Advanced Solid Tumors
Conditions
Brief summary
This study is an open-label, phase I clinical trial of SHR-7631 in patients with advanced solid tumors. The whole study is divided into three stages: dose escalation, dose expansion and efficacy expansion.
Interventions
DRUGSHR-7631
The total dosage of SHR-7631 was calculated according to the weight weighing results of the subjects before each administration, and was administered by intravenous drip.
Sponsors
Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Study design
Allocation
NA
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. Patients with histologically or cytologically confirmed unresectable locally advanced or metastatic solid tumors which is relapsed or refractory to standard treatment, or lack of standard treatment, or standard treatment is not applicable currently; 2. Have at least one measurable tumor lesion per RECIST v1.1 (subject with only non-target tumor lesion will be permitted if he/she is planned to participant in dose escalation stage or with mCRPC); 3. ECOG performance status of 0-1; 4. Life expectancy ≥ 12 weeks; 5. Adequate bone marrow and organ function 6. Subjects must voluntarily agree to participate in the trial and sign a written informed consent form. 7. Age 18 to 75 years old (including both ends), gender is not limited;
Exclusion criteria
1. Patients with active central nervous system metastases or meningeal metastases; 2. Ongoing or previous anti-tumor therapies within 4 weeks prior to the first dose of study drug; 3. Prior treatment with antibody-drug conjugate (ADC) consisting of topoisomerase I inhibitors; 4. History of serious cardiovascular and cerebrovascular diseases; 5. Severe infection within 4 weeks prior to the first dose; 6. Adverse reactions of previous anti-tumor treatment have not recovered to Grade ≤ 1 per NCI-CTCAE v5.0.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum tolerated dose (MTD) or maximum administered dose (MAD) | 12 months |
| Incidence and severity of adverse events (AEs)/serious adverse events (SAEs) (CTCAE v5.0) | 36 months |
Secondary
| Measure | Time frame |
|---|---|
| PK parameter: AUC0-t | 36 months |
| PK parameter: AUC0-∞ | 36 months |
| PK parameter: Tmax | 36 months |
| PK parameter: MRT (mean residence time) | 36 months |
| PK parameter: t1/2 | 36 months |
| PK parameter: Cmax | 36 months |
Countries
China
Outcome results
None listed