Malignant Solid Tumors
Conditions
Brief summary
This study is an open-label, multicenter Phase I/II clinical trial to evaluate the safety, tolerability, pharmacokinetics and efficacy of SHR-1681 for injection in patients with advanced solid tumors.
Interventions
DRUGSHR-1681
SHR-1681 for Injection will be administrated per dose level in which the patients are assigned.
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. Subjects must voluntarily agree to participate in the trial and sign a written informed consent form; 2. Subjects 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; 3. Have at least one measurable tumor lesion per RECIST v1.1; 4. ECOG performance score of 0-1; 5. Life expectancy ≥ 3 months; 6. Adequate bone marrow and organ function.
Exclusion criteria
1. Subjects with active central nervous system metastases or meningeal metastases; 2. History of serious cardiovascular and cerebrovascular diseases; 3. Subjects with a history of interstitial pneumonitis or imaging at screening suggestive of suspected interstitial pneumonitis; 4. Severe infection within 4 weeks prior to the first dose; 5. Ongoing or previous anti-tumor therapies within 4 weeks prior to the first dose of study drug; 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 |
|---|---|
| Incidence and severity of adverse events (AEs) | Approximately 3 years. |
| Incidence and severity of serious adverse events (SAEs) | Approximately 3 years. |
| Maximum tolerated dose (MTD) | 12 months. |
| Maximum administered dose (MAD) | 12 months. |
| Recommended Phase 2 dose (RP2D) | 12 months. |
Secondary
| Measure | Time frame |
|---|---|
| Area under the concentration-time curve from time 0 to the last measurable concentration time point (AUC0-t) of SHR-1681 | Approximately 3 years. |
| Area under the concentration-time curve from time 0 to infinity (AUC0-∞) of SHR-1681 | Approximately 3 years. |
| Anti-SHR-1681 antibody (ADA) of SHR-1681 | Approximately 3 years. |
| Overall response rate (ORR) | Approximately 3 years. |
| Duration of response (DoR) | Approximately 3 years. |
| Disease control rate (DCR) | Approximately 3 years. |
| Progression-free survival (PFS) | Approximately 3 years. |
| Overall survival (OS) | Approximately up to 5 years after the last subject enrolled. |
| Time to maximum concentration (Tmax) of SHR-1681 | Approximately 3 years. |
| Maximum concentration (Cmax) of SHR-1681 | Approximately 3 years. |
Countries
China
Contacts
Primary ContactFei Qiu
Backup ContactTing Lu, M.M
Outcome results
None listed