Advanced Solid Tumor
Conditions
Brief summary
This study is an open-label, phase I clinical trial of SHR-9839 in patients with advanced solid tumors. The whole study is divided into three stages: dose escalation, dose expansion and efficacy expansion.
Interventions
DRUGSHR-9839
Weekly fixed dose injection of SHR-9839
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 70 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; 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.
Exclusion criteria
1. Patients with active central nervous system metastases or meningeal metastases; 2. Received anti-tumor treatment such as chemotherapy, biotherapy, targeted therapy, immunotherapy, radical radiotherapy, or other unlisted clinical research drugs or treatments within 4 weeks prior to the first use of the study drug; 3. History of serious cardiovascular and cerebrovascular diseases; 4. Subjects who received\>30Gy of radiation therapy within 4 weeks before the first medication, and those who received ≤ 30Gy of palliative radiation therapy within 7 days before the first medication; 5. Adverse reactions of previous anti-tumor treatment have not recovered to Grade ≤ 1 per NCI-CTCAE v5.0.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum tolerated dose (MTD) or maximum administered dose (MAD) | On the first day of each week,4 weeks is a treatment cycle | Incidence and category of dose limiting toxicities (DLTs) during the first 4 week cycle of SHR-9839 treatment |
| Recommended Phase 2 dose (RP2D) | From Day 1 to 90 days after last dose | RP2D will be determined on the basis of evaluation on MTD/MAD, PK, PD, efficacy data in dose escalation and dose expansion stages. |
| Incidence and severity of adverse events (AEs)/serious adverse events (SAEs) ([CTCAE] v5.0) | From Day 1 to 90 days after last dose | Assess safety and tolerability of SHR-9839 by way of adverse events (CTCAE v5.0). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PK parameter: AUC0-∞ of SHR-9839 | Approximately 10 months | Area under the concentration-time curve from time 0 to infinity of SHR-9839 |
| Immunogenicity of SHR-9839 | Approximately 12 months | Anti-SHR-9839 antibody (ADA) |
| Overall response rate (ORR) | Approximately within 36 months | Evaluated using RECIST 1.1 |
| PK parameter: Tmax of SHR-9839 | approximately 10 months | Time to maximum concentration of SHR-9839 |
| Disease control rate (DCR) | Approximately within 36 months | Evaluated using RECIST 1.1 |
| Progression-free survival (PFS) | Approximately within 36 months | Evaluated using RECIST 1.1 |
| Duration of response (DoR) | Approximately within 36 months | Evaluated using RECIST 1.1 |
| PK parameter: Cmax of SHR-9839 | approximately 10 months | Maximum concentration of SHR-9839 |
| PK parameter: AUC0-t of SHR-9839 | Approximately 10 months | Area under the concentration-time curve from time 0 to the last measurable concentration time point of SHR-9839 |
Countries
China
Contacts
Primary ContactRongfu Mao, MD
Backup ContactJin Wang, COD
Outcome results
None listed