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

NCT ID: NCT03722186

Last Updated: 2021-03-22

Basic Information

• Recruitment Status: SUSPENDED
• Clinical Phase: PHASE1
• Total Enrollment: 128 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-13
• Study Completion Date: 2021-10-31

Brief 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.

Detailed Description

SHR-1603-I-101 is a single-arm, open-label, dose finding, first-in-human(FIH) clinical trial of SHR-1603 intravenous infusion in subjects with advanced solid tumor or relapsed/refractory malignant lymphoid diseases.

The primary objective of this study is to evaluate the safety and tolerability of SHR-1603, as well as to determine the maximally tolerated dose(MTD) and define the recommended Phase 2 dose(RP2D) of SHR-1603.

The study is consisted of a dose-escalation Part 1 followed by a dose expansion Part 2 and a clinical expansion Part 3.

Part 1 will use accelerated titration and 3+3 dose-escalation design to determine MTD.

Part 2 will further evaluate the safety, tolerability and PK/PD features of SHR-1603 based on the results of Part 1.

Part 3 will include several cohorts of malignancies to collect preliminary efficacy information of SHR-1603.

Conditions

Physiological Effects of Drugs; Neoplasms by Histologic Type; Lymphoma; Hematologic Neoplasms; Immunotherapy; Advanced Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

SHR-1603

Multiple escalating doses of SHR-1603

Group Type: EXPERIMENTAL

SHR-1603

Intervention Type: DRUG

SHR-1603 monotherapy

Interventions

SHR-1603

SHR-1603 monotherapy

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jiangsu HengRui Medicine Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Shanghai East Hospital

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

SHR-1603-I-101

Identifier Type: -

Identifier Source: org_study_id