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Clinical Trial Details — Status: Suspended

Administrative data

NCT number NCT03722186
Other study ID # SHR-1603-I-101
Secondary ID
Status Suspended
Phase Phase 1
First received
Last updated
Start date November 13, 2018
Est. completion date October 2021

Study information

Verified date March 2021
Source Jiangsu HengRui Medicine Co., Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Suspended
Enrollment 128
Est. completion date October 2021
Est. primary completion date April 4, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Intervention

Drug:
SHR-1603
SHR-1603 monotherapy

Locations

Country Name City State
China Shanghai East Hospital Shanghai Shanghai

Sponsors (1)

Lead Sponsor Collaborator
Jiangsu HengRui Medicine Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Adverse events(AE) of SHR-1603 Assessment of the incidence of treatment-emergent AEs 18 months (anticipated)
Primary Dose-limited toxicity (DLT) of SHR-1603 Assessment of the incidence of DLT 18 months(anticipated)
Primary Maximum tolerated dose (MTD) of SHR-1603 The highest dosing level at which no more than 1 of 6 patients has DLT 18 months(anticipated)
Secondary The peak plasma concentration (Cmax) of SHR-1603 The serum concentrations of SHR-1603 at each dose level, between the first and second intravenous administration. 18 months (anticipated)
Secondary The area under the plasma concentration versus time curve (AUC) of SHR-1603 The plot of SHR-1603 concentration in blood plasma versus time after intravenous infusion. 18 months (anticipated)
Secondary The half-life(t1/2) of SHR-1603 The time required for the serum concentration of SHR-1603 be reduced to half of its peak concentration. 18 months (anticipated)
Secondary The objective response rate(ORR) in subjects with advanced tumors treated with SHR-1603 The proportion of patients with reduction in tumor burden. RECIST 1.1(solid tumor) or LUGANO 2014(lymphoma) will be used for assessment. 36 months
Secondary The best of response (BOR) in subjects with advanced tumors treated with SHR-1603 The best response recorded from the start of the study treatment until the disease progression. RECIST 1.1(solid tumor) or LUGANO 2014(lymphoma) will be used for assessment. 36 months
Secondary The progression free survival (PFS) in subjects with advanced tumors treated with SHR-1603 Time from the first dose of SHR-1603 until disease progression or death. Disease progression will be determined according to RECIST 1.1(solid tumor) or LUGANO 2014(lymphoma). 36 months
Secondary The Duration of response (DoR) in subjects with advanced tumors treated with SHR-1603 Time from documentation of tumor response to disease progression. RECIST 1.1(solid tumor) or LUGANO 2014(lymphoma) will be used for assessment. 36 months
Secondary The disease control rate (DCR) in subjects with advanced tumors treated with SHR-1603 The percentage of subjects with solid tumor who have achieved complete response(CR), partial response(PR) and stable disease(SD) no less than 24 weeks since start of treatment. RECIST 1.1(solid tumor) or LUGANO 2014(lymphoma) will be used for assessment. 36 months
Secondary The clinical benefit rate (CBR) in subjects with advanced tumors treated with SHR-1603 The percentage of subjects with solid tumor who have achieved complete response(CR), partial response(PR) and stable disease(SD). RECIST 1.1(solid tumor) or LUGANO 2014(lymphoma) will be used for assessment. 36 months
Secondary SHR-1603 receptor occupation red blood cell and white blood cell surface receptor occupation will be assessed frequently 30 months
Secondary SHR-1603 antibodies anti SHR-1603 antibodies will be tested frequently 30 months
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