Advanced Solid Tumors
Conditions
Brief summary
The study is being conducted to evaluate the safety, tolerability, pharmacokinetics and efficacy of SHR-4602 as montherapy or in combination with other anti-tumor therapies in advanced solid tumors. To explore the reasonable dosage of SHR-4602 for advanced solid tumors.
Interventions
DRUGSHR-4602
SHR-4602
Sponsors
Shanghai Hengrui Pharmaceutical Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. 18-80 years old; 2. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; 3. Stage I: subjects with pathologically confirmed locally advanced unresectable or metastatic solid tumors, who have failed at least 1 line of standard treatment; 4. Provide archived or fresh tumor tissue；HER2 expression is required for subjects in Stage I; 5. At least one measurable lesion according to RECIST v1.1； 6. Expected survival ≥12 weeks 7. Good level of organ function； 8. Female subjects of childbearing potential must have a negative serum pregnancy test within 7 days prior to the first dose, be non-lactating. Male subjects whose partners are women of childbearing age and female subjects who are fertile must agree to avoid sperm or egg donation during the treatment period until 8 months after the last dose of the investigational drug; 9. Have the ability to give informed consent, have signed informed and able to comply with the treatment plan to visit the tests and other procedural requirements；
Exclusion criteria
1. Inadequately treated central nervous system metastases or the presence of uncontrolled or symptomatic active central nervous system metastases； 2. Subjects with peripheral neuropathy； 3. Have received anti-cancer treatment within 4 weeks prior the first dose of study treatment; 4. Are participating in another clinical study or have received the last dose in a clinical study less than 4 weeks from the first dose; 5. Subjects who have received systemic immunosuppressant treatment within 14 days prior the first dose of study treatment; 6. Have received treatment with strong CYP3A inducers or inhibitors, or P-gp inhibitors or inducers within 5 half-lives prior to the first dose; 7. Toxicity and/or complications of previous antitumor therapy has not resolved to NCI-CTCAE level ≤1 or
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ORR by investigator assessment | Up to approximately 5 years; | ORR by investigator assessment was defined as the percentage of participants with confirmed complete response (CR) or partial response (PR), Up to approximately 5 years; |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| DCR by investigator assessment, | Up to approximately 5 years; | DCR by investigator assessment was defined as the percentage of participants with confirmed response (CR or PR), or SD, per RECIST v1.1 per investigator, Up to approximately 5 years; |
| DoR by investigator assessment, | Up to approximately 5 year | DoR was defined as the time from the first objective response (CR or PR that is subsequently confirmed) to the first documented PD per RECIST v1.1 per investigator or death from any cause, whichever occurs first, Up to approximately 5 years; |
| PFS by investigator assessment, | Up to approximately 5 years; | PFS was defined as the time from date of start of study treatment to first documentation of disease progression (PD), or to death due to any cause, whichever occurred first, Up to approximately 5 years; |
| OS | Up to approximately 5 years; | OS is defined as the time from start of study treatment to death from any cause, Up to approximately 5 years; |
| Number of participants with adverse events (AEs), | Up to approximately 5 years; | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship, Up to approximately 5 years; |
Countries
China
Contacts
Primary ContactFan Liang
Outcome results
None listed