Solid Tumor
Conditions
Brief summary
The study is being conducted to evaluate the safety, tolerability and pharmacokinetics of SHR-4685 in participants with advanced solid tumors.
Interventions
DRUGSHR-4685
SHR-4685, in different doses.
Sponsors
Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Single Group Assignment.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Have fully understood this study and voluntarily signed the informed consent form, with good compliance and cooperation with follow-up; 2. Age 18-75 years, any gender; 3. Performance status ECOG score 0 or 1; 4. Expected survival time greater than 3 months; 5. Presence of at least one measurable lesion according to RECIST 1.1 criteria; 6. Have adequate organ function; 7. Female participants of childbearing potential must have a negative serum pregnancy test within 7 days prior to the first dose; and must not be lactating.
Exclusion criteria
1. Participants who have received any approved anti-tumor drugs (including investigational anti-tumor drugs) within 4 weeks prior to the first dose of the IP; 2. Toxicities from prior anti-tumor therapy have not recovered to ≤ Grade 1 or to the level specified in the inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse events (AEs). | From the first drug administration to within 30 days for the last treatment dose, up to 24 months. |
| Serious adverse events (SAEs). | From the first drug administration to within 30 days for the last treatment dose, up to 24 months. |
| Dose-limiting toxicity (DLT) of SHR-4685. | Up to 21 days. |
| Maximum tolerated dose (MTD) of SHR-4685. | Up to 24 months. |
| Recommended Phase II Dose (RP2D) of SHR-4685. | Up to 24 months. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The concentration of SHR-4685 in plasma will be determined. | At predefined intervals throughout the treatment period, up to 24 months. | Cmax will be derived. |
| Time to maximum concentration (Tmax). | At predefined intervals throughout the treatment period, up to 24 months. | Evaluation of pharmacokinetic parameter of SHR-4685. |
| Duration of response (DoR). | Up to 24 months. | Time from documentation of tumor response to disease progression assessed among patients who had an objective response. |
| Area under the concentration-time curve from time 0 to time t (time of the last measurable concentration) (AUC0-t). | At predefined intervals throughout the treatment period, up to 24 months. | Evaluation of pharmacokinetic parameter of SHR-4685. The concentration of SHR-4685 in plasma will be determined. Area under the curve is the integral of the concentration-time curve. The AUC reflects the actual body exposure to drug after administration. The AUC is dependent on the rate of elimination of the drug from the body and the dose administered. |
| Progression Free Survival (PFS). | Up to 24 months. | Time from C1D1 to first assessment of disease progression or death, whichever is earlier. |
| Objective Response Rate (ORR). | Up to 24 months. | Complete Response (CR) and Partial Response (PR) based on RECIST 1.1. |
| Disease control rate (DCR). | Up to 24 months. | Complete Response (CR), Partial Response (PR) and Stable Disease (SD) based on RECIST 1.1. |
| The concentration of Anti-SHR-4685 antibodies (ADA) in plasma will be determined. | At predefined intervals throughout the treatment period, up to 24 months. | — |
Countries
China
Contacts
CONTACTRan Zhao, M.D
Outcome results
None listed