Safety, Tolerability and Pharmacokinetics/Pharmacodynamics (PK/PD) of SHR-1603 in Subjects With Advanced Malignancies

• Status: Suspended
• Trial end date: 2021-10-01
• Target enrollment: 0
• Participant gender: All

Summary

SHR-1603-I-101 is an single-arm, open-label, dose finding phase I clinical trial of SHR-1603 in subjects with advanced solid tumor or relapsed/refractory malignant lymphoid diseases. The study drug will be administered by intravenous infusion.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Criteria

Inclusion Criteria:

1. Ages 18 years or older;

2. Eastern Cooperative Oncology Group (ECOG) performance status 0-1;

3. Life expectancy no less than 12 weeks;

4. Pathologically confirmed advanced solid tumor or relapsed/refractory lymphoma with measurable target lesions;

5. Adequate bone marrow, haptic, renal and coagulation function.

Exclusion Criteria:

1. Evidence of central nervous system (CNS) involvement;

2. Previously treated with similar agents;

3. History of anticancer treatment within 4 weeks of enrollment (6 weeks for subjects treated with nitrosoureas or mitomycins);

4. Anticipated to be involved in other anti-cancer treatments expect for palliative care during the trial;

5. History of anti-cancer vaccination; or history of vaccination using attenuated vaccines within 4 weeks of enrollment;

6. History of Red blood cell (RBC) transfusion within or treatment with erythropoitin(EPO) within 3 months of enrollment;

7. History of grade 3 or higher thrombolic incidence within 2 years of enrollment, or using antithrombotic/anticoagulant agents;

8. With confirmed immunodeficiency, uncontrolled auto-immune disease, uncontrolled cardiovascular disease, uncontrolled or active infection;

9. Substance abuse.