentre, open phase II clinical study of dose escalation, dose extension and efficacy extension of HRS-7058 in combination with antitumor drugs in subjects with advanced malignant tumour. To evaluate the safety, tolerability and efficacy of HRS-7058 in combination with antitumor drugs.
Interventions
DRUGHRS-7058 + SHR-1316
HRS-7058 + SHR-1316
DRUGHRS-7058 + SHR-1316 + Platinum-containing doublet chemotherapy
HRS-7058 + SHR-1316 + Platinum-containing doublet chemotherapy
DRUGHRS-7058 + Cetuximab
HRS-7058 + Cetuximab
DRUGHRS-7058 + SHR-1826
HRS-7058 + SHR-1826
DRUGHRS-7058 + SHR-1826 + SHR-1316
HRS-7058 + SHR-1826 + SHR-1316
DRUGHRS-7058 + SHR-A1202
HRS-7058 + SHR-A1202
DRUGHRS-7058 + BP102
HRS-7058 + BP102
DRUGHRS-7058 + SHR-9839
HRS-7058 + SHR-9839
DRUGHRS-7058 +SHR-A2102 +SHR-1316
HRS-7058 +SHR-A2102 +SHR-1316
DRUGHRS-7058 +SHR-9839(sc)+SHR-1316
HRS-7058 +SHR-9839(sc)+SHR-1316
DRUGHRS-7058 +SHR-1316 +BP102
HRS-7058 +SHR-1316 +BP102
DRUGHRS-7058 +SHR-A2102 +BP102
HRS-7058 +SHR-A2102 +BP102
DRUGHRS-7058 +SHR-A2102 +SHR-1316 +BP102
HRS-7058 +SHR-A2102 +SHR-1316 +BP102
Sponsors
Shandong Suncadia Medicine Co., Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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 unresectable 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 12 weeks; 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. 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 be negative; and they must not be lactating. Female subjects of childbearing potential and male subjects whose partners are females of childbearing potential must agree to comply with contraceptive requirements from the time of signing the informed consent form until 5 months after the last administration of the study drug (for male subjects) or 8 months after the last administration of the study drug (for female subjects).
Exclusion criteria
1. Accompanied by untreated or active central nervous system (CNS) tumour metastasis; 2. Antitumor therapy within 28 days prior to initial use of the investigational drug; 3. The adverse reactions of previous anti-tumour therapy have not recovered to CTCAE ≤ grade 1; 4. With known or suspected interstitial pneumonia; 5. With severe cardiovascular and cerebrovascular disease 6. Had other malignancies within five years prior to first use of the investigational drug; 7. Severe infection within 28 days prior to first use of the investigational drug; 8. History of immune deficiency; 9. Refractory nausea, vomiting, or other gastrointestinal disorders that affect the use of oral medications; 10. The presence of uncontrolled pleural, abdominal or pericardial effusion; 11. Had undergone major organ surgery within 28 days prior to the first use of the study drug; 12. Women during pregnancy or lactation; 13. Known allergies and contraindications to the investigational drug or any of its components; 14. According to the judgment of the investigator, there are any other circumstances that may increase the risks of participating in the study, interfere with the study results, or make the subjects unsuitable for participating in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dose-limiting toxicity (DLT) (Dose Escalation and Dose Expansion) | From the beginning of first patient in (FPI) to the end of dose expansion phase up to approximately 10 months |
| Safety endpoints: adverse events (AE) (Dose Escalation and Dose Expansion) | From the beginning of first patient in (FPI) to the end of dose expansion phase up to approximately 10 months] |
| Phase II recommended dose (RP2D)(Dose Escalation and Dose Expansion) | From the beginning of first patient in (FPI) to the end of dose expansion phase up to approximately 10 months] |
| Efficacy endpoints: Objective response rate (ORR) assessed based on RECIST v1.1 criterion (Efficacy Expansion) | From the beginning of first patient in (FPI) to the end of study up to approximately 32 months |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy endpoints: Objective response rate (ORR) assessed based on RECIST v1.1 criterion (Dose Escalation and Dose Expansion) | From the beginning of first patient in (FPI) to the end of dose expansion phase up to approximately 10 months |
| Efficacy endpoints: disease control rate (DCR) assessed based on RECIST v1.1 criterion (Dose Escalation and Dose Expansion) | From the beginning of first patient in (FPI) to the end of dose expansion phase up to approximately 10 months |
| Efficacy endpoints: duration of response (DoR) assessed based on RECIST v1.1 criterion (Dose Escalation and Dose Expansion) | From the beginning of first patient in (FPI) to the end of dose expansion phase up to approximately 10 months |
| Efficacy endpoints: progression-free survival (PFS) assessed based on RECIST v1.1 criterion (Dose Escalation and Dose Expansion) | From the beginning of first patient in (FPI) to the end of dose expansion phase up to approximately 10 months |
| Efficacy endpoints: overall survival (OS)(Dose Escalation and Dose Expansion) | From the beginning of first patient in (FPI) to the end of dose expansion phase up to approximately 10 months |
| Efficacy endpoints: disease control rate (DCR) assessed based on RECIST v1.1 criterion (Efficacy Expansion) | From the beginning of first patient in (FPI) to the end of study up to approximately 32 months |
| Efficacy endpoints: duration of response (DoR) assessed based on RECIST v1.1 criterion (Efficacy Expansion) | From the beginning of first patient in (FPI) to the end of study up to approximately 32 months |
| Efficacy endpoints: progression-free survival (PFS) assessed based on RECIST v1.1 criterion (Efficacy Expansion) | From the beginning of first patient in (FPI) to the end of study up to approximately 32 months |
| Efficacy endpoints: overall survival (OS) (Efficacy Expansion) | From the beginning of first patient in (FPI) to the end of study up to approximately 32 months |
| Safety endpoints: adverse events (AE)(Efficacy Expansion) | From the beginning of first patient in (FPI) to the end of study up to approximately 32 months |
Countries
China
Contacts
CONTACTSida Zhu
CONTACTLinan Wang
Outcome results
None listed